Institutional Review Board

(734) 712-5470

Request for Revision Form

Use this form to request changes to a currently approved study, including adding new documents, changing sites, DSMB reports, notifying the IRB of a recall, etc. The following documents may be submitted at continuing review; monitor site visit report, sponsor annual report to FDA, etc.

Do not use this formfor: deviations, adding or deleting study team members unless part of other changes, or for a Program Review response.

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Current Research Status

Principal Investigator: IRB study #:

Title of research project: Today's date:

  1. a) Is this study currently open to accrual or collecting data? Yes No

b) Is this a change fromwhatwas last reported to the IRB? Yes No

  1. a) Are there currently any participants at SJMHS or affiliated institutions receiving active study treatment/intervention? Yes No N/A - not an intervention study

b) Is this a change fromwhat was last reported to the IRB? Yes No

Type of Revision

  1. Check all that apply:

Protocol

Consent and/or assent form

Recruitment materials, advertisement, e-mail to recruitment

Participant letters or participant study materials

Survey or data collection tools

DSMB report

Investigator brochure

Add or remove a study site recruiting location

Adding or removing study personnelIN ADDITION TO OTHER CHANGES(otherwise use the

Change in Study Team form)

If adding staff:1) attach CITI training completion record, 2) Significant Financial Conflict of Interest Disclosure form either attached as separate document (one e-mail, 2 documents) or submitted within last 12 months, 3) signature page if adding new PI or Sub-I.

Other:

Describe the Revision(s)

  1. List the revision request and all submitted documents exactly as you would like them to appear in the approval letter.
  1. Summarize all of the changes and/or additions, including everything in the list above. Give enough information for an adequate IRB review.

Impact of Revision(s)

Attach all pertinent documents as described below. Revised protocol, investigator brochure, consents, etc. must be in track-changed format to show changes and/or a summary of changes.

  1. Risk assessment:

The reason for the revisiondoes notadd a new risk or increase risks to participants in the study; must explain why this is true:

The reason for the revisiondoesadd a new risk or increase risks to participants in the study; must explain why this is true:

  1. Explain the changes in the risk/benefit ratio:

No change

  1. Is a consent revision necessary?

Yes No N/A - skip to q. 9

If yes, how will the participants be informed?

Re-consent will be obtained from active participants-include explanation:

Participants will be sent a letter (attach letter for IRB review)-include explanation:

Participants will not be informed-include explanation:

  1. Is a protocol revision necessary?

Yes (attach) No

  1. Are there data collection tools, screening tool, or any other documents that need to be revised as a result of the change that you are requesting?

Yes (attach) No

Principal Investigator SignatureDate

Please return this completed form via e-mail to:

REMARKABLE MEDICINE. REMARKABLE CARE.

4/2017