Here is the Departmental Scientific Review Checklist, if needed.
SUBMISSION INSTRUCTIONS (what is paper, what is electronic): Click here
Reporting timeframes are working days. Timeframes listed are the maximum.
Urgent information that impacts subject safety must be reported to the HSC within 24 hours.
• Reporting Timeframe: Death, 24 hours; Other, 5 days
Problem Report B - External Adverse Drug Event: This form is for an event at an external (non-KUMC) site that is unexpected and related to study participation.
• Reporting Timeframe: 20 days
Problem Report C - Unanticipated Adverse Device Event: This form is for internal and external events relating to devices that are unexpected and related to study participaton.
• Reporting Timeframe: Internal Death, 24 hours; Internal Other, 5 days; External, 20 days
Problem Report D - Report of Non-Compliance: This form is for reporting deviations/violations of the study protocol.
• Reporting Timeframe: 5 days
Problem Report E - Study-Related Complaint: This form is for reporting subject-related complaints about the study.
• Reporting Timeframe: 5 days
Problem Report F - Monitoring/Audit Report: This form is for reporting monitoring/audit reports that indicate problems that could affect the safety of participants, influence the conduct of the study, or alter the HSC's approval to continue the study.
• Reporting Timeframe: 5 days
Problem Report G - Incarceration of a Study Participant
• Reporting Timeframe: 5 days
Problem Report H - Breach of Confidentiality/Loss of Data
• Reporting Timeframe: 5 days
Problem Report I - Other Problems: This form is for reporting all other problems including, but not limited to, equipment problems, availability of test articles/study materials or other availability of resources.
• Reporting Timeframe: 5 days
Report of New Information: This form is for reporting issues including, but not limited to, DSMB or DMC reports, safety reports, toxicology reports, or other interim findings; summaries of study-wide adverse events; suspension or termination of the study due to risk; publication that indicates an unanticipated change to the risk/benefit ratio of the study; an FDA alert, withdrawal from marketing, or other FDA information impacting the risk/benefit ration of the study.