Research Committee

Amendment

Review Criteria / Reviewer Form

SP Code:	Date of Meeting or Expedited Review:

Title:

Principal Investigator:	Date Completed by Reviewer:

Background: Changes to approved and funded research that affect the overall goal, specific aims or objectives of the approved project, that substantively alter the research methodology or its application, or proposes to change principal or co-investigator(s) must receive prior approval. (Other changes may be provided in summary fashion in CRR’s.)

Changes will be processed initially through expedited review - by primary reviewers and/or the Chair. Concerns initially identified may be submitted to the Committee Administrator for anonymous presentation to the investigator to request clarification(s). Investigator response(s) may be processed through expedited review, or reviewers may defer to the full Committee at the next scheduled meeting.

Is the proposed modification understandable and adequately reflected in a revised proposal?

Yes

No

Comments/Suggestions:

Is the proposed modification reasonable and necessary for the successful completion of the project?

Yes

No

Comments/Suggestions:

If the proposed modification is likely to affect the statistical significance or analysis plan, was this section of the proposal revised and has the biostatistician involved signed the form?

Yes

No

Comments/Suggestions:

Are remaining funds adequate to complete the project with the proposed revision or have adequate additional funds been requested?

Yes

No

Comments/Suggestions:

Will the Amendment alter the timeline? (Is an updated timeline provided and appropriate?)

Yes

No

Comments/Suggestions:

6.	General Comments / Recommendations:

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 – Amendment – Review Criteria / Reviewer form	Page 2 of 2

Version Date – December 28, 2015

Baer, Patricia E

2016-07-13

Knecht, Justin E

Marshfield Clinic