HEADER RECORD*******LIBRARY HEADER RECORD!!!!!!!000000000000000000000000000000 SAS SAS SASLIB 6.06 MAC1. 26FEB25:12:36:3726FEB25:12:36:37 HEADER RECORD*******MEMBER HEADER RECORD!!!!!!!000000000000000001600000000140 HEADER RECORD*******DSCRPTR HEADER RECORD!!!!!!!000000000000000000000000000000 SAS _1257722SASDATA 6.06 26FEB25:12:36:3726FEB25:12:36:37 Protocol Deviations HEADER RECORD*******NAMESTR HEADER RECORD!!!!!!!000000001100000000000000000000 STUDYID Study Identifier DOMAIN Domain Abbreviation USUBJID Unique Subject Identifier  SUBJID Subject Identifier for the Study )DVSEQ Sequence Number BEST  2DVTERM Protocol Deviation Term :DVCAT Category for Protocol Deviation DVSCAT Subcategory for Protocol Deviation  EPOCH Epoch 1 DVSTDTC Start Date/Time of Deviation : DVSTDY Study Day of Start of Deviation BEST  D HEADER RECORD*******OBS HEADER RECORD!!!!!!!000000000000000000000000000000 mRNA-1273-P201DVmRNA-1273-P201-US201-1011US2011011AP08: LAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL. (EXPIRED TUBES, AMBIENT SHIPMENT, INCORRECT LAB KIT USED) Protocol DeviationStudy Procedures/Assessments TREATMENT2020-05-29AmRNA-1273-P201DVmRNA-1273-P201-US201-1040US2011040AP05: SUBJECT RECEIVED VACCINE IN DIFFERENT ARMS ON DAY 1 AND DAY 29 Protocol DeviationStudy Treatment Admin/DispenseFOLLOW-UP2020-07-28B:mRNA-1273-P201DVmRNA-1273-P201-US201-1041US2011041AP07 SUBJECT DIARY HAS 2 OR MORE DAYS OF SOLICITED ENTRIES MISSING Protocol DeviationMissing Endpoint Assessments TREATMENT2020-07-07B$mRNA-1273-P201DVmRNA-1273-P201-US201-1041US2011041A P07: SUBJECT DIARY HAS 2 OR MORE DAYS OF SOLICITED ENTRIES MISSING Protocol DeviationMissing Endpoint Assessments TREATMENT2020-06-10AmRNA-1273-P201DVmRNA-1273-P201-US201-1042US2011042AP07 SUBJECT DIARY HAS 2 OR MORE DAYS OF SOLICITED ENTRIES MISSING Protocol DeviationMissing Endpoint Assessments TREATMENT2020-07-13B$mRNA-1273-P201DVmRNA-1273-P201-US201-1055US2011055AP07 SUBJECT DIARY HAS 2 OR MORE DAYS OF SOLICITED ENTRIES MISSING Protocol DeviationMissing Endpoint Assessments TREATMENT2020-07-07B$mRNA-1273-P201DVmRNA-1273-P201-US201-1059US2011059AP08 LAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL. (EXPIRED TUBES, AMBIENT SHIPMENT, INCORRECT LAB KIT USED) Protocol DeviationStudy Procedures/Assessments TREATMENT2020-06-30BmRNA-1273-P201DVmRNA-1273-P201-US201-1067US2011067AP10: VISIT NOT PERFORMED (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS) Protocol DeviationVisit Scheduling TREATMENT2020-06-10AmRNA-1273-P201DVmRNA-1273-P201-US201-1070US2011070AP07 SUBJECT DIARY HAS 2 OR MORE DAYS OF SOLICITED ENTRIES MISSING Protocol DeviationMissing Endpoint Assessments TREATMENT2020-06-12AmRNA-1273-P201DVmRNA-1273-P201-US201-1070US2011070A P07: SUBJECT DIARY HAS 2 OR MORE DAYS OF SOLICITED ENTRIES MISSING Protocol DeviationMissing Endpoint Assessments TREATMENT2020-06-10A`mRNA-1273-P201DVmRNA-1273-P201-US201-1070US2011070A0P10 VISIT NOT PERFORMED (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS) Protocol DeviationVisit Scheduling TREATMENT2020-06-12AmRNA-1273-P201DVmRNA-1273-P201-US201-1087US2011087AP07 SUBJECT DIARY HAS 2 OR MORE DAYS OF SOLICITED ENTRIES MISSING Protocol DeviationMissing Endpoint Assessments TREATMENT2020-07-08B$mRNA-1273-P201DVmRNA-1273-P201-US201-1088US2011088AP07 SUBJECT DIARY HAS 2 OR MORE DAYS OF SOLICITED ENTRIES MISSING Protocol DeviationMissing Endpoint Assessments TREATMENT2020-07-14B)mRNA-1273-P201DVmRNA-1273-P201-US201-1103US2011103AP07 SUBJECT DIARY HAS 2 OR MORE DAYS OF SOLICITED ENTRIES MISSING Protocol DeviationMissing Endpoint Assessments TREATMENT2020-07-07BmRNA-1273-P201DVmRNA-1273-P201-US201-1121US2011121AP05: SUBJECT RECEIVED VACCINE IN DIFFERENT ARMS ON DAY 1 AND DAY 29 Protocol DeviationStudy Treatment Admin/DispenseFOLLOW-UP2020-08-28B:mRNA-1273-P201DVmRNA-1273-P201-US201-1122US2011122AP07.01 IMMUNOGENICITY RESULTS NOT AVAILABLE (ANTIBODY-MEDIATED IMMUNOGENICITY SAMPLES NOT COLLECTED) Protocol DeviationVisit Scheduling FOLLOW-UP2020-08-21B9mRNA-1273-P201DVmRNA-1273-P201-US201-1122US2011122A P10 VISIT NOT PERFORMED (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS) Protocol DeviationVisit Scheduling FOLLOW-UP2020-08-21B9mRNA-1273-P201DVmRNA-1273-P201-US201-1124US2011124AP07 SUBJECT DIARY HAS 2 OR MORE DAYS OF SOLICITED ENTRIES MISSING Protocol DeviationMissing Endpoint Assessments TREATMENT2020-07-31B$mRNA-1273-P201DVmRNA-1273-P201-US201-1128US2011128AP08 LAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL. (EXPIRED TUBES, AMBIENT SHIPMENT, INCORRECT LAB KIT USED) Protocol DeviationStudy Procedures/Assessments TREATMENT2020-06-30AmRNA-1273-P201DVmRNA-1273-P201-US201-1156US2011156AP05: SUBJECT RECEIVED VACCINE IN DIFFERENT ARMS ON DAY 1 AND DAY 29 Protocol DeviationStudy Treatment Admin/DispenseFOLLOW-UP2020-08-26B:mRNA-1273-P201DVmRNA-1273-P201-US201-1162US2011162AP08 LAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL. (EXPIRED TUBES, AMBIENT SHIPMENT, INCORRECT LAB KIT USED) Protocol DeviationStudy Procedures/Assessments SCREENING2020-07-01PmRNA-1273-P201DVmRNA-1273-P201-US202-1003US2021003ASOURCE DOCUMENTATION DOSE NOT MEET ALCOA - STEPS IN THE DOSE ADMINISTRATION AND PREPARATION WORKSHEETS CONTAINS THE INITIALS OF THE VERIFIER INSTEAD OF THE INITIALS OF THE INDIVIDUAL WHO COMPETED THEICH/GCP Deviation Inv Record Keeping Source DocsTREATMENT2020-05-29AmRNA-1273-P201DVmRNA-1273-P201-US202-1004US2021004ASOURCE DOCUMENTATION DOSE NOT MEET ALCOA - STEPS IN THE DOSE ADMINISTRATION AND PREPARATION WORKSHEETS CONTAINS THE INITIALS OF THE VERIFIER INSTEAD OF THE INITIALS OF THE INDIVIDUAL WHO COMPETED THEICH/GCP Deviation Inv Record Keeping Source DocsTREATMENT2020-05-29AmRNA-1273-P201DVmRNA-1273-P201-US202-1007US2021007ASOURCE DOCUMENTATION DOSE NOT MEET ALCOA - STEPS IN THE DOSE ADMINISTRATION AND PREPARATION WORKSHEETS CONTAINS THE INITIALS OF THE VERIFIER INSTEAD OF THE INITIALS OF THE INDIVIDUAL WHO COMPETED ICH/GCP Deviation Inv Record Keeping Source DocsTREATMENT2020-06-01AmRNA-1273-P201DVmRNA-1273-P201-US202-1011US2021011ASOURCE DOCUMENTATION DOSE NOT MEET ALCOA - STEPS IN THE DOSE ADMINISTRATION AND PREPARATION WORKSHEETS CONTAINS THE INITIALS OF THE VERIFIER INSTEAD OF THE INITIALS OF THE INDIVIDUAL WHO COMPETED THEICH/GCP Deviation Inv Record Keeping Source DocsTREATMENT2020-05-29AmRNA-1273-P201DVmRNA-1273-P201-US202-1012US2021012ASOURCE DOCUMENTATION DOSE NOT MEET ALCOA - STEPS IN THE DOSE ADMINISTRATION AND PREPARATION WORKSHEETS CONTAINS THE INITIALS OF THE VERIFIER INSTEAD OF THE INITIALS OF THE INDIVIDUAL WHO COMPETED THEICH/GCP Deviation Inv Record Keeping Source DocsTREATMENT2020-06-01AmRNA-1273-P201DVmRNA-1273-P201-US202-1015US2021015ASOURCE DOCUMENTATION DOSE NOT MEET ALCOA - STEPS IN THE DOSE ADMINISTRATION AND PREPARATION WORKSHEETS CONTAINS THE INITIALS OF THE VERIFIER INSTEAD OF THE INITIALS OF THE INDIVIDUAL WHO COMPETED THEICH/GCP Deviation Inv Record Keeping Source DocsTREATMENT2020-05-29AmRNA-1273-P201DVmRNA-1273-P201-US202-1018US2021018AP10: US2021018- VISIT 4 DAY 29 WAS DELAYED DUE TO COVID-19 IMPACT. SUBJECT WAS AWAITING COVID TEST RESULTS. UPON RECEIVING NEGATIVE TEST RESULTS, SUBJECT RESUMED VISIT 4 DAY 29 AND ALL ASSESSMENTS. Protocol DeviationVisit Scheduling TREATMENT2020-07-13B.mRNA-1273-P201DVmRNA-1273-P201-US202-1018US2021018A SOURCE DOCUMENTATION DOSE NOT MEET ALCOA - STEPS IN THE DOSE ADMINISTRATION AND PREPARATION WORKSHEETS CONTAINS THE INITIALS OF THE VERIFIER INSTEAD OF THE INITIALS OF THE INDIVIDUAL WHO COMPETED THEICH/GCP Deviation Inv Record Keeping Source DocsTREATMENT2020-05-29AmRNA-1273-P201DVmRNA-1273-P201-US202-1019US2021019ASOURCE DOCUMENTATION DOSE NOT MEET ALCOA - STEPS IN THE DOSE ADMINISTRATION AND PREPARATION WORKSHEETS CONTAINS THE INITIALS OF THE VERIFIER INSTEAD OF THE INITIALS OF THE INDIVIDUAL WHO COMPETED THEICH/GCP Deviation Inv Record Keeping Source DocsTREATMENT2020-05-29AmRNA-1273-P201DVmRNA-1273-P201-US202-1020US2021020ASOURCE DOCUMENTATION DOSE NOT MEET ALCOA - STEPS IN THE DOSE ADMINISTRATION AND PREPARATION WORKSHEETS CONTAINS THE INITIALS OF THE VERIFIER INSTEAD OF THE INITIALS OF THE INDIVIDUAL WHO COMPETED THEICH/GCP Deviation Inv Record Keeping Source DocsTREATMENT2020-06-01AmRNA-1273-P201DVmRNA-1273-P201-US202-1021US2021021ASOURCE DOCUMENTATION DOSE NOT MEET ALCOA - STEPS IN THE DOSE ADMINISTRATION AND PREPARATION WORKSHEETS CONTAINS THE INITIALS OF THE VERIFIER INSTEAD OF THE INITIALS OF THE INDIVIDUAL WHO COMPETED THEICH/GCP Deviation Inv Record Keeping Source DocsTREATMENT2020-05-29AmRNA-1273-P201DVmRNA-1273-P201-US202-1022US2021022ASOURCE DOCUMENTATION DOSE NOT MEET ALCOA - STEPS IN THE DOSE ADMINISTRATION AND PREPARATION WORKSHEETS CONTAINS THE INITIALS OF THE VERIFIER INSTEAD OF THE INITIALS OF THE INDIVIDUAL WHO COMPETED THEICH/GCP Deviation Inv Record Keeping Source DocsTREATMENT2020-06-01AmRNA-1273-P201DVmRNA-1273-P201-US202-1031US2021031ASOURCE DOCUMENTATION DOSE NOT MEET ALCOA - STEPS IN THE DOSE ADMINISTRATION AND PREPARATION WORKSHEETS CONTAINS THE INITIALS OF THE VERIFIER INSTEAD OF THE INITIALS OF THE INDIVIDUAL WHO COMPETED THEICH/GCP Deviation Inv Record Keeping Source DocsTREATMENT2020-06-01AmRNA-1273-P201DVmRNA-1273-P201-US202-1086US2021086AP10: VISIT 5 COMPLETED 11 DAYS AFTER VISIT 4 Protocol DeviationVisit Scheduling SCREENING2020-08-07.mRNA-1273-P201DVmRNA-1273-P201-US202-1094US2021094AP10: US2021094- VISIT 4 DAY 29 PROCEDURES AND ASSESSMENTS WERE MISSED DUE TO COVID-19 IMPACT. SUBJECT WAS AWAITING COVID TEST RESULTS. Protocol DeviationStudy Procedures/Assessments TREATMENT2020-07-06B mRNA-1273-P201DVmRNA-1273-P201-US202-1094US2021094A P10: US2021094- VISIT 5 WERE COMPLETED OVER THE PHONE AND PROCEDURES AND ASSESSMENTS WERE MISSED DUE TO COVID-19 IMPACT. Protocol DeviationStudy Procedures/Assessments FOLLOW-UP2020-07-15B)mRNA-1273-P201DVmRNA-1273-P201-US202-1094US2021094A0P10: US2021094- VISIT 6 WERE COMPLETED OVER THE PHONE AND PROCEDURES AND ASSESSMENTS WERE MISSED DUE TO COVID-19 IMPACT. Protocol DeviationStudy Procedures/Assessments FOLLOW-UP2020-07-17B+mRNA-1273-P201DVmRNA-1273-P201-US202-1094US2021094A@P10: US2021094- VISIT 7 WERE COMPLETED OVER THE PHONE AND PROCEDURES AND ASSESSMENTS WERE MISSED DUE TO COVID-19 IMPACT. Protocol DeviationStudy Procedures/Assessments FOLLOW-UP2020-08-06B?mRNA-1273-P201DVmRNA-1273-P201-US202-1135US2021135AP07: SUBJECT US2021135 DIARY HAS 2 OR MORE DAYS OF SOLICITED ENTRIES MISSING. EDIARY NOT COMPLETED AT D1 AFTER VACCINATION(6.5.2020), D2 (6.6.2020) Protocol DeviationMissing Endpoint Assessments TREATMENT2020-06-06A mRNA-1273-P201DVmRNA-1273-P201-US202-1137US2021137AP10: US2021137- VISIT 5 WERE COMPLETED OVER THE PHONE AND PROCEDURES AND ASSESSMENTS WERE MISSED DUE TO COVID-19 IMPACT. Protocol DeviationStudy Procedures/Assessments TREATMENT2020-07-15B&mRNA-1273-P201DVmRNA-1273-P201-US202-1137US2021137A P10: US2021137 VISIT 6 WERE COMPLETED OVER THE PHONE AND PROCEDURES AND ASSESSMENTS WERE MISSED DUE TO COVID-19 IMPACT. Protocol DeviationStudy Procedures/Assessments TREATMENT2020-07-21B,mRNA-1273-P201DVmRNA-1273-P201-US202-1137US2021137A0P10: US2021137- VISIT 7 PROCEDURES AND ASSESSMENTS WERE COMPLETED OUT OF WINDOW DUE TO COVID-19 IMPACT. CONVALESCENT VISIT OCCURRED ON 11AUG2020. Protocol DeviationStudy Procedures/Assessments FOLLOW-UP2020-08-18BHmRNA-1273-P201DVmRNA-1273-P201-US202-1144US2021144AP10: US2021144- VISIT 7 WERE COMPLETED OVER THE PHONE AND PROCEDURES AND ASSESSMENTS WERE MISSED DUE TO COVID-19 IMPACT. Protocol DeviationStudy Procedures/Assessments FOLLOW-UP2020-08-10BCmRNA-1273-P201DVmRNA-1273-P201-US202-1162US2021162AP10: US2021162 MISSED VISIT 2 DUE TO A FALSE POSITIVE COVID-19 LAB RESULT ON DAY 1 FROM VIRACOR LAB. Protocol DeviationStudy Procedures/Assessments FOLLOW-UP2020-06-16AmRNA-1273-P201DVmRNA-1273-P201-US202-1162US2021162A P10: US2021162 MISSED VISIT 3 DUE TO A FALSE POSITIVE COVID-19 LAB RESULT ON DAY 1 FROM CENTRAL LAB. Protocol DeviationStudy Procedures/Assessments FOLLOW-UP2020-06-23BmRNA-1273-P201DVmRNA-1273-P201-US202-1162US2021162A0P10: US2021162 MISSED VISIT 4 DAY 29 VACCINATION 2 DUE TO A FALSE POSITIVE COVID-19 LAB RESULT ON DAY 1 FROM VIRACOR LAB. Protocol DeviationStudy Procedures/Assessments FOLLOW-UP2020-07-13B$mRNA-1273-P201DVmRNA-1273-P201-US202-1164US2021164AP10: (VISITS WHERE IMMUNOGENECITY SAMPLES ARE COLLECTED) VISIT 6 COMPLETED 19 DAYS AFTER VISIT 4 Protocol DeviationVisit Scheduling TREATMENT2020-08-07B=mRNA-1273-P201DVmRNA-1273-P201-US202-1182US2021182AP10: (VISITS WHERE IMMUNOGENECITY SAMPLES ARE COLLECTED) Protocol DeviationVisit Scheduling FOLLOW-UP2020-07-31B6mRNA-1273-P201DVmRNA-1273-P201-US202-1198US2021198AP10.3 VISIT 4 (VACCINE 2) SHOULD HAVE OCCURRED NO LATER THAN 03AUG2020 Protocol DeviationVisit Scheduling TREATMENT2020-08-18B3mRNA-1273-P201DVmRNA-1273-P201-US202-1207US2021207AP10.3 VISIT 4 (VACCINE 2) SHOULD HAVE OCCURRED NO LATER THAN 31JUL2020 Protocol DeviationVisit Scheduling TREATMENT2020-08-06B*mRNA-1273-P201DVmRNA-1273-P201-US202-1208US2021208AP.10: US2021208 V2 D8 OCCURRED 2 DAYS OUT OF WINDOW. Protocol DeviationVisit Scheduling TREATMENT2020-08-05B$mRNA-1273-P201DVmRNA-1273-P201-US202-1208US2021208A P10: US2021208 VISIT 6 WERE COMPLETED OVER THE PHONE AND PROCEDURES AND ASSESSMENTS WERE MISSED DUE TO COVID-19 IMPACT. Protocol DeviationStudy Procedures/Assessments TREATMENT2020-08-19B2mRNA-1273-P201DVmRNA-1273-P201-US202-1208US2021208A0P10: (VISITS WHERE IMMUNOGENECITY SAMPLES ARE COLLECTED) Protocol DeviationVisit Scheduling FOLLOW-UP2020-09-08BFmRNA-1273-P201DVmRNA-1273-P201-US202-1215US2021215AP10: (VISITS WHERE IMMUNOGENECITY SAMPLES ARE COLLECTED) Protocol DeviationVisit Scheduling FOLLOW-UP2020-09-08BHmRNA-1273-P201DVmRNA-1273-P201-US203-1016US2031016AP08 : STUDY PROCEDURES/ASSESSMENTS (LAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL). ON 04JUN2020, THE SITE COLLECTED COVID AND BIOFIRE SAMPLES, HOWEVER THE Protocol DeviationStudy Procedures/Assessments TREATMENT2020-06-08APmRNA-1273-P201DVmRNA-1273-P201-US203-1042US2031042AP08 : STUDY PROCEDURES/ASSESSMENTS (LAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL). ON 04JUN2020, THE SITE COLLECTED COVID AND BIOFIRE SAMPLES, HOWEVER THE Protocol DeviationStudy Procedures/Assessments TREATMENT2020-06-04AmRNA-1273-P201DVmRNA-1273-P201-US203-1043US2031043AP08 : STUDY PROCEDURES/ASSESSMENTS (LAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL). ON 04JUN2020, THE SITE COLLECTED COVID AND BIOFIRE SAMPLES, HOWEVER THE Protocol DeviationStudy Procedures/Assessments TREATMENT2020-06-04AmRNA-1273-P201DVmRNA-1273-P201-US203-1060US2031060AP08 : STUDY PROCEDURES/ASSESSMENTS (LAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL). ON 04JUN2020, THE SITE COLLECTED COVID AND BIOFIRE SAMPLES, HOWEVER THE Protocol DeviationStudy Procedures/Assessments TREATMENT2020-06-04AmRNA-1273-P201DVmRNA-1273-P201-US203-1062US2031062AP08 : STUDY PROCEDURES/ASSESSMENTS (LAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL). ON 04JUN2020, THE SITE COLLECTED COVID AND BIOFIRE SAMPLES, HOWEVER THE Protocol DeviationStudy Procedures/Assessments TREATMENT2020-06-04AmRNA-1273-P201DVmRNA-1273-P201-US203-1071US2031071AP08 : STUDY PROCEDURES/ASSESSMENTS (LAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL). ON 04JUN2020, THE SITE COLLECTED COVID AND BIOFIRE SAMPLES, HOWEVER THE Protocol DeviationStudy Procedures/Assessments TREATMENT2020-06-04AmRNA-1273-P201DVmRNA-1273-P201-US203-1079US2031079AP08 : STUDY PROCEDURES/ASSESSMENTS (LAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL). ON 04JUN2020, THE SITE COLLECTED COVID AND BIOFIRE SAMPLES, HOWEVER THE Protocol DeviationStudy Procedures/Assessments TREATMENT2020-06-04AmRNA-1273-P201DVmRNA-1273-P201-US203-1080US2031080AP08 : STUDY PROCEDURES/ASSESSMENTS (LAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL). ON 04JUN2020, THE SITE COLLECTED COVID AND BIOFIRE SAMPLES, HOWEVER THE Protocol DeviationStudy Procedures/Assessments TREATMENT2020-06-04AmRNA-1273-P201DVmRNA-1273-P201-US203-1081US2031081A(P08 : STUDY PROCEDURES/ASSESSMENTS) LAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL. US2031081-COVID PCR SWAB SHIPPED DIRECTLY TO VIRACOR AND NOT PPD CENTRAL LAB,Protocol DeviationStudy Procedures/Assessments FOLLOW-UP2020-08-03B=mRNA-1273-P201DVmRNA-1273-P201-US203-1082US2031082AP08 : STUDY PROCEDURES/ASSESSMENTS (LAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL). ON 04JUN2020, THE SITE COLLECTED COVID AND BIOFIRE SAMPLES, HOWEVER THE Protocol DeviationStudy Procedures/Assessments SCREENING2020-06-04.mRNA-1273-P201DVmRNA-1273-P201-US203-1101US2031101A(P10: VISIT SCHEDULING; VISIT PERFORMED OUT OF WINDOW)- SUBJECT US2031101- VISIT 3 DAY 15 PERFORMED OUT OF WINDOW (+/- 3 DAYS). Protocol DeviationVisit Scheduling TREATMENT2020-07-20BmRNA-1273-P201DVmRNA-1273-P201-US203-1107US2031107AP10: (VISITS WHERE IMMUNOGENECITY SAMPLES ARE COLLECTED) Protocol DeviationVisit Scheduling FOLLOW-UP2020-09-02BBmRNA-1273-P201DVmRNA-1273-P201-US203-1108US2031108AP08 : STUDY PROCEDURES/ASSESSMENTS (LAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL). THE REQ ID LISTED FOR VISIT 6 PAPER REQ IN SUBJECT CHART (1EH33890307) DATEDProtocol DeviationStudy Procedures/Assessments TREATMENT2020-08-20B.mRNA-1273-P201DVmRNA-1273-P201-US203-1112US2031112A(P10 : VISIT SCHEDULING)- VISIT COMPLETED OUT OF WINDOW: V7/DAY57 VISIT FOR SUBJECT US2031112 WAS OUT OF WINDOW PER PROTOCOL (>35 DAYS FROM LAST VACCINATION). Protocol DeviationStudy Procedures/Assessments FOLLOW-UP2020-09-02BEmRNA-1273-P201DVmRNA-1273-P201-US203-1116US2031116A(P08 : STUDY PROCEDURES/ASSESSMENTS) LAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL. US2031116-COVID PCR SWAB SHIPPED DIRECTLY TO VIRACOR AND NOT PPD CENTRAL LAB,Protocol DeviationStudy Procedures/Assessments FOLLOW-UP2020-08-28B=mRNA-1273-P201DVmRNA-1273-P201-US204-1008US2041008AP10: (VISITS WHERE IMMUNOGENECITY SAMPLES ARE COLLECTED) Protocol DeviationVisit Scheduling FOLLOW-UP2020-08-11BHmRNA-1273-P201DVmRNA-1273-P201-US204-1011US2041011AP10: VISIT COMPLETED OUT OF WINDOW Protocol DeviationVisit Scheduling TREATMENT2020-06-15AmRNA-1273-P201DVmRNA-1273-P201-US204-1011US2041011A P10: VISIT COMPLETED OUT OF WINDOW Protocol DeviationVisit Scheduling FOLLOW-UP2020-08-17BNmRNA-1273-P201DVmRNA-1273-P201-US204-1014US2041014AP10: VISIT COMPLETED OUT OF WINDOW Protocol DeviationVisit Scheduling TREATMENT2020-07-08B)mRNA-1273-P201DVmRNA-1273-P201-US204-1016US2041016AP10.3 SUBJECT 2041016 VISIT 4 (VACCINE 2) SHOULD HAVE OCCURRED NO LATER THAN 06JUL2020 WHICH INCLUDES THE +7 DAYS ALLOWED PER THE PROTOCOL. Protocol DeviationVisit Scheduling TREATMENT2020-07-06B#mRNA-1273-P201DVmRNA-1273-P201-US204-1019US2041019AP07_SUBJECT DIARY HAS 2 OR MORE DAYS OF SOLICITED ENTRIES MISSING. Protocol DeviationMissing Endpoint Assessments TREATMENT2020-07-14B+mRNA-1273-P201DVmRNA-1273-P201-US204-1019US2041019A P10_VISIT COMPLETED OUT OF WINDOW. (V7D57 OUT OF WINDOW) Protocol DeviationVisit Scheduling TREATMENT2020-07-28B9mRNA-1273-P201DVmRNA-1273-P201-US204-1026US2041026AP08_PROCEDURE NOT PERFORMED Protocol DeviationStudy Procedures/Assessments TREATMENT2020-06-30BmRNA-1273-P201DVmRNA-1273-P201-US204-1046US2041046AP10: VISIT COMPLETED OUT OF WINDOW Protocol DeviationVisit Scheduling TREATMENT2020-06-15AmRNA-1273-P201DVmRNA-1273-P201-US204-1049US2041049AP10.3 SUBJECT 2041049 VISIT 4 (VACCINE 2) SHOULD HAVE OCCURRED NO LATER THAN 08JUL2020 WHICH INCLUDES THE +7 DAYS ALLOWED PER THE PROTOCOL. HOWEVER, DUE TO THE SITE NOT HAVING NEEDLES THE SUBJECT Protocol DeviationVisit Scheduling TREATMENT2020-07-08B#mRNA-1273-P201DVmRNA-1273-P201-US204-1055US2041055AP10.3 SUBJECT 2041055 VISIT 4 (VACCINE 2) SHOULD HAVE OCCURRED NO LATER THAN 07JUL2020 WHICH INCLUDES THE +7 DAYS ALLOWED PER THE PROTOCOL. HOWEVER, DUE TO THE SITE NOT HAVING NEEDLES THE SUBJECT Protocol DeviationVisit Scheduling TREATMENT2020-07-07B#mRNA-1273-P201DVmRNA-1273-P201-US204-1055US2041055A P10: VISIT COMPLETED OUT OF WINDOW Protocol DeviationVisit Scheduling TREATMENT2020-06-25BmRNA-1273-P201DVmRNA-1273-P201-US204-1056US2041056AP07: SUBJECT DIARY NOT COMPLETED (IN ENTIRETY) FOR SAFETY DATA COLLECTION Protocol DeviationMissing Endpoint Assessments TREATMENT2020-06-30BmRNA-1273-P201DVmRNA-1273-P201-US204-1058US2041058AP10.3 SUBJECT 2041058 VISIT 4 (VACCINE 2) SHOULD HAVE OCCURRED NO LATER THAN 07JUL2020 WHICH INCLUDES THE +7 DAYS ALLOWED PER THE PROTOCOL. HOWEVER, DUE TO THE SITE NOT HAVING NEEDLES THE SUBJECT Protocol DeviationVisit Scheduling TREATMENT2020-07-07B#mRNA-1273-P201DVmRNA-1273-P201-US204-1059US2041059AP10.3 SUBJECT 2041059 VISIT 4 (VACCINE 2) SHOULD HAVE OCCURRED NO LATER THAN 06JUL2020 WHICH INCLUDES THE +7 DAYS ALLOWED PER THE PROTOCOL. HOWEVER, DUE TO THE SITE NOT HAVING NEEDLES THE SUBJECT Protocol DeviationVisit Scheduling TREATMENT2020-07-06B#mRNA-1273-P201DVmRNA-1273-P201-US204-1060US2041060AI02.01_RECONSENT NOT COLLECTED FOR NEW ICF VERSION 3.0 (US2041060 AT VISIT 7) ICH/GCP Deviation ICF Process/Timing FOLLOW-UP2020-08-18BNmRNA-1273-P201DVmRNA-1273-P201-US204-1060US2041060A P10_VISIT COMPLETED OUT OF WINDOW. (V7D57 OUT OF WINDOW) Protocol DeviationVisit Scheduling FOLLOW-UP2020-08-18BNmRNA-1273-P201DVmRNA-1273-P201-US204-1061US2041061AP10_VISIT COMPLETED OUT OF WINDOW. (V7D57 OUT OF WINDOW) Protocol DeviationVisit Scheduling FOLLOW-UP2020-08-13BImRNA-1273-P201DVmRNA-1273-P201-US204-1064US2041064AP10: THE PI DID NOT ENSURE ADHERENCE TO PROTOCOL PROCEDURES AS FOLLOWS: SUBJECT US2041064 VISIT 1 WAS CONDUCTED ON 08JUN2020. VISIT 4 WAS CONDUCTED ON 14JUL2020, ONE DAY OUTSIDE OF THE ALLOWABLE Protocol DeviationVisit Scheduling TREATMENT2020-07-14B%mRNA-1273-P201DVmRNA-1273-P201-US204-1064US2041064A P10_VISIT NOT PERFORMED. (US2041064, VISIT 3 NOT PERFORMED) Protocol DeviationVisit Scheduling TREATMENT2020-07-14B%mRNA-1273-P201DVmRNA-1273-P201-US204-1075US2041075AP10: VISIT COMPLETED OUT OF WINDOW Protocol DeviationVisit Scheduling TREATMENT2020-07-13B*mRNA-1273-P201DVmRNA-1273-P201-US204-1075US2041075A P10: VISIT COMPLETED OUT OF WINDOW Protocol DeviationVisit Scheduling TREATMENT2020-07-21B2mRNA-1273-P201DVmRNA-1273-P201-US204-1077US2041077AP07: SUBJECT DIARY HAS 2 OR MORE DAYS OF SOLICITED ENTRIES MISSING Protocol DeviationMissing Endpoint Assessments TREATMENT2020-07-01BmRNA-1273-P201DVmRNA-1273-P201-US204-1078US2041078AP07: SUBJECT DIARY HAS 2 OR MORE DAYS OF SOLICITED ENTRIES MISSING Protocol DeviationMissing Endpoint Assessments TREATMENT2020-07-01BmRNA-1273-P201DVmRNA-1273-P201-US204-1090US2041090AP08.99 NASOPHARYNGEAL SWAB COLLECTIONS AT DAY 29 LEAKED VIAL. Protocol DeviationStudy Procedures/Assessments TREATMENT2020-07-14B%mRNA-1273-P201DVmRNA-1273-P201-US204-1090US2041090A P08_PROCEDURE NOT PERFORMED Protocol DeviationStudy Procedures/Assessments TREATMENT2020-07-20B+mRNA-1273-P201DVmRNA-1273-P201-US204-1091US2041091AP08_PROCEDURE NOT PERFORMED Protocol DeviationStudy Procedures/Assessments TREATMENT2020-07-20B)mRNA-1273-P201DVmRNA-1273-P201-US204-1092US2041092AP10.3 SUBJECT 2041092 VISIT 4 (VACCINE 2) SHOULD HAVE OCCURRED NO LATER THAN 13JUL2020 WHICH INCLUDES THE +7 DAYS ALLOWED PER THE PROTOCOL. HOWEVER, DUE TO THE SITE NOT HAVING NEEDLES THE SUBJECT Protocol DeviationVisit Scheduling TREATMENT2020-07-13B$mRNA-1273-P201DVmRNA-1273-P201-US204-1092US2041092A P10: THE PI DID NOT ENSURE ADHERENCE TO PROTOCOL PROCEDURES AS FOLLOWS: SUBJECT 204-1092 THE SUBJECT RETURNED FOR VISIT 4 (SECOND DOSING VISIT) ON 14JUL2020 OUTSIDE THE ALLOWABLE WINDOW (>35 DAYS Protocol DeviationVisit Scheduling TREATMENT2020-07-14B%mRNA-1273-P201DVmRNA-1273-P201-US204-1094US2041094AP10_VISIT COMPLETED OUT OF WINDOW. (V6D43 OUT OF WINDOW.) Protocol DeviationVisit Scheduling TREATMENT2020-08-11B/mRNA-1273-P201DVmRNA-1273-P201-US204-1107US2041107AP10_V28 OCCURRED >3 DAYS OUT OF WINDOW. Protocol DeviationVisit Scheduling TREATMENT2020-07-09AmRNA-1273-P201DVmRNA-1273-P201-US204-1112US2041112AP10: VISIT COMPLETED OUT OF WINDOW Protocol DeviationVisit Scheduling TREATMENT2020-08-18B6mRNA-1273-P201DVmRNA-1273-P201-US204-1113US2041113AP07_DOSE DIARY 1- SUBJECT MISSED DAY 6-DAY 7 EDIARY ENTRY. Protocol DeviationMissing Endpoint Assessments TREATMENT2020-07-05A`mRNA-1273-P201DVmRNA-1273-P201-US204-1113US2041113A P07_DOSE DIARY 2- SUBJECT MISSED DAY4-DAY 7 EDIARY ENTRY. Protocol DeviationMissing Endpoint Assessments TREATMENT2020-08-12B,mRNA-1273-P201DVmRNA-1273-P201-US204-1114US2041114AP10.3 VISIT 4 (VACCINE 2) SHOULD HAVE OCCURRED NO LATER THAN 31JUL2020 Protocol DeviationVisit Scheduling TREATMENT2020-08-03B'mRNA-1273-P201DVmRNA-1273-P201-US204-1131US2041131AP10.3 VISIT 4 (VACCINE 2) SHOULD HAVE OCCURRED NO LATER THAN 03AUG2020 Protocol DeviationVisit Scheduling TREATMENT2020-08-10B+mRNA-1273-P201DVmRNA-1273-P201-US204-1132US2041132AP08_PROCEDURE NOT PERFORMED Protocol DeviationStudy Procedures/Assessments TREATMENT2020-08-13B1mRNA-1273-P201DVmRNA-1273-P201-US205-1001US2051001AI02.01_INCORRECT ICF SIGNED ICH/GCP Deviation ICF Process/Timing SCREENING2020-05-26mRNA-1273-P201DVmRNA-1273-P201-US205-1002US2051002AI02.01_INCORRECT ICF SIGNED ICH/GCP Deviation ICF Process/Timing SCREENING2020-05-26pmRNA-1273-P201DVmRNA-1273-P201-US205-1003US2051003AI02.01_INCORRECT ICF SIGNED ICH/GCP Deviation ICF Process/Timing SCREENING2020-05-260mRNA-1273-P201DVmRNA-1273-P201-US205-1003US2051003A P07_SUBJECT DIARY HAS 2 OR MORE DAYS OF SOLICITED ENTRIES MISSING Protocol DeviationMissing Endpoint Assessments TREATMENT2020-06-11AmRNA-1273-P201DVmRNA-1273-P201-US205-1003US2051003A0VACCINATION IS NOT ACCORDING TO THE PROTOCOL - DAY 1 VISIT DOSING PROCEDURE WAS NOT PERFORMED ACCORDING TO THE PHARMACY MANUAL AND DOSING WORKSHEET INSTRUCTION. Protocol DeviationStudy Treatment Admin/DispenseTREATMENT2020-05-29AmRNA-1273-P201DVmRNA-1273-P201-US205-1004US2051004AI02.01_INCORRECT ICF SIGNED ICH/GCP Deviation ICF Process/Timing SCREENING2020-05-26.mRNA-1273-P201DVmRNA-1273-P201-US205-1004US2051004A I02.01_RECONSENT NOT COLLECTED FOR NEW ICF ICH/GCP Deviation ICF Process/Timing SCREENING2020-06-11.mRNA-1273-P201DVmRNA-1273-P201-US205-1005US2051005AI02.01_INCORRECT ICF SIGNED ICH/GCP Deviation ICF Process/Timing SCREENING2020-05-26.mRNA-1273-P201DVmRNA-1273-P201-US205-1005US2051005A I02.01_RECONSENT NOT COLLECTED FOR NEW ICF ICH/GCP Deviation ICF Process/Timing SCREENING2020-06-11.mRNA-1273-P201DVmRNA-1273-P201-US205-1006US2051006AI02.01_INCORRECT ICF SIGNED ICH/GCP Deviation ICF Process/Timing SCREENING2020-05-26.mRNA-1273-P201DVmRNA-1273-P201-US205-1006US2051006A I02.01_RECONSENT NOT COLLECTED FOR NEW ICF ICH/GCP Deviation ICF Process/Timing SCREENING2020-06-11.mRNA-1273-P201DVmRNA-1273-P201-US205-1007US2051007AI02.01_RECONSENT NOT COLLECTED FOR NEW ICF ICH/GCP Deviation ICF Process/Timing SCREENING2020-06-11.mRNA-1273-P201DVmRNA-1273-P201-US205-1008US2051008AP07_SUBJECT DIARY HAS 2 OR MORE DAYS OF SOLICITED ENTRIES MISSING Protocol DeviationMissing Endpoint Assessments TREATMENT2020-06-11AmRNA-1273-P201DVmRNA-1273-P201-US205-1011US2051011AP10 VISIT 6 COMPLETED OOW Protocol DeviationVisit Scheduling TREATMENT2020-07-17B-mRNA-1273-P201DVmRNA-1273-P201-US205-1011US2051011A P10: (VISITS WHERE IMMUNOGENECITY SAMPLES ARE COLLECTED) Protocol DeviationVisit Scheduling FOLLOW-UP2020-07-30B:mRNA-1273-P201DVmRNA-1273-P201-US205-1012US2051012AP08_POST-DOSE VITAL SIGNS TIME IS PRIOR TO OR LESS THAN 60 MINUTES AFTER THE DOSE TIME. Protocol DeviationStudy Procedures/Assessments TREATMENT2020-06-02AmRNA-1273-P201DVmRNA-1273-P201-US205-1017US2051017AP10: (VISITS WHERE IMMUNOGENECITY SAMPLES ARE COLLECTED) Protocol DeviationVisit Scheduling FOLLOW-UP2020-07-29B7mRNA-1273-P201DVmRNA-1273-P201-US205-1022US2051022AP08_POST-DOSE VITAL SIGNS TIME IS PRIOR TO OR LESS THAN 60 MINUTES AFTER THE DOSE TIME. Protocol DeviationStudy Procedures/Assessments TREATMENT2020-06-03AmRNA-1273-P201DVmRNA-1273-P201-US205-1022US2051022A P10: (VISITS WHERE IMMUNOGENECITY SAMPLES ARE COLLECTED) Protocol DeviationVisit Scheduling FOLLOW-UP2020-07-29B9mRNA-1273-P201DVmRNA-1273-P201-US205-1024US2051024AP10: (VISITS WHERE IMMUNOGENECITY SAMPLES ARE COLLECTED) Protocol DeviationVisit Scheduling FOLLOW-UP2020-07-28B9mRNA-1273-P201DVmRNA-1273-P201-US205-1025US2051025AP10: (VISITS WHERE IMMUNOGENECITY SAMPLES ARE COLLECTED) Protocol DeviationVisit Scheduling FOLLOW-UP2020-07-30B8mRNA-1273-P201DVmRNA-1273-P201-US205-1026US2051026AP08_POST-DOSE VITAL SIGNS TIME IS PRIOR TO OR LESS THAN 60 MINUTES AFTER THE DOSE TIME. Protocol DeviationStudy Procedures/Assessments TREATMENT2020-06-02AmRNA-1273-P201DVmRNA-1273-P201-US205-1026US2051026A P08_PROCEDURE PERFORMED OUT OF WINDOW Protocol DeviationStudy Procedures/Assessments TREATMENT2020-06-25BmRNA-1273-P201DVmRNA-1273-P201-US205-1027US2051027AP10: (VISITS WHERE IMMUNOGENECITY SAMPLES ARE COLLECTED) Protocol DeviationVisit Scheduling FOLLOW-UP2020-07-31B6mRNA-1273-P201DVmRNA-1273-P201-US205-1028US2051028AP05.04_SUBJECT DID NOT COMPLY WITH STUDY VACCINATION SCHEDULE (2ND VACCINATION NOT GIVEN) Protocol DeviationStudy Treatment Admin/DispenseFOLLOW-UP2020-07-02BmRNA-1273-P201DVmRNA-1273-P201-US205-1029US2051029AP10: (VISITS WHERE IMMUNOGENECITY SAMPLES ARE COLLECTED) Protocol DeviationVisit Scheduling FOLLOW-UP2020-07-30B9mRNA-1273-P201DVmRNA-1273-P201-US205-1032US2051032AP08_POST-DOSE VITAL SIGNS TIME IS PRIOR TO OR LESS THAN 60 MINUTES AFTER THE DOSE TIME. Protocol DeviationStudy Procedures/Assessments TREATMENT2020-06-02AmRNA-1273-P201DVmRNA-1273-P201-US205-1032US2051032A P08_PROCEDURE PERFORMED OUT OF WINDOW Protocol DeviationStudy Procedures/Assessments TREATMENT2020-06-25BmRNA-1273-P201DVmRNA-1273-P201-US205-1033US2051033AP10 VISIT 6 COMPLETED OOW Protocol DeviationVisit Scheduling TREATMENT2020-07-17B,mRNA-1273-P201DVmRNA-1273-P201-US205-1033US2051033A P10: (VISITS WHERE IMMUNOGENECITY SAMPLES ARE COLLECTED) Protocol DeviationVisit Scheduling FOLLOW-UP2020-07-28B7mRNA-1273-P201DVmRNA-1273-P201-US205-1035US2051035AP10 VISIT 6 COMPLETED OOW Protocol DeviationVisit Scheduling TREATMENT2020-07-17B,mRNA-1273-P201DVmRNA-1273-P201-US205-1035US2051035A P10: (VISITS WHERE IMMUNOGENECITY SAMPLES ARE COLLECTED) Protocol DeviationVisit Scheduling FOLLOW-UP2020-07-30B9mRNA-1273-P201DVmRNA-1273-P201-US205-1042US2051042AP08_POST-DOSE VITAL SIGNS TIME IS PRIOR TO OR LESS THAN 60 MINUTES AFTER THE DOSE TIME. Protocol DeviationStudy Procedures/Assessments TREATMENT2020-06-02AmRNA-1273-P201DVmRNA-1273-P201-US205-1043US2051043AP07_SUBJECT DIARY NOT COMPLETED (IN ENTIRETY) FOR SAFETY DATA COLLECTION Protocol DeviationMissing Endpoint Assessments TREATMENT2020-06-11AmRNA-1273-P201DVmRNA-1273-P201-US205-1044US2051044AP10 VISIT 6 COMPLETED OOW Protocol DeviationVisit Scheduling TREATMENT2020-07-16B*mRNA-1273-P201DVmRNA-1273-P201-US205-1044US2051044A P10: (VISITS WHERE IMMUNOGENECITY SAMPLES ARE COLLECTED) Protocol DeviationVisit Scheduling FOLLOW-UP2020-07-28B6mRNA-1273-P201DVmRNA-1273-P201-US205-1059US2051059AP10: (VISITS WHERE IMMUNOGENECITY SAMPLES ARE COLLECTED) Protocol DeviationVisit Scheduling FOLLOW-UP2020-08-18B6mRNA-1273-P201DVmRNA-1273-P201-US205-1071US2051071AP09_ADMINISTRATION OF FORBIDDEN VACCINE OR MEDICATION Protocol DeviationConcomitant Medication FOLLOW-UP2020-08-24B9mRNA-1273-P201DVmRNA-1273-P201-US205-1072US2051072AP10_VISIT NOT PERFORMED Protocol DeviationVisit Scheduling TREATMENT2020-09-09BBmRNA-1273-P201DVmRNA-1273-P201-US205-1084US2051084AP09_ADMINISTRATION OF FORBIDDEN VACCINE OR MEDICATION Protocol DeviationConcomitant Medication TREATMENT2020-08-10B)mRNA-1273-P201DVmRNA-1273-P201-US205-1111US2051111AP10 VISIT 6 COMPLETED OOW Protocol DeviationVisit Scheduling TREATMENT2020-08-24B2mRNA-1273-P201DVmRNA-1273-P201-US206-1001US2061001AP07 D71 EDIARY NOT DONE. , SUBJECT NON COMPLIANT WITH SAFETY DIARY ENTRIES. SITE FAILED TO FOLLOW UP VIA TELEPHONE, NO DOCUMENTATION TO NOTE AT LEAST 2 ATTEMPTS MADE TO CONTACT SUBJECT. Protocol DeviationVisit Scheduling FOLLOW-UP2020-08-04B>mRNA-1273-P201DVmRNA-1273-P201-US206-1001US2061001A P10 VISIT 4 DATE IS > 35 DAYS AFTER DAY1 VISIT 1 VACCINATION Protocol DeviationVisit Scheduling TREATMENT2020-07-10B%mRNA-1273-P201DVmRNA-1273-P201-US206-1006US2061006A3JUL2020 THE SUBJECT MISSED DAYS 3 TO5 OF DIARY ENTRY AFTER VACCINATION #2 VISIT 4 . Protocol DeviationMissing Endpoint Assessments TREATMENT2020-07-03BmRNA-1273-P201DVmRNA-1273-P201-US206-1006US2061006A P10_V6D43 WAS OOW Protocol DeviationVisit Scheduling TREATMENT2020-07-22B2mRNA-1273-P201DVmRNA-1273-P201-US206-1008US2061008AP08-SUBJECT US2061008-REPORTED MILD UNDERARM GLAND SWELLING OR TENDERNESS ON THE SAME ARM AS THE INJECTION SITE ON DAY 2 (6/4/2020) IN THE EDIARY. THE SITE STAFF CONTACTED THE SUBJECT WITHIN 24 HOURSProtocol DeviationStudy Procedures/Assessments TREATMENT2020-06-04A mRNA-1273-P201DVmRNA-1273-P201-US206-1009US2061009AP07 D71 EDIARY ENTRY NOT COMPLETE, SUBJECT NON COMPLIANT WITH SAFETY DIARY ENTRIES. SITE FAILED TO FOLLOW UP VIA TELEPHONE, NO DOCUMENTATION TO NOTE AT LEAST 2 ATTEMPTS MADE TO CONTACT SUBJECT. Protocol DeviationVisit Scheduling FOLLOW-UP2020-08-04B?mRNA-1273-P201DVmRNA-1273-P201-US206-1010US2061010AP07 D71 EDIARY ENTRY NOT COMPLETE, SUBJECT NON COMPLIANT WITH SAFETY DIARY ENTRIES. SITE FAILED TO FOLLOW UP VIA TELEPHONE, NO DOCUMENTATION TO NOTE AT LEAST 2 ATTEMPTS MADE TO CONTACT SUBJECT. Protocol DeviationVisit Scheduling FOLLOW-UP2020-08-04B?mRNA-1273-P201DVmRNA-1273-P201-US206-1011US2061011AP07 D71 EDIARY ENTRY NOT COMPLETE, SUBJECT NON COMPLIANT WITH SAFETY DIARY ENTRIES. SITE FAILED TO FOLLOW UP VIA TELEPHONE, NO DOCUMENTATION TO NOTE AT LEAST 2 ATTEMPTS MADE TO CONTACT SUBJECT. Protocol DeviationVisit Scheduling FOLLOW-UP2020-08-10BEmRNA-1273-P201DVmRNA-1273-P201-US206-1019US2061019AP07 D71 EDIARY ENTRY NOT COMPLETE, SUBJECT NON COMPLIANT WITH SAFETY DIARY ENTRIES. SITE FAILED TO FOLLOW UP VIA TELEPHONE, NO DOCUMENTATION TO NOTE AT LEAST 2 ATTEMPTS MADE TO CONTACT SUBJECT. Protocol DeviationVisit Scheduling FOLLOW-UP2020-07-29B9mRNA-1273-P201DVmRNA-1273-P201-US206-1019US2061019A P10 V6 20JUL2020 IS +3 DAYS OUT OF WINDOW. Protocol DeviationVisit Scheduling TREATMENT2020-07-21B1mRNA-1273-P201DVmRNA-1273-P201-US206-1021US2061021A21JUL2020 VISIT 6 WAS +2 DAYS OUT OF WINDOW. Protocol DeviationVisit Scheduling TREATMENT2020-07-21B0mRNA-1273-P201DVmRNA-1273-P201-US206-1024US2061024AP07 D71 EDIARY ENTRY NOT COMPLETE, SUBJECT NON COMPLIANT WITH SAFETY DIARY ENTRIES. SITE FAILED TO FOLLOW UP VIA TELEPHONE, NO DOCUMENTATION TO NOTE AT LEAST 2 ATTEMPTS MADE TO CONTACT SUBJECT. Protocol DeviationVisit Scheduling FOLLOW-UP2020-08-04B?mRNA-1273-P201DVmRNA-1273-P201-US206-1024US2061024A V6 WAS OUT OF WINDOW + 3 DAYS OUT OF WINDOW. Protocol DeviationVisit Scheduling TREATMENT2020-07-22B2mRNA-1273-P201DVmRNA-1273-P201-US206-1024US2061024A0VACCINATION IS NOT ACCORDING TO THE PROTOCOL - SUBJECT WAS RANDOMIZED TO 100 MCG TREATMENT ARM AT DAY 1 BUT RECEIVED PLACEBO Protocol DeviationStudy Treatment Admin/DispenseTREATMENT2020-06-03AmRNA-1273-P201DVmRNA-1273-P201-US206-1025US2061025AVACCINATION IS NOT ACCORDING TO THE PROTOCOL - SUBJECT US206-1025 WAS RANDOMIZED TO PLACEBO TREATMENT ARM BUT RECEIVED 100 MCG DOSE AT DAY 1 Protocol DeviationStudy Treatment Admin/DispenseTREATMENT2020-06-03AmRNA-1273-P201DVmRNA-1273-P201-US206-1026US2061026AP07 D71 EDIARY ENTRY NOT COMPLETE, SUBJECT NON COMPLIANT WITH SAFETY DIARY ENTRIES. SITE FAILED TO FOLLOW UP VIA TELEPHONE, NO DOCUMENTATION TO NOTE AT LEAST 2 ATTEMPTS MADE TO CONTACT SUBJECT. Protocol DeviationVisit Scheduling FOLLOW-UP2020-08-04B=mRNA-1273-P201DVmRNA-1273-P201-US206-1032US2061032AP07 D71 EDIARY ENTRY NOT COMPLETE, SUBJECT NON COMPLIANT WITH SAFETY DIARY ENTRIES. SITE FAILED TO FOLLOW UP VIA TELEPHONE, NO DOCUMENTATION TO NOTE AT LEAST 2 ATTEMPTS MADE TO CONTACT SUBJECT. Protocol DeviationVisit Scheduling FOLLOW-UP2020-08-05B>mRNA-1273-P201DVmRNA-1273-P201-US206-1035US2061035AP10 23JUL2020(b)(6):SUBJECT US2061035 WAS VACCINATED WITH V4D29 (20JUL20) VACCINATION 24 DAYS AFTER THE FIRST TREATMENT (26JUN20) INSTEAD OF AT LEAST 28 DAYS BETWEEN VACCINATIONS. Protocol DeviationStudy Treatment Compliance TREATMENT2020-07-20BmRNA-1273-P201DVmRNA-1273-P201-US206-1045US2061045AP10_V7 DAY 57 WAS OOW Protocol DeviationVisit Scheduling FOLLOW-UP2020-08-20B5mRNA-1273-P201DVmRNA-1273-P201-US206-1051US2061051AP01 SUBJECT WAS NOT RECONSENTED TO V2.1_20200522 ICF AT THE NEXT SCHEDULED VISIT 30JUN2020 . Protocol DeviationInformed Consent TREATMENT2020-06-30AmRNA-1273-P201DVmRNA-1273-P201-US206-1063US2061063AP10_V6D43 WAS NOT DONE;(IMMUNOGENECITY SAMPLES WERE NOT COLLECTED). Protocol DeviationVisit Scheduling TREATMENT2020-08-11B+mRNA-1273-P201DVmRNA-1273-P201-US206-1067US2061067ASUBJECT US2061067 WAS CONSENTED BY LISA HEMMELGARN, WHO IS NOT ON THE DOA LOG. HOWEVER PROTOCOL TRAINING IS NOTED FOR MS. HEMMELGARN ON 22JUN2020. Protocol DeviationInformed Consent SCREENING2020-07-23.mRNA-1273-P201DVmRNA-1273-P201-US206-1068US2061068AP10 11AUG2020 V5 WAS +2 DAYS OUT OF WINDOW. Protocol DeviationVisit Scheduling TREATMENT2020-08-11B+mRNA-1273-P201DVmRNA-1273-P201-US206-1068US2061068A P10_V6D43 WAS NOT DONE;(IMMUNOGENECITY SAMPLES WERE NOT COLLECTED). Protocol DeviationVisit Scheduling TREATMENT2020-08-25B9mRNA-1273-P201DVmRNA-1273-P201-US207-1001US2071001ASOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE SYRINGE EXPIRATION TIME ON THE DOSE PREPARATION AND ADMINISTRATION WORKSHEET HAS NOT BEEN COMPLETED FOR VIAL 11328 (50 MCG). ICH/GCP Deviation Inv Record Keeping Source DocsTREATMENT2020-06-02APmRNA-1273-P201DVmRNA-1273-P201-US207-1002US2071002APROCEDURE NOT PERFORMED PHYSICAL EXAM Protocol DeviationStudy Procedures/Assessments FOLLOW-UP2020-07-27B9mRNA-1273-P201DVmRNA-1273-P201-US207-1002US2071002A PROCEDURE NOT PERFORMED VITAL SIGNS Protocol DeviationStudy Procedures/Assessments TREATMENT2020-07-21B3mRNA-1273-P201DVmRNA-1273-P201-US207-1002US2071002A0PROCEDURE NOT PERFORMED VITAL SIGNS Protocol DeviationStudy Procedures/Assessments FOLLOW-UP2020-07-27B9mRNA-1273-P201DVmRNA-1273-P201-US207-1002US2071002A@SOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE DOSE PREPARATION AND ADMINSTRATION WORKSHEET WERE NOT BEING FILLED OUT COMPLETELY. ICH/GCP Deviation Inv Record Keeping Source DocsTREATMENT2020-06-02A mRNA-1273-P201DVmRNA-1273-P201-US207-1003US2071003ASOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE DOSE PREPARATION AND ADMINSTRATION WORKSHEET WERE NOT BEING FILLED OUT COMPLETELY. ICH/GCP Deviation Inv Record Keeping Source DocsTREATMENT2020-06-02A mRNA-1273-P201DVmRNA-1273-P201-US207-1004US2071004ARECONSENT NOT COLLECTED FOR NEW ICF Protocol DeviationInformed Consent FOLLOW-UP2020-08-06B@mRNA-1273-P201DVmRNA-1273-P201-US207-1005US2071005ASOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE PLACEBO DOSE PREPARATION AND ADMINSTRATION WORKSHEET WAS COMPLETED INCORRECTLY. ICH/GCP Deviation Inv Record Keeping Source DocsTREATMENT2020-06-18BmRNA-1273-P201DVmRNA-1273-P201-US207-1006US2071006AP07: SUBJECT DIARY HAS 2 OR MORE DAYS OF SOLICITED ENTRIES MISSING Protocol DeviationMissing Endpoint Assessments TREATMENT2020-07-07B$mRNA-1273-P201DVmRNA-1273-P201-US207-1006US2071006A SOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE BPO DOSE NUMBER WAS NOT ENTERED CORRECTLY BY PI. ICH/GCP Deviation Inv Record Keeping Source DocsTREATMENT2020-06-02AmRNA-1273-P201DVmRNA-1273-P201-US207-1006US2071006A0SOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE DOSE PREPARATION AND ADMINSTRATION WORKSHEET WERE NOT BEING FILLED OUT COMPLETELY. ICH/GCP Deviation Inv Record Keeping Source DocsTREATMENT2020-06-02AmRNA-1273-P201DVmRNA-1273-P201-US207-1007US2071007ASOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE DOSE PREPARATION AND ADMINSTRATION WORKSHEET WERE NOT BEING FILLED OUT COMPLETELY. ICH/GCP Deviation Inv Record Keeping Source DocsTREATMENT2020-06-02AmRNA-1273-P201DVmRNA-1273-P201-US207-1012US2071012ARECONSENT NOT COLLECTED FOR NEW ICF Protocol DeviationInformed Consent FOLLOW-UP2020-08-05B@mRNA-1273-P201DVmRNA-1273-P201-US207-1013US2071013AP10.3 VISIT 4 (VACCINE 2) SHOULD HAVE OCCURRED NO LATER THAN 07JUL2020 Protocol DeviationVisit Scheduling TREATMENT2020-07-09B&mRNA-1273-P201DVmRNA-1273-P201-US207-1013US2071013A SOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE DOSE PREPARATION AND ADMINSTRATION WORKSHEET WERE NOT BEING FILLED OUT COMPLETELY. ICH/GCP Deviation Inv Record Keeping Source DocsTREATMENT2020-06-02AmRNA-1273-P201DVmRNA-1273-P201-US207-1016US2071016APROCEDURE NOT PERFORMED PHYSICAL EXAM Protocol DeviationStudy Procedures/Assessments FOLLOW-UP2020-08-03B>mRNA-1273-P201DVmRNA-1273-P201-US207-1016US2071016A PROCEDURE NOT PERFORMED VITAL SIGNS Protocol DeviationStudy Procedures/Assessments FOLLOW-UP2020-08-03B>mRNA-1273-P201DVmRNA-1273-P201-US207-1017US2071017ACRF ENTRY IS NOT SUPPORTED BY SOURCE DOCUMENTATION 24SEP: ROOT CAUSE ANALYSIS INDICATES THE MISSING SOURCE IS RELATED TO UNSUPERVISED SITE MANAGER REMOVING SOURCE DATA AND SUBJECT BINDERS IN ORDER TOICH/GCP Deviation Inv Record Keeping Source DocsTREATMENT2020-06-30BmRNA-1273-P201DVmRNA-1273-P201-US207-1017US2071017A EXCLUSION CRITERIA MET, BUT SUBJECT RANDOMIZED Protocol DeviationExclusion Criteria SCREENING2020-05-25mRNA-1273-P201DVmRNA-1273-P201-US207-1017US2071017A0VISIT NOT PERFORMED Protocol DeviationVisit Scheduling FOLLOW-UP2020-08-18BNmRNA-1273-P201DVmRNA-1273-P201-US207-1026US2071026ACRF ENTRY IS NOT SUPPORTED BY SOURCE DOCUMENTATION 24SEP: ROOT CAUSE ANALYSIS INDICATES THE MISSING SOURCE IS RELATED TO UNSUPERVISED SITE MANAGER REMOVING SOURCE DATA AND SUBJECT BINDERS IN ORDER TOICH/GCP Deviation Inv Record Keeping Source DocsTREATMENT2020-06-08AmRNA-1273-P201DVmRNA-1273-P201-US207-1029US2071029ACRF ENTRY IS NOT SUPPORTED BY SOURCE DOCUMENTATION 24SEP: ROOT CAUSE ANALYSIS INDICATES THE MISSING SOURCE IS RELATED TO UNSUPERVISED SITE MANAGER REMOVING SOURCE DATA AND SUBJECT BINDERS IN ORDER TOICH/GCP Deviation Inv Record Keeping Source DocsTREATMENT2020-06-12AmRNA-1273-P201DVmRNA-1273-P201-US207-1029US2071029A IMMUNOGENICITY RESULTS NOT AVAILABLE (ANTIBODY-MEDIATED IMMUNOGENICITY SAMPLES NOT COLLECTED AND PROCESSED AS OUTLINED IN LAB MANUAL) Protocol DeviationMissing Endpoint Assessments FOLLOW-UP2020-08-05B>mRNA-1273-P201DVmRNA-1273-P201-US207-1029US2071029A0MISSED DAY 71 DAIRY ENTRY Protocol DeviationVisit Scheduling FOLLOW-UP2020-08-05B>mRNA-1273-P201DVmRNA-1273-P201-US207-1029US2071029A@SOURCE DOCUMENTATION DOSE NOT MEET ALCOA - SITE DID NOT NOTE THE INJECTION SITE INFORMATION ON THE 50UG DOSE PREPARATION AND ADMINSTRATION WORKSHEET. ICH/GCP Deviation Inv Record Keeping Source DocsTREATMENT2020-06-18AmRNA-1273-P201DVmRNA-1273-P201-US207-1029US2071029APSOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE INJECTION TIME FOR UNBLINDED SUBJECT WAS NOTED TO BE MISSING ON THE DOSE PREPARATION AND ADMINSITRATION WORKSHEET. ICH/GCP Deviation Inv Record Keeping Source DocsTREATMENT2020-06-18AmRNA-1273-P201DVmRNA-1273-P201-US207-1029US2071029A`VACCINATION IS NOT ACCORDING TO THE PROTOCOL UNKNOWN ROUTE OF ADMIN; UNKNOWN IF IP WAS ACCEPTABLE FOR USE Protocol DeviationStudy Treatment Admin/DispenseTREATMENT2020-07-10B$mRNA-1273-P201DVmRNA-1273-P201-US207-1030US2071030ACRF ENTRY IS NOT SUPPORTED BY SOURCE DOCUMENTATION. 24SEP: ROOT CAUSE ANALYSIS INDICATES THE MISSING SOURCE IS RELATED TO UNSUPERVISED SITE MANAGER REMOVING SOURCE DATA AND SUBJECT BINDERS IN ORDER ICH/GCP Deviation Inv Record Keeping Source DocsTREATMENT2020-07-23B3mRNA-1273-P201DVmRNA-1273-P201-US207-1030US2071030A P10 VISIT PERFORMED OOW Protocol DeviationVisit Scheduling FOLLOW-UP2020-08-11BFmRNA-1273-P201DVmRNA-1273-P201-US207-1032US2071032ASOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE 50UG DOSE PREPARATION AND ADMINISTRATION WORKSHEET WAS COMPLETED INCORRECTLY. ICH/GCP Deviation Inv Record Keeping Source DocsTREATMENT2020-06-18AmRNA-1273-P201DVmRNA-1273-P201-US207-1033US2071033AP07: SUBJECT DIARY HAS 2 OR MORE DAYS OF SOLICITED ENTRIES MISSING Protocol DeviationMissing Endpoint Assessments TREATMENT2020-07-07BmRNA-1273-P201DVmRNA-1273-P201-US207-1033US2071033A VACCINATION IS NOT ACCORDING TO THE PROTOCOL UNKNOWN ROUTE OF ADMIN; UNKNOWN IF IP WAS ACCEPTABLE FOR USE Protocol DeviationStudy Treatment Admin/DispenseTREATMENT2020-07-09B mRNA-1273-P201DVmRNA-1273-P201-US207-1037US2071037ASOURCE DOCUMENTATION DOSE NOT MEET ALCOA - IP ACCOUNTABILITY LOG WAS MISSING ENTRY OF "DATE USED" ICH/GCP Deviation Inv Record Keeping Source DocsSCREENING2020-06-02mRNA-1273-P201DVmRNA-1273-P201-US207-1038US2071038AP05: SUBJECT RECEIVED VACCINE IN DIFFERENT ARMS ON DAY 1 AND DAY 29 Protocol DeviationStudy Treatment Admin/DispenseFOLLOW-UP2020-08-11BEmRNA-1273-P201DVmRNA-1273-P201-US207-1038US2071038A P10.3 VISIT 4 (VACCINE 2) SHOULD HAVE OCCURRED NO LATER THAN 09JUL2020 Protocol DeviationVisit Scheduling TREATMENT2020-07-13B(mRNA-1273-P201DVmRNA-1273-P201-US207-1038US2071038A0SOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE 100UG DOSE PREPARATION AND ADMINISTRATION WORKSHEET WAS COMPLETED INCORRECTLY. ICH/GCP Deviation Inv Record Keeping Source DocsTREATMENT2020-06-18AmRNA-1273-P201DVmRNA-1273-P201-US207-1038US2071038A@SOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE 100UG DOSE PREPARATION AND ADMINISTRATION WORKSHEET WAS COMPLETED INCORRECTLY. ICH/GCP Deviation Inv Record Keeping Source DocsTREATMENT2020-06-18AmRNA-1273-P201DVmRNA-1273-P201-US207-1039US2071039AP10.3 VISIT 4 (VACCINE 2) SHOULD HAVE OCCURRED NO LATER THAN 10JUL2020 Protocol DeviationVisit Scheduling TREATMENT2020-07-13B'mRNA-1273-P201DVmRNA-1273-P201-US207-1039US2071039A PROCEDURE NOT PERFORMED (NASOPHARYNGEAL SWAB COLLECTIONS AT D1) Protocol DeviationStudy Procedures/Assessments TREATMENT2020-06-05AmRNA-1273-P201DVmRNA-1273-P201-US207-1039US2071039A0SOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE 100UG DOSE PREPARATION AND ADMINISTRATION WORKSHEET WAS COMPLETED INCORRECTLY. ICH/GCP Deviation Inv Record Keeping Source DocsTREATMENT2020-06-18AmRNA-1273-P201DVmRNA-1273-P201-US207-1041US2071041ASOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE DOSE PREPARATION AND ADMINSTRATION WORKSHEET WAS COMPLETED INCORRECTLY. ICH/GCP Deviation Inv Record Keeping Source DocsTREATMENT2020-06-02AmRNA-1273-P201DVmRNA-1273-P201-US207-1041US2071041A SOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE DOSE PREPARATION AND ADMINSTRATION WORKSHEET WERE NOT BEING FILLED OUT COMPLETELY. ICH/GCP Deviation Inv Record Keeping Source DocsTREATMENT2020-06-02AmRNA-1273-P201DVmRNA-1273-P201-US207-1042US2071042AVISIT NOT PERFORMED Protocol DeviationVisit Scheduling TREATMENT2020-07-21B0mRNA-1273-P201DVmRNA-1273-P201-US207-1049US2071049ARECONSENT NOT COLLECTED FOR NEW ICF Protocol DeviationInformed Consent FOLLOW-UP2020-08-06B@mRNA-1273-P201DVmRNA-1273-P201-US207-1066US2071066APROCEDURE NOT PERFORMED PHYSICAL EXAM Protocol DeviationStudy Procedures/Assessments FOLLOW-UP2020-08-03B8mRNA-1273-P201DVmRNA-1273-P201-US207-1066US2071066A PROCEDURE NOT PERFORMED VITAL SIGNS Protocol DeviationStudy Procedures/Assessments FOLLOW-UP2020-08-03B8mRNA-1273-P201DVmRNA-1273-P201-US207-1067US2071067AP10 VISIT PERFORMED OOW Protocol DeviationVisit Scheduling FOLLOW-UP2020-08-13BFmRNA-1273-P201DVmRNA-1273-P201-US207-1068US2071068ASOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE 100UG DOSE PREPARATION AND ADMINISTRATION WORKSHEET WAS COMPLETED INCORRECTLY. ICH/GCP Deviation Inv Record Keeping Source DocsTREATMENT2020-06-18AmRNA-1273-P201DVmRNA-1273-P201-US207-1069US2071069ASOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE DOSE PREPARATION AND ADMINSTRATION WORKSHEET WAS NOT FILLED OUT COMPLETELY. ICH/GCP Deviation Inv Record Keeping Source DocsTREATMENT2020-06-18AmRNA-1273-P201DVmRNA-1273-P201-US207-1070US2071070AP07: SUBJECT DIARY HAS 2 OR MORE DAYS OF SOLICITED ENTRIES MISSING Protocol DeviationMissing Endpoint Assessments TREATMENT2020-06-15AmRNA-1273-P201DVmRNA-1273-P201-US207-1071US2071071ASUBJECT DOES NOT MEET ENTRY CRITERIA (EX#18) (EXCLUSION CRITERIA MET, BUT SUBJECT RANDOMIZED) Protocol DeviationExclusion Criteria TREATMENT2020-06-05AmRNA-1273-P201DVmRNA-1273-P201-US207-1073US2071073ASOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE DOSE PREPARATION AND ADMINSTRATION WORKSHEET WAS NOT FILLED OUT COMPLETELY. ICH/GCP Deviation Inv Record Keeping Source DocsTREATMENT2020-06-18AmRNA-1273-P201DVmRNA-1273-P201-US207-1074US2071074ASOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE 50UG DOSE PREPARATION AND ADMINISTRATION WORKSHEET WAS COMPLETED INCORRECTLY. ICH/GCP Deviation Inv Record Keeping Source DocsTREATMENT2020-06-18AmRNA-1273-P201DVmRNA-1273-P201-US207-1081US2071081ASOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE 50UG DOSE PREPARATION AND ADMINISTRATION WORKSHEET WAS NOT COMPLETED IN ITS ENTIRETY. ICH/GCP Deviation Inv Record Keeping Source DocsTREATMENT2020-06-18AmRNA-1273-P201DVmRNA-1273-P201-US207-1082US2071082ASOURCE DOCUMENTATION DOSE NOT MEET ALCOA - WORKSHEET "THAWING" SECTION NOT COMPLETED PROPERLY. ICH/GCP Deviation Inv Record Keeping Source DocsTREATMENT2020-08-12B0mRNA-1273-P201DVmRNA-1273-P201-US207-1083US2071083ASOURCE DOCUMENTATION DOSE NOT MEET ALCOA - BPO CONFIRMED BY INITIALS WERE MISSING IN THE DOSE PREPARATION WORKSHEET. ICH/GCP Deviation Inv Record Keeping Source DocsTREATMENT2020-08-12B0mRNA-1273-P201DVmRNA-1273-P201-US207-1083US2071083A SOURCE DOCUMENTATION DOSE NOT MEET ALCOA - VIAL EXPIRATION DATE NOT ADDED. ICH/GCP Deviation Inv Record Keeping Source DocsTREATMENT2020-08-12B0mRNA-1273-P201DVmRNA-1273-P201-US207-1083US2071083A0SOURCE DOCUMENTATION DOSE NOT MEET ALCOA - VIAL REGISTRATION IS MISSING FROM THE SUBJECT SOURCE. ICH/GCP Deviation Inv Record Keeping Source DocsTREATMENT2020-08-12B0mRNA-1273-P201DVmRNA-1273-P201-US207-1084US2071084ASOURCE DOCUMENTATION DOSE NOT MEET ALCOA - BPO FORM NOT COMPLETELY PROPERLY. ICH/GCP Deviation Inv Record Keeping Source DocsTREATMENT2020-08-14B2mRNA-1273-P201DVmRNA-1273-P201-US207-1086US2071086ACRF ENTRY IS NOT SUPPORTED BY SOURCE DOCUMENTATION 24SEP: ROOT CAUSE ANALYSIS INDICATES THE MISSING SOURCE IS RELATED TO UNSUPERVISED SITE MANAGER REMOVING SOURCE DATA AND SUBJECT BINDERS IN ORDER TOICH/GCP Deviation Inv Record Keeping Source DocsTREATMENT2020-07-09AmRNA-1273-P201DVmRNA-1273-P201-US207-1086US2071086A SOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE DOSE PREPARATION AND ADMINSTRATION WORKSHEET WAS NOT FILLED OUT COMPLETELY. ICH/GCP Deviation Inv Record Keeping Source DocsTREATMENT2020-08-14B2mRNA-1273-P201DVmRNA-1273-P201-US207-1087US2071087ASOURCE DOCUMENTATION DOSE NOT MEET ALCOA - US2071087/US2071082 - WORKSHEET PAGE 1 NOT COMPLETED PROPERLY. ICH/GCP Deviation Inv Record Keeping Source DocsTREATMENT2020-08-12B0mRNA-1273-P201DVmRNA-1273-P201-US207-1087US2071087A SUBJECT DIARY HAS 2 OR MORE CONSECUTIVE DAYS OF SOLICITED ENTRIES MISSING Protocol DeviationMissing Endpoint Assessments TREATMENT2020-07-06AmRNA-1273-P201DVmRNA-1273-P201-US207-1088US2071088ASOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE DOSE PREPARATION AND ADMINSTRATION WORKSHEET WAS NOT FILLED OUT COMPLETELY ICH/GCP Deviation Inv Record Keeping Source DocsTREATMENT2020-08-14B2mRNA-1273-P201DVmRNA-1273-P201-US207-1089US2071089ASOURCE DOCUMENTATION DOSE NOT MEET ALCOA - VIAL REGISTRATION IS MISSING FROM THE SUBJECT SOURCE. ICH/GCP Deviation Inv Record Keeping Source DocsTREATMENT2020-08-12B0mRNA-1273-P201DVmRNA-1273-P201-US207-1090US2071090ASOURCE DOCUMENTATION DOSE NOT MEET ALCOA - VIAL REGISTRATION IS MISSING FROM THE SUBJECT SOURCE. ICH/GCP Deviation Inv Record Keeping Source DocsTREATMENT2020-08-12B-mRNA-1273-P201DVmRNA-1273-P201-US207-1091US2071091ASOURCE DOCUMENTATION DOSE NOT MEET ALCOA - VIAL REGISTRATION IS MISSING FROM THE SUBJECT SOURCE. ICH/GCP Deviation Inv Record Keeping Source DocsTREATMENT2020-08-12B0mRNA-1273-P201DVmRNA-1273-P201-US207-1092US2071092AP02: SUBJECT 2071092 SCREENING BMI WAS 31.5 BUT RANDOMIZED TO TRIAL. PER SITE, THEY ARE UNSURE IF COLLECTION OF INCORRECT HEIGHT AT SCREENING VISIT WAS DUE TO SUBJECT HIGH HEEL SHOES OR BAD Protocol DeviationInclusion Criteria SCREENING2020-06-19pmRNA-1273-P201DVmRNA-1273-P201-US207-1092US2071092A SOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE DOSE PREPARATION AND ADMINSTRATION WORKSHEET WAS NOT FILLED OUT COMPLETELY. ICH/GCP Deviation Inv Record Keeping Source DocsTREATMENT2020-08-14B2mRNA-1273-P201DVmRNA-1273-P201-US207-1093US2071093ASUBJECT DIARY HAS 2 OR MORE DAYS OF SOLICITED ENTRIES MISSING Protocol DeviationMissing Endpoint Assessments TREATMENT2020-06-29AmRNA-1273-P201DVmRNA-1273-P201-US207-1094US2071094APROCEDURE NOT PERFORMED Protocol DeviationStudy Procedures/Assessments TREATMENT2020-08-04BmRNA-1273-P201DVmRNA-1273-P201-US207-1094US2071094A PROCEDURE NOT PERFORMED (EXCLUDING IMMUNOGENICITY BLOOD DRAWS AND VACCINATIONS) Protocol DeviationStudy Procedures/Assessments TREATMENT2020-08-04BmRNA-1273-P201DVmRNA-1273-P201-US207-1096US2071096ASUBJECT DOES NOT MEET ENTRY CRITERIA (EX#18) (EXCLUSION CRITERIA MET, BUT SUBJECT RANDOMIZED) Protocol DeviationExclusion Criteria SCREENING2020-06-24mRNA-1273-P201DVmRNA-1273-P201-US207-1096US2071096A VISIT4 2ND VACCINE COMPLETED BY (b)(6) BUT SOURCE DOCUMENTS FOR THE VISIT WAS NOT FULLY COMPLETED. ICH/GCP Deviation Inv Record Keeping Source DocsTREATMENT2020-08-05B#mRNA-1273-P201DVmRNA-1273-P201-US207-1098US2071098AEXCLUSION CRITERIA MET, BUT SUBJECT RANDOMIZED Protocol DeviationExclusion Criteria TREATMENT2020-08-24B7mRNA-1273-P201DVmRNA-1273-P201-US207-1098US2071098A SOURCE DOCUMENTATION DOSE NOT MEET ALCOA - BPO DOCUMENT HAS DOSE 2 NOT MARKED. ICH/GCP Deviation Inv Record Keeping Source DocsTREATMENT2020-08-14B-mRNA-1273-P201DVmRNA-1273-P201-US207-1098US2071098A0VISIT4 2ND VACCINE COMPLETED BY (b)(6) BUT SOURCE DOCUMENTS FOR THE VISIT WAS NOT FULLY COMPLETED. ICH/GCP Deviation Inv Record Keeping Source DocsTREATMENT2020-08-05B$mRNA-1273-P201DVmRNA-1273-P201-US207-1099US2071099ASOURCE DOCUMENTATION DOSE NOT MEET ALCOA - EXPIRATION DATE MISSING FOR THE NACL ICH/GCP Deviation Inv Record Keeping Source DocsTREATMENT2020-08-12B%mRNA-1273-P201DVmRNA-1273-P201-US207-1099US2071099A SUBJECT DIARY NOT COMPLETED (IN ENTIRETY) FOR SAFETY DATA COLLECTION Protocol DeviationMissing Endpoint Assessments TREATMENT2020-08-11B$mRNA-1273-P201DVmRNA-1273-P201-US207-1099US2071099A0SUBJECT DOES NOT MEET ENTRY CRITERIA (EX#18) (EXCLUSION CRITERIA MET, BUT SUBJECT RANDOMIZED) Protocol DeviationExclusion Criteria TREATMENT2020-07-07AmRNA-1273-P201DVmRNA-1273-P201-US207-1099US2071099A@VACCINATION IS NOT ACCORDING TO THE PROTOCOL IP GIVEN THAT WAS NOT APPROPRIATE FOR USE (IMPACTED BY UNREPORTED TEMPERATURE DEVIATION, ETC., INCORRECT LOCATION OF ADMINISTRATION, OR OTHER Protocol DeviationStudy Treatment Admin/DispenseTREATMENT2020-08-04BmRNA-1273-P201DVmRNA-1273-P201-US207-1101US2071101AEXCLUSION CRITERIA MET, BUT SUBJECT RANDOMIZED Protocol DeviationExclusion Criteria TREATMENT2020-08-24B9mRNA-1273-P201DVmRNA-1273-P201-US207-1101US2071101A VACCINATION IS NOT ACCORDING TO THE PROTOCOL UNKNOWN ROUTE OF ADMIN; UNKNOWN IF IP WAS ACCEPTABLE FOR USE Protocol DeviationStudy Treatment Admin/DispenseTREATMENT2020-08-31B@mRNA-1273-P201DVmRNA-1273-P201-US207-1103US2071103AP10 VISIT PERFORMED OOW Protocol DeviationVisit Scheduling FOLLOW-UP2020-09-11BHmRNA-1273-P201DVmRNA-1273-P201-US208-1001US2081001ASOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE SYRINGE EXPIRATION TIME ON THE DOSE PREPARATION AND ADMINISTRATION WORKSHEET HAS NOT BEEN COMPLETED FOR VIALS 11320 AND 11319 (100 MCG). ICH/GCP Deviation Inv Record Keeping Source DocsTREATMENT2020-05-29AmRNA-1273-P201DVmRNA-1273-P201-US208-1002US2081002ASOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE SYRINGE EXPIRATION TIME ON THE DOSE PREPARATION AND ADMINISTRATION WORKSHEET HAS NOT BEEN COMPLETED FOR VIALS 11317 AND 11318 (100 MCG). ICH/GCP Deviation Inv Record Keeping Source DocsTREATMENT2020-05-29AmRNA-1273-P201DVmRNA-1273-P201-US208-1003US2081003AP05: SUBJECT RECEIVED VACCINE IN DIFFERENT ARMS ON DAY 1 AND DAY 29 Protocol DeviationStudy Treatment Admin/DispenseFOLLOW-UP2020-07-27B<mRNA-1273-P201DVmRNA-1273-P201-US208-1003US2081003A SOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE SYRINGE EXPIRATION TIME ON THE DOSE PREPARATION AND ADMINISTRATION WORKSHEET HAS NOT BEEN COMPLETED FOR VIAL 11312 (50 MCG). ICH/GCP Deviation Inv Record Keeping Source DocsTREATMENT2020-05-29AmRNA-1273-P201DVmRNA-1273-P201-US208-1003US2081003A0SUBJECT DIARY HAS 2 OR MORE DAYS OF SOLICITED ENTRIES MISSING Protocol DeviationMissing Endpoint Assessments TREATMENT2020-06-11AmRNA-1273-P201DVmRNA-1273-P201-US208-1005US2081005APROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS) Protocol DeviationStudy Procedures/Assessments TREATMENT2020-06-01AmRNA-1273-P201DVmRNA-1273-P201-US208-1009US2081009APROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS) Protocol DeviationStudy Procedures/Assessments TREATMENT2020-06-15AmRNA-1273-P201DVmRNA-1273-P201-US208-1009US2081009A SOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE SYRINGE EXPIRATION TIME ON THE DOSE PREPARATION AND ADMINISTRATION WORKSHEET HAS NOT BEEN COMPLETED FOR VIAL 11313 (50 MCG). ICH/GCP Deviation Inv Record Keeping Source DocsTREATMENT2020-06-01AmRNA-1273-P201DVmRNA-1273-P201-US208-1014US2081014APROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS) Protocol DeviationStudy Procedures/Assessments TREATMENT2020-06-15AmRNA-1273-P201DVmRNA-1273-P201-US208-1014US2081014A SOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE SYRINGE EXPIRATION TIME ON THE DOSE PREPARATION AND ADMINISTRATION WORKSHEET HAS NOT BEEN COMPLETED FOR VIALS 11316 AND 11322 (100 MCG). ICH/GCP Deviation Inv Record Keeping Source DocsTREATMENT2020-06-01AmRNA-1273-P201DVmRNA-1273-P201-US208-1015US2081015ALAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL. (EXPIRED TUBES, AMBIENT SHIPMENT, INCORRECT LAB KIT USED) Protocol DeviationStudy Procedures/Assessments TREATMENT2020-07-01BmRNA-1273-P201DVmRNA-1273-P201-US208-1015US2081015A PROCEDURE NOT PERFORMED (EXCLUDING IMMUNOGENICITY BLOOD DRAWS AND VACCINATIONS) (NASOPHARYNGEAL SWAB COLLECTIONS AT D1, D29, D57, UNS, MAAE) Protocol DeviationStudy Procedures/Assessments TREATMENT2020-06-01AmRNA-1273-P201DVmRNA-1273-P201-US208-1016US2081016ASOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE SYRINGE EXPIRATION TIME ON THE DOSE PREPARATION AND ADMINISTRATION WORKSHEET HAS NOT BEEN COMPLETED FOR VIALS 11314 AND 11315 (100 MCG). ICH/GCP Deviation Inv Record Keeping Source DocsTREATMENT2020-06-01AmRNA-1273-P201DVmRNA-1273-P201-US208-1016US2081016A SUBJECT DIARY HAS 2 OR MORE DAYS OF SOLICITED ENTRIES MISSING Protocol DeviationMissing Endpoint Assessments TREATMENT2020-06-11AmRNA-1273-P201DVmRNA-1273-P201-US208-1016US2081016A0SUBJECT DOES NOT MEET ENTRY CRITERIA (EX#18) (EXCLUSION CRITERIA MET, BUT SUBJECT RANDOMIZED) Protocol DeviationExclusion Criteria SCREENING2020-05-27PmRNA-1273-P201DVmRNA-1273-P201-US208-1017US2081017APROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS) Protocol DeviationStudy Procedures/Assessments SCREENING2020-05-28PmRNA-1273-P201DVmRNA-1273-P201-US208-1017US2081017A PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS) Protocol DeviationStudy Procedures/Assessments TREATMENT2020-06-02AmRNA-1273-P201DVmRNA-1273-P201-US208-1019US2081019APROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS) Protocol DeviationStudy Procedures/Assessments TREATMENT2020-06-02AmRNA-1273-P201DVmRNA-1273-P201-US208-1019US2081019A SOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE SYRINGE EXPIRATION TIME ON THE DOSE PREPARATION AND ADMINISTRATION WORKSHEET HAS NOT BEEN COMPLETED FOR VIALS 11329 AND 11330 (100 MCG). ICH/GCP Deviation Inv Record Keeping Source DocsTREATMENT2020-06-02AmRNA-1273-P201DVmRNA-1273-P201-US208-1019US2081019A0VISIT COMPLETED OUT OF WINDOW (EXCLUDING DOSING VISITS) Protocol DeviationVisit Scheduling TREATMENT2020-06-08ApmRNA-1273-P201DVmRNA-1273-P201-US208-1023US2081023ALAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL. (EXPIRED TUBES, AMBIENT SHIPMENT, INCORRECT LAB KIT USED) Protocol DeviationStudy Procedures/Assessments TREATMENT2020-07-07B#mRNA-1273-P201DVmRNA-1273-P201-US208-1023US2081023A PROCEDURE NOT PERFORMED (EXCLUDING IMMUNOGENICITY BLOOD DRAWS AND VACCINATIONS) (NASOPHARYNGEAL SWAB COLLECTIONS AT D1, D29, D57, UNS, MAAE) Protocol DeviationStudy Procedures/Assessments TREATMENT2020-07-08B$mRNA-1273-P201DVmRNA-1273-P201-US208-1023US2081023A0SUBJECT DIARY HAS 2 OR MORE DAYS OF SOLICITED ENTRIES MISSING Protocol DeviationMissing Endpoint Assessments TREATMENT2020-06-11AmRNA-1273-P201DVmRNA-1273-P201-US208-1023US2081023A@VISIT COMPLETED OUT OF WINDOW (EXCLUDING DOSING VISITS) Protocol DeviationStudy Procedures/Assessments TREATMENT2020-07-08B$mRNA-1273-P201DVmRNA-1273-P201-US208-1025US2081025ALAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL. (EXPIRED TUBES, AMBIENT SHIPMENT, INCORRECT LAB KIT USED) Protocol DeviationStudy Procedures/Assessments TREATMENT2020-07-07B#mRNA-1273-P201DVmRNA-1273-P201-US208-1026US2081026ALAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL. (EXPIRED TUBES, AMBIENT SHIPMENT, INCORRECT LAB KIT USED) Protocol DeviationStudy Procedures/Assessments TREATMENT2020-07-07B"mRNA-1273-P201DVmRNA-1273-P201-US208-1028US2081028ALAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL. (EXPIRED TUBES, AMBIENT SHIPMENT, INCORRECT LAB KIT USED) Protocol DeviationStudy Procedures/Assessments TREATMENT2020-07-07B$mRNA-1273-P201DVmRNA-1273-P201-US208-1028US2081028A PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS) Protocol DeviationStudy Procedures/Assessments TREATMENT2020-06-02AmRNA-1273-P201DVmRNA-1273-P201-US208-1028US2081028A0PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS) (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments TREATMENT2020-06-02AmRNA-1273-P201DVmRNA-1273-P201-US208-1028US2081028A@SOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE SYRINGE EXPIRATION TIME ON THE DOSE PREPARATION AND ADMINISTRATION WORKSHEET HAS NOT BEEN COMPLETED FOR VIALS 11323 AND 11324 (100 MCG). ICH/GCP Deviation Inv Record Keeping Source DocsTREATMENT2020-06-02AmRNA-1273-P201DVmRNA-1273-P201-US208-1028US2081028APVISIT COMPLETED OUT OF WINDOW (EXCLUDING DOSING VISITS) Protocol DeviationVisit Scheduling TREATMENT2020-06-08ApmRNA-1273-P201DVmRNA-1273-P201-US208-1033US2081033ALAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL. (EXPIRED TUBES, AMBIENT SHIPMENT, INCORRECT LAB KIT USED) Protocol DeviationStudy Procedures/Assessments TREATMENT2020-07-07B$mRNA-1273-P201DVmRNA-1273-P201-US208-1033US2081033A PROCEDURE NOT PERFORMED (EXCLUDING IMMUNOGENICITY BLOOD DRAWS AND VACCINATIONS) (NASOPHARYNGEAL SWAB COLLECTIONS AT D1, D29, D57, UNS, MAAE) Protocol DeviationStudy Procedures/Assessments SCREENING2020-05-29@mRNA-1273-P201DVmRNA-1273-P201-US208-1033US2081033A0PROCEDURE NOT PERFORMED (EXCLUDING IMMUNOGENICITY BLOOD DRAWS AND VACCINATIONS) (NASOPHARYNGEAL SWAB COLLECTIONS AT D1, D29, D57, UNS, MAAE) Protocol DeviationStudy Procedures/Assessments TREATMENT2020-06-02AmRNA-1273-P201DVmRNA-1273-P201-US208-1033US2081033A@SUBJECT DIARY HAS 2 OR MORE DAYS OF SOLICITED ENTRIES MISSING Protocol DeviationMissing Endpoint Assessments TREATMENT2020-07-14B+mRNA-1273-P201DVmRNA-1273-P201-US208-1035US2081035ASOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE SYRINGE EXPIRATION TIME ON THE DOSE PREPARATION AND ADMINISTRATION WORKSHEET HAS NOT BEEN COMPLETED FOR VIALS 11332 AND 11331 (100 MCG). ICH/GCP Deviation Inv Record Keeping Source DocsTREATMENT2020-06-02AmRNA-1273-P201DVmRNA-1273-P201-US208-1035US2081035A VISIT COMPLETED OUT OF WINDOW (EXCLUDING DOSING VISITS) Protocol DeviationVisit Scheduling TREATMENT2020-06-08ApmRNA-1273-P201DVmRNA-1273-P201-US208-1036US2081036ASUBJECT DIARY HAS 2 OR MORE DAYS OF SOLICITED ENTRIES MISSING Protocol DeviationMissing Endpoint Assessments TREATMENT2020-07-15B*mRNA-1273-P201DVmRNA-1273-P201-US208-1038US2081038AP05: SUBJECT RECEIVED VACCINE IN DIFFERENT ARMS ON DAY 1 AND DAY 29 Protocol DeviationStudy Treatment Admin/DispenseFOLLOW-UP2020-08-10B@mRNA-1273-P201DVmRNA-1273-P201-US208-1039US2081039ALAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL. (EXPIRED TUBES, AMBIENT SHIPMENT, INCORRECT LAB KIT USED) Protocol DeviationStudy Procedures/Assessments TREATMENT2020-07-08BmRNA-1273-P201DVmRNA-1273-P201-US208-1039US2081039A VISIT COMPLETED OUT OF WINDOW (VISITS WHERE IMMUNOGENECITY SAMPLES ARE COLLECTED) Protocol DeviationVisit Scheduling TREATMENT2020-06-26BmRNA-1273-P201DVmRNA-1273-P201-US208-1041US2081041ALAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL. (EXPIRED TUBES, AMBIENT SHIPMENT, INCORRECT LAB KIT USED) Protocol DeviationStudy Procedures/Assessments TREATMENT2020-07-07B"mRNA-1273-P201DVmRNA-1273-P201-US208-1041US2081041A PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS) Protocol DeviationStudy Procedures/Assessments TREATMENT2020-06-04AmRNA-1273-P201DVmRNA-1273-P201-US208-1042US2081042ALAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL. (EXPIRED TUBES, AMBIENT SHIPMENT, INCORRECT LAB KIT USED) Protocol DeviationStudy Procedures/Assessments TREATMENT2020-07-08BmRNA-1273-P201DVmRNA-1273-P201-US208-1045US2081045ALAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL. (EXPIRED TUBES, AMBIENT SHIPMENT, INCORRECT LAB KIT USED) Protocol DeviationStudy Procedures/Assessments TREATMENT2020-07-07B"mRNA-1273-P201DVmRNA-1273-P201-US208-1045US2081045A SUBJECT DIARY HAS 2 OR MORE DAYS OF SOLICITED ENTRIES MISSING Protocol DeviationMissing Endpoint Assessments TREATMENT2020-06-11AmRNA-1273-P201DVmRNA-1273-P201-US208-1045US2081045A0SUBJECT DIARY HAS 2 OR MORE DAYS OF SOLICITED ENTRIES MISSING Protocol DeviationMissing Endpoint Assessments TREATMENT2020-07-14B)mRNA-1273-P201DVmRNA-1273-P201-US208-1045US2081045A@SUBJECT DOES NOT MEET ENTRY CRITERIA (EX#18) (EXCLUSION CRITERIA MET, BUT SUBJECT RANDOMIZED) Protocol DeviationExclusion Criteria SCREENING2020-06-010mRNA-1273-P201DVmRNA-1273-P201-US208-1049US2081049ALAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL. (EXPIRED TUBES, AMBIENT SHIPMENT, INCORRECT LAB KIT USED) Protocol DeviationStudy Procedures/Assessments TREATMENT2020-07-08BmRNA-1273-P201DVmRNA-1273-P201-US208-1051US2081051ALAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL. (EXPIRED TUBES, AMBIENT SHIPMENT, INCORRECT LAB KIT USED) Protocol DeviationStudy Procedures/Assessments TREATMENT2020-07-08B"mRNA-1273-P201DVmRNA-1273-P201-US208-1051US2081051A PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS) (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments TREATMENT2020-07-08B"mRNA-1273-P201DVmRNA-1273-P201-US208-1051US2081051A0VISIT COMPLETED OUT OF WINDOW (EXCLUDING DOSING VISITS) Protocol DeviationVisit Scheduling TREATMENT2020-07-14B(mRNA-1273-P201DVmRNA-1273-P201-US208-1054US2081054ALAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL. (EXPIRED TUBES, AMBIENT SHIPMENT, INCORRECT LAB KIT USED) Protocol DeviationStudy Procedures/Assessments TREATMENT2020-06-22BmRNA-1273-P201DVmRNA-1273-P201-US208-1054US2081054A LAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL. (EXPIRED TUBES, AMBIENT SHIPMENT, INCORRECT LAB KIT USED) Protocol DeviationStudy Procedures/Assessments TREATMENT2020-07-08B"mRNA-1273-P201DVmRNA-1273-P201-US208-1058US2081058AIMMUNOGENICITY RESULTS NOT AVAILABLE (ANTIBODY-MEDIATED IMMUNOGENICITY SAMPLES NOT COLLECTED) Protocol DeviationMissing Endpoint Assessments FOLLOW-UP2020-06-22AmRNA-1273-P201DVmRNA-1273-P201-US208-1058US2081058A PROCEDURE NOT PERFORMED (EXCLUDING IMMUNOGENICITY BLOOD DRAWS AND VACCINATIONS) (NASOPHARYNGEAL SWAB COLLECTIONS AT D1, D29, D57, UNS, MAAE) Protocol DeviationStudy Procedures/Assessments FOLLOW-UP2020-07-14B%mRNA-1273-P201DVmRNA-1273-P201-US208-1058US2081058A0SUBJECT DID NOT COMPLY WITH STUDY VACCINATION SCHEDULE (2ND VACCINATION NOT GIVEN ) Protocol DeviationStudy Treatment Admin/DispenseFOLLOW-UP2020-07-06BmRNA-1273-P201DVmRNA-1273-P201-US208-1058US2081058A@VISIT 3/DAY 15 CONDUCTED VIA PHONE DUE TO COVID-19 IMPACT AND VITAL SIGNS/PHYSICAL EXAM, ANTIBODY-MEDIATED IMMUNOGENICITY WERE NOT COMPLETED Protocol DeviationStudy Procedures/Assessments FOLLOW-UP2020-06-22AmRNA-1273-P201DVmRNA-1273-P201-US208-1063US2081063ALAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL. (EXPIRED TUBES, AMBIENT SHIPMENT, INCORRECT LAB KIT USED) Protocol DeviationStudy Procedures/Assessments TREATMENT2020-07-08BmRNA-1273-P201DVmRNA-1273-P201-US208-1064US2081064APROCEDURE NOT PERFORMED (EXCLUDING IMMUNOGENICITY BLOOD DRAWS AND VACCINATIONS) (NASOPHARYNGEAL SWAB COLLECTIONS AT D1, D29, D57, UNS, MAAE) Protocol DeviationStudy Procedures/Assessments TREATMENT2020-07-10B!mRNA-1273-P201DVmRNA-1273-P201-US208-1065US2081065AICF NOT SIGNED OR INCORRECT ICF SIGNED OR ICF NOT SIGNED AND DATED BY SUBJECT, LAR AND INVESTIGATOR OR SIGNED AFTER COMMENCING STUDY PROCEDURES; RECONSENT NOT COLLECTED FOR NEW ICF; DEVIATION ICH/GCP Deviation ICF Process/Timing FOLLOW-UP2020-08-24B<mRNA-1273-P201DVmRNA-1273-P201-US208-1066US2081066AICF NOT SIGNED OR INCORRECT ICF SIGNED OR ICF NOT SIGNED AND DATED BY SUBJECT, LAR AND INVESTIGATOR OR SIGNED AFTER COMMENCING STUDY PROCEDURES; RECONSENT NOT COLLECTED FOR NEW ICF; DEVIATION ICH/GCP Deviation ICF Process/Timing FOLLOW-UP2020-08-25B=mRNA-1273-P201DVmRNA-1273-P201-US208-1066US2081066A VISIT COMPLETED OUT OF WINDOW (EXCLUDING DOSING VISITS) Protocol DeviationVisit Scheduling TREATMENT2020-08-11B/mRNA-1273-P201DVmRNA-1273-P201-US208-1069US2081069AP08_POST-DOSE VITAL SIGNS TIME IS PRIOR TO OR LESS THAN 60 MINUTES AFTER THE DOSE TIME Protocol DeviationStudy Procedures/Assessments TREATMENT2020-07-24BmRNA-1273-P201DVmRNA-1273-P201-US208-1076US2081076APROCEDURE NOT PERFORMED (EXCLUDING IMMUNOGENICITY BLOOD DRAWS AND VACCINATIONS) (NASOPHARYNGEAL SWAB COLLECTIONS AT D1, D29, D57, UNS, MAAE) Protocol DeviationStudy Procedures/Assessments TREATMENT2020-07-01AmRNA-1273-P201DVmRNA-1273-P201-US208-1080US2081080AICF INCORRRECTLY SIGNED OR DATED BY SUBJECT, LAR AND/OR INVESTIGATOR; ICF RECONSENT NOT COLLECTED AT THE NEXT SCHEDULED VISIT, RECONSENT OBTAINED AT A LATER VISIT; DEVIATION DID NOT RESULT IN AN Protocol DeviationInformed Consent FOLLOW-UP2020-08-28B;mRNA-1273-P201DVmRNA-1273-P201-US208-1081US2081081AICF NOT SIGNED OR INCORRECT ICF SIGNED OR ICF NOT SIGNED AND DATED BY SUBJECT, LAR AND INVESTIGATOR OR SIGNED AFTER COMMENCING STUDY PROCEDURES; RECONSENT NOT COLLECTED FOR NEW ICF; DEVIATION ICH/GCP Deviation ICF Process/Timing FOLLOW-UP2020-08-27B<mRNA-1273-P201DVmRNA-1273-P201-US208-1085US2081085AICF NOT SIGNED OR INCORRECT ICF SIGNED OR ICF NOT SIGNED AND DATED BY SUBJECT, LAR AND INVESTIGATOR OR SIGNED AFTER COMMENCING STUDY PROCEDURES; RECONSENT NOT COLLECTED FOR NEW ICF; DEVIATION ICH/GCP Deviation ICF Process/Timing TREATMENT2020-08-26B7mRNA-1273-P201DVmRNA-1273-P201-US208-1085US2081085A VISIT COMPLETED OUT OF WINDOW (VISITS WHERE IMMUNOGENECITY SAMPLES ARE COLLECTED) Protocol DeviationVisit Scheduling TREATMENT2020-08-11B(mRNA-1273-P201DVmRNA-1273-P201-US208-1088US2081088AICF INCORRRECTLY SIGNED OR DATED BY SUBJECT, LAR AND/OR INVESTIGATOR; ICF RECONSENT NOT COLLECTED AT THE NEXT SCHEDULED VISIT, RECONSENT OBTAINED AT A LATER VISIT; DEVIATION DID NOT RESULT IN AN Protocol DeviationInformed Consent FOLLOW-UP2020-08-31B=mRNA-1273-P201DVmRNA-1273-P201-US208-1092US2081092AICF INCORRRECTLY SIGNED OR DATED BY SUBJECT, LAR AND/OR INVESTIGATOR; ICF RECONSENT NOT COLLECTED AT THE NEXT SCHEDULED VISIT, RECONSENT OBTAINED AT A LATER VISIT; DEVIATION DID NOT RESULT IN AN Protocol DeviationInformed Consent FOLLOW-UP2020-08-28B:mRNA-1273-P201DVmRNA-1273-P201-US208-1092US2081092A VISIT COMPLETED OUT OF WINDOW (EXCLUDING DOSING VISITS) Protocol DeviationVisit Scheduling TREATMENT2020-08-06B$mRNA-1273-P201DVmRNA-1273-P201-US208-1097US2081097AICF INCORRRECTLY SIGNED OR DATED BY SUBJECT, LAR AND/OR INVESTIGATOR; ICF RECONSENT NOT COLLECTED AT THE NEXT SCHEDULED VISIT, RECONSENT OBTAINED AT A LATER VISIT; DEVIATION DID NOT RESULT IN AN Protocol DeviationInformed Consent FOLLOW-UP2020-08-28B;mRNA-1273-P201DVmRNA-1273-P201-US208-1099US2081099AICF NOT SIGNED OR INCORRECT ICF SIGNED OR ICF NOT SIGNED AND DATED BY SUBJECT, LAR AND INVESTIGATOR OR SIGNED AFTER COMMENCING STUDY PROCEDURES; RECONSENT NOT COLLECTED FOR NEW ICF; DEVIATION ICH/GCP Deviation ICF Process/Timing FOLLOW-UP2020-08-26B>mRNA-1273-P201DVmRNA-1273-P201-US208-1100US2081100AVISIT COMPLETED OUT OF WINDOW (EXCLUDING DOSING VISITS) Protocol DeviationVisit Scheduling FOLLOW-UP2020-09-10BGmRNA-1273-P201DVmRNA-1273-P201-US208-1103US2081103AVISIT COMPLETED OUT OF WINDOW (EXCLUDING DOSING VISITS) Protocol DeviationVisit Scheduling TREATMENT2020-07-08ApmRNA-1273-P201DVmRNA-1273-P201-US208-1104US2081104ASUBJECT DOES NOT MEET ENTRY CRITERIA (EX#18) (EXCLUSION CRITERIA MET, BUT SUBJECT RANDOMIZED) Protocol DeviationExclusion Criteria SCREENING2020-06-23mRNA-1273-P201DVmRNA-1273-P201-US208-1104US2081104A VISIT COMPLETED OUT OF WINDOW (EXCLUDING DOSING VISITS) Protocol DeviationVisit Scheduling TREATMENT2020-07-08ApmRNA-1273-P201DVmRNA-1273-P201-US208-1108US2081108AICF INCORRRECTLY SIGNED OR DATED BY SUBJECT, LAR AND/OR INVESTIGATOR; ICF RECONSENT NOT COLLECTED AT THE NEXT SCHEDULED VISIT, RECONSENT OBTAINED AT A LATER VISIT; DEVIATION DID NOT RESULT IN AN Protocol DeviationInformed Consent FOLLOW-UP2020-08-28B9mRNA-1273-P201DVmRNA-1273-P201-US208-1108US2081108A SUBJECT DOES NOT MEET ENTRY CRITERIA (EX#18) (EXCLUSION CRITERIA MET, BUT SUBJECT RANDOMIZED) Protocol DeviationExclusion Criteria SCREENING2020-06-23mRNA-1273-P201DVmRNA-1273-P201-US208-1108US2081108A0VISIT COMPLETED OUT OF WINDOW (EXCLUDING DOSING VISITS) Protocol DeviationVisit Scheduling TREATMENT2020-07-09ApmRNA-1273-P201DVmRNA-1273-P201-US208-1110US2081110AICF INCORRRECTLY SIGNED OR DATED BY SUBJECT, LAR AND/OR INVESTIGATOR; ICF RECONSENT NOT COLLECTED AT THE NEXT SCHEDULED VISIT, RECONSENT OBTAINED AT A LATER VISIT; DEVIATION DID NOT RESULT IN AN Protocol DeviationInformed Consent FOLLOW-UP2020-08-28B9mRNA-1273-P201DVmRNA-1273-P201-US208-1112US2081112AICF NOT SIGNED OR INCORRECT ICF SIGNED OR ICF NOT SIGNED AND DATED BY SUBJECT, LAR AND INVESTIGATOR OR SIGNED AFTER COMMENCING STUDY PROCEDURES; RECONSENT NOT COLLECTED FOR NEW ICF; DEVIATION ICH/GCP Deviation ICF Process/Timing TREATMENT2020-08-26B7mRNA-1273-P201DVmRNA-1273-P201-US208-1112US2081112A VISIT COMPLETED OUT OF WINDOW (VISITS WHERE IMMUNOGENECITY SAMPLES ARE COLLECTED) Protocol DeviationVisit Scheduling TREATMENT2020-08-11B(mRNA-1273-P201DVmRNA-1273-P201-US208-1113US2081113AICF INCORRRECTLY SIGNED OR DATED BY SUBJECT, LAR AND/OR INVESTIGATOR; ICF RECONSENT NOT COLLECTED AT THE NEXT SCHEDULED VISIT, RECONSENT OBTAINED AT A LATER VISIT; DEVIATION DID NOT RESULT IN AN Protocol DeviationInformed Consent FOLLOW-UP2020-09-08B?mRNA-1273-P201DVmRNA-1273-P201-US208-1116US2081116APROCEDURE NOT PERFORMED (EXCLUDING IMMUNOGENICITY BLOOD DRAWS AND VACCINATIONS) (NASOPHARYNGEAL SWAB COLLECTIONS AT D1, D29, D57, UNS, MAAE) Protocol DeviationStudy Procedures/Assessments TREATMENT2020-07-07AmRNA-1273-P201DVmRNA-1273-P201-US208-1117US2081117AP10.3 VISIT 4 (VACCINE 2) SHOULD HAVE OCCURRED NO LATER THAN 10AUG2020 Protocol DeviationVisit Scheduling TREATMENT2020-08-11B%mRNA-1273-P201DVmRNA-1273-P201-US208-1118US2081118AICF INCORRRECTLY SIGNED OR DATED BY SUBJECT, LAR AND/OR INVESTIGATOR; ICF RECONSENT NOT COLLECTED AT THE NEXT SCHEDULED VISIT, RECONSENT OBTAINED AT A LATER VISIT; DEVIATION DID NOT RESULT IN AN Protocol DeviationInformed Consent FOLLOW-UP2020-08-28B;mRNA-1273-P201DVmRNA-1273-P201-US208-1119US2081119AP10.3 VISIT 4 (VACCINE 2) SHOULD HAVE OCCURRED NO LATER THAN 10AUG2020 Protocol DeviationVisit Scheduling TREATMENT2020-08-11B%mRNA-1273-P201DVmRNA-1273-P201-US208-1120US2081120AICF NOT SIGNED OR INCORRECT ICF SIGNED OR ICF NOT SIGNED AND DATED BY SUBJECT, LAR AND INVESTIGATOR OR SIGNED AFTER COMMENCING STUDY PROCEDURES; RECONSENT NOT COLLECTED FOR NEW ICF; DEVIATION ICH/GCP Deviation ICF Process/Timing FOLLOW-UP2020-08-26B9mRNA-1273-P201DVmRNA-1273-P201-US208-1121US2081121AICF INCORRRECTLY SIGNED OR DATED BY SUBJECT, LAR AND/OR INVESTIGATOR; ICF RECONSENT NOT COLLECTED AT THE NEXT SCHEDULED VISIT, RECONSENT OBTAINED AT A LATER VISIT; DEVIATION DID NOT RESULT IN AN Protocol DeviationInformed Consent TREATMENT2020-08-24B2mRNA-1273-P201DVmRNA-1273-P201-US208-1123US2081123AICF NOT SIGNED OR INCORRECT ICF SIGNED OR ICF NOT SIGNED AND DATED BY SUBJECT, LAR AND INVESTIGATOR OR SIGNED AFTER COMMENCING STUDY PROCEDURES; RECONSENT NOT COLLECTED FOR NEW ICF; DEVIATION ICH/GCP Deviation ICF Process/Timing FOLLOW-UP2020-08-25B9mRNA-1273-P201DVmRNA-1273-P201-US208-1123US2081123A VISIT COMPLETED OUT OF WINDOW (VISITS WHERE IMMUNOGENECITY SAMPLES ARE COLLECTED) Protocol DeviationVisit Scheduling TREATMENT2020-08-11B+mRNA-1273-P201DVmRNA-1273-P201-US208-1129US2081129AP05: SUBJECT RECEIVED VACCINE IN DIFFERENT ARMS ON DAY 1 AND DAY 29 Protocol DeviationStudy Treatment Admin/DispenseTREATMENT2020-08-30B<mRNA-1273-P201DVmRNA-1273-P201-US208-1129US2081129A VISIT COMPLETED OUT OF WINDOW (EXCLUDING DOSING VISITS) Protocol DeviationVisit Scheduling TREATMENT2020-07-08ApmRNA-1273-P201DVmRNA-1273-P201-US208-1129US2081129A0VISIT COMPLETED OUT OF WINDOW (EXCLUDING DOSING VISITS) Protocol DeviationVisit Scheduling TREATMENT2020-08-24B6