Healthcare Clinical Trial Addendum

HEALTHCARE CLINICAL TRIAL ADDENDUM

Patient Information

Patient Name:    Date of Birth:

Insurance and Billing

Clinical Trial Identification

Study Title:

Protocol Number:    Sponsor:

Principal Investigator:    Site:

Enrollment Date (if enrolled):    Study Phase: Phase I Phase II Phase III

Addendum Purpose and Scope

This Clinical Trial Addendum supplements and modifies the previously executed informed consent for clinical care or research. All terms of the existing consent remain in force except as expressly modified below. By signing this addendum, the patient acknowledges receipt of trial-specific information and consents to the additional procedures and disclosures described herein.

Trial Procedures, Duration and Additional Visits

Risks, Benefits and Alternatives

The patient acknowledges that participation in the trial may involve risks not associated with routine care and that potential benefits specific to the investigational intervention have been explained. The patient retains the right to withdraw from the trial at any time without penalty to their standard medical care.

Costs, Compensation and Injury

Will the patient incur additional costs as a result of trial procedures?    Yes    No

Will the patient receive compensation for participation?    Yes    No

In the event of trial-related injury, medical care will be provided as described in the informed consent and as required by applicable regulations. Information about compensation or treatment for research-related injury has been provided.

Confidentiality, Data Use and Record Release

The patient authorizes release of relevant medical records and trial data to the sponsor, monitor, ethics committee, and regulatory authorities for the purposes of monitoring, audit, and regulatory compliance. Such disclosures may include identifiable health information as necessary. De-identified data may also be used for future research and publication.

I authorize release of my medical information as required for the conduct of this study:    I authorize

HIPAA Authorization for Research Use

By signing this addendum I authorize use and disclosure of my protected health information (PHI) for the purposes of the clinical trial, including collection, analysis, and long-term storage. I understand that my authorization is voluntary and that I may revoke it in writing except to the extent that action has already been taken in reliance on this authorization.

Withdrawal and Questions

Participation in the trial is voluntary. I may withdraw consent for trial procedures at any time without prejudice to my ongoing medical care. Withdrawal procedures and consequences have been explained to me, including how my data collected prior to withdrawal will be handled.

Prior Consent Reference

This addendum references the original informed consent signed on: . Protocol documents and the informed consent form provided earlier continue to govern except as modified herein.

Acknowledgment and Consent

By signing below, I acknowledge that I have read and understand this Clinical Trial Addendum, that my questions have been answered, and that I consent to the additional procedures, uses, and disclosures described above. I understand I may revoke this authorization in writing to the study contact, except to the extent that the study has already acted in reliance on this authorization.

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