Healthcare Study Plan Amendment

HEALTHCARE STUDY PLAN AMENDMENT

Study Title:

Protocol Number:     Amendment Number:

Sponsor:     Institution:

Principal Investigator:     Original Approval Date:

AMENDMENT IDENTIFICATION

Effective Date of Amendment:

SPECIFIC CHANGES

REGULATORY REVIEW

IRB / REB Name:

IRB Approval Required: Yes No     IRB Reference Number:

IRB Decision Date:

PARTICIPANT IMPACT

Does the amendment increase participant risk or change key protocol procedures? Yes No

Re-consent of participants required? Yes No

IMPLEMENTATION & TRAINING

Will staff training be required to implement this amendment? Yes No

DATA, RECORDS & RETENTION

Does the amendment change data retention or access to protected health information? Yes No

RISK/BENEFIT ASSESSMENT & CERTIFICATION

The Sponsor and Principal Investigator certify that, to the best of their knowledge, the changes described in this amendment have been assessed for safety and ethical impact and will be implemented only after required approvals are obtained. All study activities will continue to comply with applicable regulations, institutional policy, and the decisions of the IRB/REB.

Authorization Expiration Date (if applicable):

By signing below, the undersigned represent and warrant that they are authorized to execute this amendment on behalf of their respective organizations and that implementation of this amendment will not commence until all required institutional and regulatory approvals are in place.

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