/ Human Research Protection Program
Institutional Review Board
Continuing Review Progress Report
If all protocol specific activities, including enrollment, interventions, follow-up, data queries or analysis are complete.
DO NOT COMPLETE THIS FORM.
Please complete the Study Completion Form This can be found at under the IRB forms and templates.
Protocol Specific Information
Principal Investigator: / Date:
Research Coordinator:
Project Title:
IRB#: / Expiration Date: / Return By:
Study Status (check only one)
Enrolling/recruiting subjects (Complete Section A, B, C)
Data/Specimen Bank/Repository or Registry (enrolling/recruiting/or collecting information about
subjects) (Complete Section A,B, C & E)
Closed to enrollment, conducting protocol specific interventions (Complete Section A, B, C )
Closed to enrollment, conducting long term follow up and/or data queries (Complete Section A, B, C)
Study not begun (please explain in Section D)
Data analysis (please explain in Section D)
In research, intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes.Examples of follow-up only: Phone calls, surveys and other methods of gathering research information that does not involve an intervention.
Section A Total Number of Subjects Enrolled at MMC
  1. How many subjects were enrolled since your last progress report?

  1. What is the total number of subjects enrolled in all years?

  1. What was the number of subjects you anticipated recruiting (from your original IRB application or subsequent amendment)?

  1. If you are having difficulty or have been unable to enroll subjects, please explain.

Section B Financial Interest Declaration
  • You must disclose any new financial interests within 30 days of becoming aware of these interests.
  • Any new Key Personnel must disclose financial interests.
  • If you have anything new to disclose please go to the Disclosure Form.
By checking the following box, I attest that I have disclosed all of my financial interests.
Any questions about Potential/Perceived Conflicts of Interest please call Jan Trott 396-8182
Section C New Information
You are required to review and report any new information to the IRB during this review period to determine if the risk to subjects have changed.
  1. Have the inclusion/exclusion criteria changed since your last review?
If yes, please explain: / Yes No
  1. Have any subjects withdrawn from the study since your last review?
If yes, please explain: / Yes No
  1. Have you received any complaints about the research from study subjects or their family?
If yes, please explain: / Yes No
  1. Have there been any unanticipated problems, event reports or study modifications that have NOT been submitted, per IRB policy and sponsor requirements?
If yes, please submit on the proper form (i.e. amendment or new information) / Yes No
  1. In the opinion of the principal investigator, have the risks or potential benefits of this research changed?
If yes, please explain: / Yes No
  1. If this is an industry sponsored study, how many monitoring visits or remote monitoring visits were completed since your last renewal?
/ N/A
  1. If this study is closed to enrollment and you are conducting protocol specific interventions, please define the interventions:
/ N/A
  1. What is the current version of the protocol (if applicable)? Version/Date:

  1. What is the current version of the Investigators Brochure (if applicable)? Version/Date:

Section D Additional Information
Please provide any additional information that you think would be important for the IRB to know when making their decision regarding the continuation of this study.
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Section E Repository Form
Researcher or Company Representative Requesting Data/Tissue / Company or Institution
(i.e. Jackson Lab, MMCRI, Abbott) / Title of Project, if applicable / Samples/date requested / Outcome
(e.g. approved, rejected, pending)

If this project was approved by an IRB outside of the MMC’s IRB, please attach a short summary, Materials Transfer Agreement or Contract Agreement that describes the proposed request and their certification that this will be carried out after appropriate IRB review and/or approval has been granted.

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Return completed form to the Research Compliance Office along with:

1 (one) copy of the current research summary/plan.

Any interim findings, multi-center trial reports or Data Safety Monitoring Board Reports reported since your last review.

If a subject has been enrolled during this review period please include 1 (one) copy of a signed informed consent document (de-identified by blackening out subject’s name/signature).

If the study will continue to enroll/recruit subjects please include 1 (one) copy of the informed consent document (in the form of a word doc). Please include an amendment form if the submitted version has not been approved by the IRB.

If you have any questions regarding completion of this report, please call the Research Compliance Office at 396-8183.

I attest that all new information has been provided to the IRB, including all serious and related adverse events, changes to the research plan and/or consent document and changes in personnel.

Signature of Principal Investigator/Date

Signature of Division Director/Practice Administrator/or Designee / Date

Please submit this form with any supporting documents by emailOffice of Research Compliance at

IRB USE ONLY:
Approved as submitted
IRB Reviewer
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