Investigators must promptly report the following events and information to the HSC:
| Event/Information |
Form |
Reporting Timeframe * |
Internal adverse drug event that is unexpected and related to study participation (Internal events are those occurring to a subjects at any site under the responsibility of the KUMC principal investigator) |
Problem Report Form A |
Death: 24 hrs
Other: 5 days
|
External adverse drug event that is unexpected and related to study participation
|
Problem Report Form B |
20 days |
| Unanticipated adverse device event |
Problem Report Form C |
Internal Death: 24 hrs Internal other: 5 days
External: 20 days
|
Report of Non-compliance (deviations/violations) |
Problem Report Form D |
5 days |
Complaint from a subject related to the study |
Problem Report Form E |
5 days |
Monitoring/audit report indicating a problem that could affect safety of participants, influence the conduct of the study or alter the HSC’s approval to continue the study |
Problem Report Form F |
5 days |
Incarceration of a study subject |
Problem Report Form G |
5 days |
Breach of confidentiality or loss of data
|
Problem Report Form H |
5 days |
Other problems, such as equipment problems, availability of test articles/study materials or availability of resources |
Problem Report Form I |
5 days |
DSMB or DMC reports, safety reports, toxicology reports or other interim findings |
Report of New Information |
20 days |
Summary of study-wide adverse events |
Report of New Information |
|
Suspension or termination of the study due to risk |
Report of New Information |
20 days |
Publication that indicates an unanticipated change to risk/benefit ratio of the study |
Report of New Information |
20 days |
FDA alert, withdrawal from marketing, or other FDA information impacting the risk/benefit ratio of the study |
Report of New Information |
20 days |
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