Human Research Review Committee
(HRRC-IRB)
Supported by the
Human Research Protections Office
| HRRC Home > Forms > Submitting a Continuation, Closure, or Reactivation > Re-Approval/Continuation |
Request for Re-Approval/Continuation
Continuation forms are due NO LATER THAN 30 days prior to expiration of study. Please see our compliance policies for more information.
Items Required for EVERY Continuation
ü Progress/Continuation Report
ü Current protocol (electronic) reflecting amendments and changes previously approved by the HRRC. Protocol Guidelines.
Items Required if applicable to Study
ü Current Consent/Assent form (Word Document; single-spaced; 12 pt font) [For studies with continuing enrollment]
ü Last Signed Consent/Assent form (Used to enroll last subject in this review period - black out participant's name and signature - leave dates legible). Scan into a .pdf for email, or fax 505/272-0803.
ü Last Signed HIPAA form (Used to enroll last subject in this review period - black out participant's name and signature - leave dates legible; Same subject as Consent). Scan into a .pdf for email, or fax 505/272-0803.
ü Any Abstracts or Publications published since the last HRRC review.
ü Multi-Center Trial Reports since last HRRC Review
ü Data Safety Monitoring Board Reports since last HRRC Review
ü Sponsorship Information Form and if applicable $750 Review Fee
ü
Attachment D for studies involving
investigational medical devices
ü Attachment 6 Data and Safety Monitoring Plan
ACCEPTABLE METHODS OF SUBMISSION FOR AMENDMENTS, PROGRESS REPORTS, and REACTIVIATIONS:
When you have the above documents ready to send you have three options to get them to us with a signature.
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Email: Forms and all required documents may be emailed to HRRC@salud.unm.edu from the Principal Investigator's email address, we will consider this a signed document. OR
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Fax: If documents are emailed from an email address other than the PIs, the signature page with the PI signature should be faxed to 505-272-0803 immediately after the email is sent. OR
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Scan: If You have scanning abilities, scan the complete document with the signature into a .pdf and email it to HRRC@salud.unm.edu OR
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Deliver: You may also deliver the signed progress report to the HRRC Office and email the required electronic documents.
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