Institutional Review Board
Continuing Review Progress Report
Protocol Specific Information
Principal Investigator: / Date:
Project Title:
IRB#: / Expiration Date: / Return By:
Study Status (check only one)
Active (still enrolling/recruiting subjects) (Complete Section A)
Closed to enrollment, conducting protocol specific interventions (Complete Section A)
Closed to enrollment, conducting long term follow up and/or data queries (Complete Section A)
Study not begun (please explain in Section B)
Data analysis (please explain in Section B)
None of the above. All protocol specific activities, including enrollment, interventions, follow-up, data queries or analysis are complete. STOP-DO NOT COMPLETE THIS FORM. Please complete the Study Completion Form.
Total Number of Subjects Enrolled at MMC
1. How many subjects were enrolled since your last progress report?
2. What is the total number of subjects enrolled in all years?
3. What was the number of subjects you anticipated recruiting (from your original IRB application or subsequent amendment)?
If you are having difficulty or have been unable to enroll subjects, please explain.
Financial Interest Declaration
· “Immediate Family” means spouse, domestic partner, children, and dependents.
· “Financial Interest Related to the Research” means any of the following interests in the sponsor, product or service being tested, or competitor of the sponsor held by the individual or the individual’s immediate family. Answer the following questions in regards to the PI and CO or Sub-PI
1. Is there ownership interest of any value including, but not limited to stocks and options exclusive of interests in publicly-traded, diversified mutual funds? / Yes No
2. Is there compensation of any amount including, but not limited to honoraria, consultant fees, royalties, or other income? / Yes No
3. Is there proprietary interest of any value including, but not limited to, patents, trademarks, copyrights, and licensing agreements? / Yes No
4. Is there a board or executive relationship with the sponsor, regardless of compensation? / Yes No
If the answer is yes to any of the above, please submit a completed COI Disclosure Form for each investigator with a conflict.
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 AYou 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
2. Have there been any serious and related unanticipated problems or events at this site or other sites (for muti-center sites) over the past year that you feel have increased harm or could have increased harm to study subjects?
If yes, please explain: / Yes No
3. Have any subjects withdrawn from the study since your last review?
If yes, please explain: / Yes No
4. Have you received any complaints about the research from study subjects or their family?
If yes, please explain:
/ Yes No
5. Have there been any 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, SAE, protocol deviation) / Yes No
6. In the opinion of the principal investigator, have the risks or potential benefits of this research changed?
If yes, please explain: / Yes No
7. If this is an industry sponsored study, how many monitoring visits or remote monitoring visits were completed since your last renewal? / N/A
8. If this study is closed to enrollment and you are conducting protocol specific interventions, please define the interventions:
9. What is the current version of the protocol?
Does the IRB have the current version of the protocol on file?
If no, please submit a current version with an amendment request form. / Yes No
Section B
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.
Return completed form to the IRB Office along with:
· 1 (one) copy of the research summary, from the original IRB application, updated if appropriate.
· Attach 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) unstamped copy of the informed consent document. 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 396-8240.
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/DateSignature of Division Director/Practice Administrator/or Designee / Date
Page 3 of 3 / SOP # RR 405-A Effective Date: 10/01/2010 Supersede: 7/28/2004