Research Committee

Continuing Review

Review Criteria / Reviewer Form

SP Code:	Meeting Date:

Title:

Principal Investigator:	Date Completed by Reviewer:

Background: Projects receiving internal funds are typically reviewed at the following frequency when the study progresses on track: 4 months after funding, 12 months after funding, 1 year from the previous review, and 1 month after projected completion date. Other frequencies are appropriate when it appears important to oversee progress more closely. A study is considered complete when an abstract, manuscript, final project summary, or an explanation of why a project cannot be completed is provided for the committee’s approval.

What is the current study status?

Initial Progress (1st review after funding):

N/A (skip to Section 3)

Does the initial progress appear adequate (e.g., enrollment, data collection, staffing, budget, etc.)?

Yes

No

Comments/Suggestions:

Overall Study Progress (CRR Section 3):

Does the current timeline adequately show study progress?

Yes

No

Comments/Suggestions:

What is the estimated completion date of the project?

Is a timeline extension requested in this CRR?

Yes

No

If “Yes,” is appropriate rationale provided?

Yes

No

Comments/Suggestions:

Does the CRR provide an adequate summary of study progress since the last report (e.g., enrollment, sample/data collection, specific aim activity, etc.)?

Yes

No

Comments/Suggestions:

Is the progress reasonable?

Yes

No

Comments/Suggestions:

If delays have occurred, are they adequately described and addressed?

Yes

No

Comments/Suggestions:

Results (CRR Section 4): ( Important if this is a termination report.

Does the CRR contain a brief summary of results obtained to date?

Yes

No

Comments/Suggestions:

Are any manuscripts, abstracts, or presentations included in the report or described in plans?

Yes

No

Comments/Suggestions:

Budget (CRR Section 5):

Are there any significant changes to the budget?

Yes

No

If “Yes,” is an explanation provided?

Yes

No

Comments/Suggestions:

Are remaining funds sufficient to complete the project? (If not, how will the study be completed?)

Yes

No

Comments/Suggestions:

6.	Guidance and Recommendations:

Reviewer Guidance: Please give careful consideration to Committee actions on CRR’s. Ideally, we strive to be consistent with decisions and ensure requests are reasonable without placing undue burden on the investigator.

Recommendation to Investigator: (often changes through Committee discussion)

Project should be approved to continue.

The next CRR should be requested in months.

If there are expectations for inclusion in the next report, please list:

…OR…

Project should be terminated.

…OR…

Review should be tabled to obtain the following information:

…OR…

Approve CRR contingent based on obtaining the following information:

…OR…

Last resort of suspension or termination needed. Explanation:

Comments/Suggestions:

If the report is not clear or if questions are not adequately answered, please contact the Committee Administrator, Patti Baer (baer.patricia@mcrf.mfldclin.edu or phone #1-8840), to anonymously request additional information or clarification from the investigator.

Research Committee – Continuing Review – Review Criteria / Reviewer form	Page 2 of 3

Version Date – December 28, 2015

Baer, Patricia E

2016-07-13

Knecht, Justin E

Marshfield Clinic