SUPPLEMENT: Progress Report

for 7 Year de novo IRB Protocol Applications

A. Protocol Information

Title of Protocol
Protocol #
Principal Investigator

B. Progress report - since the last IRB approval

Briefly summarize the progress of the study since the last IRB approval

C. Research activities - since the last IRB approval

Indicate all types of research activities that were conducted on this protocol since the last IRB approval date.

Active collection of data from subjects (not biological materials or physiological data)
Active collection and use of biological materials or physiological data from subjects
Use of physiological or biomedical devices, drugs, biologics, or chemicals with subjects
Use of existing data (not human biological materials)
Use of existing human biological materials
Other (briefly describe):

D. Participants

1. Number of Participants

Total number approved for enrollment:
Number currently enrolled:
Desired but not yet enrolled:

2. During the next year do you plan to recruit new participants?

Yes / No

If yes, please explain:

3. Do you plan to collect additional data from currently enrolled research participants?

Yes / No

If Yes, please describe the types of information and study procedures that you plan to conduct during the coming year (or approval period if less than a year).

If No, indicate if you are moving into a data analysis/manuscript phase only for the coming year (or provide other explanation).

4. Since the last IRB approval has there been any of the following:

Yes* / No
a) Serious adverse event that was not already reported?
b) Unexpected problems involving risk to human participants or others that was not already reported?
c) Subject withdrawals from the study or complaints about the research activities?
d) Discovery of any literature relevant to this research?
e) Interim Findings of relevance to continuing aspects of study?
f) Changes/modifications to your study (including study location/performance sites, recruitment, informed consent, study design and/or research procedures, research personnel, etc.) not previously disclosed or approved by the IRB?
g) Noncompliance with research policies or IRB requirements that was not already reported?
h) Report about activities within a multi-site trial (from the sponsor, another IRB, another PI, or other source) that might affect the rights or welfare of human participants and that was not already reported?
i) Other issues not covered above?

*For any “yes” response, please list category and describe fully here (attach materials as needed to this application at submission):


Form Version: 11/15/17