Concomitant Documentation and Case Report Forms (CRF/eCRF). Medications Protocol prohibited medications are found in Source Documentation/(e)CRF. If yes, review protocol and eligibility. Study product has been administered per protocol/MOP and documented accordingly. Study Product Note: This includes a review of the documentation Administration supporting correct mixing procedures, labeling, cold Processes and custody chain, licensed personnel, and blinded/unblinded handling and administration. UP, AE, SAE UPs, AEs, and SAEs have been identified, recorded, Identification and and reported properly and within the specified timelines. Reporting The participant has missed one or more study visits. If yes, missed visits are documented according to Missed Visits and protocol and institutional requirements. Follow-up Documentation of attempts to contact the participant is present (i.e., phone call, certified mail, etc.) If missed visits resulted in a protocol deviation, they have been recorded as protocol deviations. All protocol-required lab tests and procedures have Missed Lab been performed. Tests/Procedures If no, missed tests/procedures have been reported as Protocol Deviations. Study Product / If the participant has discontinued study product or Study study visits, all protocol-required steps have been followed. Discontinuation Source Documentation Standards are being Miscellaneous followed.
Concomitant Medications Documentation and Case Report Forms (CRF/eCRF). Protocol prohibited medications are found in Source Documentation/(e)CRF. If yes, review protocol and eligibility. Study Product Administration Processes Study product has been administered per protocol/MOP and documented accordingly. Note: This includes a review of the documentation supporting correct mixing procedures, labeling, cold and custody chain, licensed personnel, and blinded/unblinded handling and administration. UP, AE, SAE Identification and Reporting UPs, AEs, and SAEs have been identified, recorded, and reported properly and within the specified timelines. Missed Visits and Follow-up The participant has missed one or more study visits. If yes, missed visits are documented according to protocol and institutional requirements. Documentation of attempts to contact the participant is present (i.e., phone call, certified mail, etc.) If missed visits resulted in a protocol deviation, they have been recorded as protocol deviations. Missed Lab Tests/Procedures All protocol-required lab tests and procedures have been performed. If no, missed tests/procedures have been reported as Protocol Deviations. Study Product / Study Discontinuation If the participant has discontinued study product or study visits, all protocol-required steps have been followed. Miscellaneous Source Documentation Standards are being followed.
qm-subject-participant-data-review-tool.docx