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Research Coordinator

Clinical Research Coordinator Resources

 

News and Information

HRPP eNews    (click here to view in pdf)

Revised Policies

1.      New Information Reporting Form to be used for reporting any unanticipated events that occur after the IRB approves your project.

2.      Initial Notice to IRB:  Report within 48 hours any deaths or serious adverse events that occur at MMC.

3.      Revised IRB Fee Policy Effective 08/01/2013, the IRB processing fees will increase. 

New News    

4.      Results of recent file reviews noted that there is a lack of clarity in patient informed consents regarding expense reimbursement and study stipends.  Expenses should be noted separately as they are not taxable.

5.      Results of recent reviews demonstrate the need to be aware:  If a sponsor representative is required to be present during the treatment of a study subject in any specific treatment area (i.e., operating room or cath lab) for the research project, the informed consent must include this information.

6.      21 CFR Part 11 - Electronic Records; Electronic Signatures

See information regarding MMC's compliance requirement with 21 CFR Part 11,             (electronic records and electronic signature).

 

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

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