Study Completion Form - Maine Medical Center Research Institute

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Study Completion Form - Maine Medical Center Research Institute
Human Research Protection Program
Institutional Review Board
Study Completion Form
Protocol Specific Information
Principal Investigator:
IRB#:
Date:
Short Protocol Title:
Total Number of Subjects Enrolled at MMC
Since last report
1.
For all years
Withdrawn or removed from study,
please explain.
Reason for Closure (Check All that Apply)
Research never received funding
Sponsor requested closure
Study complete (all data queries complete)
PI no longer at Maine Medical Center or site approved for the research
Protocol closed due to unanticipated problems, DSMB decision, FDA action, etc.
Please explain or attach any relevant information:
Other unexpected reason for closure
Please explain or attach any relevant information:
2.
Have all of the unanticipated problems or unresolved issues related to safety, complaints, or
confidentiality/privacy been previously reported to the IRB?
Yes
No If no, please explain and/or attach Unanticipated Problem or Event Form.
3.
Do you verify that informed consent was obtained from all subjects and that all signed consent forms
are on file?
4.
If this is a registry, bank or repository, please complete the attached Repository Form.
5.
Other things to consider, if applicable:
 Notifying internal resource providers (example: Lab, Nursing, Pharmacy)
 Thanking your subjects for their participation
 Completing the required steps with clinicaltrials.gov
 If a publication or presentation results from this research, please consider sending us a copy
 The principal investigator is required to maintain study records according to Record
Retention policy.
Please explain or attach any relevant information:
Page 1 of 3
SOP # 407-A
Effective Date
04/25/2013
Supersedes 7/23/2012
As the principal investigator, I verify that the provided information is complete and accurate. I
request that this study be closed.
_______________________________/_________
Principal Investigator/Date
___________________________/___________
Division Director/Date
_____________________________________
Print name
___________________________/___________
Chief (or Practice designee)/Date
Please send completed form to the Research Compliance Office email [email protected]
For questions or assistance please call (207) 396-8240
Page 2 of 3
SOP # 407-A
Effective Date
04/25/2013
Supersedes 7/23/2012
Repository Form
Researcher or
Company
Representative
Requesting Data/Tissue
Company or Institution
Title of Project, if
applicable
Samples/date requested
(i.e. Jackson Lab,
MMCRI, Abbott)
Outcome
(e.g. approved, rejected,
pending)
If this project was not approved by our IRB, please attach a short summary, MTA or Contract Agreement that describes the proposed
request and their certification that this will be carried out after appropriate IRB review and/or approval has been granted.
Page 3 of 3
SOP # 407-A
Effective Date
04/25/2013
Supersedes 7/23/2012

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