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Supporting Education and QI in Research (SEQuR)

16. What is the Process for Review and

Execution of a Clinical Disclosure Agreements or a Clinical Study Contract Agreement?

All Confidentiality Disclosure Agreements and Clinical Trial Agreements must be sent to the Office of Sponsored Research for internal administrative review and processing.   The following should be considered:

 

1. The PI or study coordinator should ask the sponsor to send the contract agreement electronically to libbys@mmc.org. Maine Medical Center's standard contract language will be incorporated into the document in redlined form and returned to the sponsor electronically for review.

 

2. Provide the clinical research coordinator's name, telephone number and fax number.

 

3. Provide the name of a contact person at the company with their email address, telephone number and fax number.

 

4. Provide an electronic copy of the objectives section from the protocol to libbys@mmc.org.

 

5. Indicate when the project will be submitted to the IRB.

 

6. Provide a federal express or airborne express form, if provided by the sponsor, to expedite return of the contracts.

 

7. The Agreement/amendment will be reviewed and revisions incorporated by the Office of Sponsored Research and copies will be forwarded to the appropriate Department Chief, AVP/Research, and Financial Services. Financial Services will contact the study coordinator to develop an internal budget.

 

8. Once the contract language has been agreed upon, final agreements will be generated; approvals from internal administrative reviewers will be collected and the internal budget finalized.

 

9. The Research Grant & Contract Specialist will arrange for the contracts to be signed by the AVP/Research; Agreements will be returned to the sponsor and a copy forwarded to the PI/coordinator.

 

10. Upon receipt of the fully executed Agreement by the Office of Sponsored Research, the original will filed and a copy will be forwarded to Financial Services along with a request that a specific purpose account be established for the study; a copy of the Agreement will also be forwarded to the PI along with a cover letter stating that patients can be enrolled in the study (as long as IRB approval has been obtained).

 

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Maine Medical Center Research Institute 81 Research Dr Scarborough, ME 04074 (207)396-8100

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