Guidelines for Submitting Continuing Progress Reports
In accordance with FDA regulations 45 CFR 46.109(e), 21.CFR 56.109(f), and institutional policy for the Medical College of Wisconsin and Froedtert Hospital, a continuing progress report must be submitted for review and approval minimally on an annual basis. Factors for making the decision about the frequency of review include the level of risk, location of the study, and any other factors that might affect the welfare of the subjects. Frequency of review is determined by the IRB upon initial review.
It is the Principal Investigator's responsibility to ensure that the Continuing Progress Report (CPR) is complete and returned by the due date to allow the IRB adequate time to conduct continuing review of the study before the expiration date. The deadline for continuing review submissions to the IRB is 60 days prior to the study expiration date. Click for committee deadlines and meeting dates.
CPRs must be submitted in eBridge using the form provided. Exceptions are studies that remain in paper with IRB permission, CIRB protocols, and HUDs. The CPR template for paper submissions can be found on the IRB web site.
Federal regulations require that continuing review of research be substantive and meaningful. During the continuing review, the IRB will determine if the research study continues to meet all criteria set forth by federal regulations in order for the IRB to approve research.
In order for the IRB to comply with these regulations, the Principal Investigator must provide complete information in the Continuing Progress Report submission, including:
- the number of subjects accrued
- a summary of any unanticipated problems and available information regarding adverse events (in many cases, such a summary could be a simple brief statement that there have been no unanticipated problems and that adverse events have occurred at the expected frequency and level of severity as documented in the research protocol, the informed consent document, and any investigator brochure)
- a summary of any withdrawal of subjects from the research since the last IRB review
- a summary of any complaints about the research since the last IRB review
- a summary of any recent literature that may be relevant to the research and any amendments or modifications to the research since the last IRB review
- any relevant multi-center trial reports
- any other relevant information, especially information about risks associated with the research
- a copy of the current informed consent document
Any changes in the consent form must be submitted using an amendment
If continuing review and approval from the IRB does not occur by the continuing review date set by the IRB, all research activities must stop, including:
- enrollment of new participants
- screening and recruiting new participants
- collection of data
- submitting amendments for this study
- submitting continuing progress reports
Any further activity on this study would constitute unapproved human research, and, as such, may be reportable to the Medical College of Wisconsin Institutional Official, FDA, and the OHRP. Research data collected after IRB approval lapsed cannot be used for research purposes.
The HRPP Office should be contacted immediately if it is in the best interest of currently enrolled subjects to continue follow-up or continuation of study treatment so they can safely exit the study.
If the Principal Investigator wishes to reactivate the protocol, contact the IRB Coordinator II responsible for the Committee providing oversight for the protocol.