protocol amendment
Request for changes to approved research (amendment request)
Investigators wishing to make any changes to already approved proposal must apply to the CHS-IRB in writing during the active, approved period of the study. All modifications/changes in a project must be submitted to the IRB and approved before they are initiated, except where necessary to eliminate apparent immediate hazard to the study participant.
Requests for approval must include:
- A cover letter with the project name, number and name of PI and must clearly specify that an amendment is being requested.
- A properly completed protocol amendment submission form, signed by the PI. The amendment/s with detailed justification for the changes should be included in the form.
- For research projects that require changes in documents given to participants or any recruitment materials , a copy of the currently approved and in use document , plus a copy of the new document that reflects the changes due to the amendment (highlight changes) and one clean copy of the new document
- After review by the IRB, and when the amendment is approved, an approval letter will be sent to the investigator. Approval of an amendment does not alter the date of the protocol approval date.
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