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Forms

Initial Submission Forms

Here is the Departmental Scientific Review Checklist, if needed.

SUBMISSION INSTRUCTIONS (what is paper, what is electronic):  Click here

Amendments/Changes to Previously Approved Studies

Continuing Review and Closing Studies

  • Continuing Review Form 
    (This form is used for required recertification — annual or six-month — of non-exempt research)
  • Closure Request
    (This form is used when a research study is completed or no longer pursued at KUMC)

Problem Reports

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.

Problem Report A - Internal Adverse Drug Event: This form is for an event that is unexpected and related to study participation (Internal events are those occurring to a subject at any site under the responsibility of the KUMC principal investigator).

• 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.

Supplemental Initial Submission Forms

     Last modified: Jan 28, 2013