Healthcare CRA Form

Healthcare CRA Form

This Clinical Research Authorization (CRA) documents voluntary authorization to collect and use protected health information and related specimens for the research study identified below. By signing this form the patient authorizes the use and disclosure of the patient’s health information as specified and acknowledges the rights and disclosures described herein.

Study Identification

Patient Information

Date of Birth:    Gender: Male   Female   Other / Prefer to describe:

Emergency Contact

Insurance Information

Medical History

Details of Research Procedures

Authorization and Consent

I authorize the research team to obtain, use, and disclose my protected health information (PHI) for purposes of this study as described below. I understand that my participation is voluntary and that I may withdraw this authorization at any time by providing written notice as described in this form. Withdrawal will not affect any actions already taken based on this authorization.

I authorize collection of the following study materials and records (check all that apply):
Medical records (clinic notes, hospital records, discharge summaries)
Laboratory results and pathology reports
Radiology images and reports (x-ray, CT, MRI)
Biological specimens (blood, tissue) for testing and storage
Billing and insurance information related to study procedures

I understand that my participation will not necessarily result in direct medical benefit to me. The research team has explained the risks, potential benefits, and available alternatives. I understand that routine clinical care outside this study remains available to me whether or not I participate.

HIPAA Authorization for Use and Disclosure of PHI

By signing below, I specifically authorize the disclosure of my PHI as described in this authorization to the following recipients for research-related purposes: research staff at the study site, the study sponsor, contract research organizations, laboratories performing testing, and authorized regulatory agencies. I understand that the information disclosed may include sensitive information such as substance use, mental health, genetic testing results, and infectious disease status where relevant to the study.

I acknowledge that once my PHI is disclosed to entities outside the study site, it may be subject to re-disclosure and may no longer be protected by privacy laws; however, the study team will make reasonable efforts to require recipients to protect my information and to limit redisclosure.

No expiration; authorization remains in effect unless revoked in writing.

Optional Consents (initial or check to agree)

I agree to be contacted in the future about other research studies for which I may be eligible.
I consent to genetic testing of collected specimens for the purposes described in the study protocol.
I consent to audio and/or video recording of study visits if applicable.

Revocation of Authorization

I understand I may revoke this authorization at any time by delivering a written revocation to the study contact listed above. Revocation will be effective upon receipt, but will not affect disclosures or actions taken prior to receipt of revocation that were made in reliance on this authorization.

Certification

By signing below I certify that I have read (or had read to me) the information on this form, that the research study, procedures, risks, benefits, and alternatives have been explained to my satisfaction, and that I have had the opportunity to ask questions which were answered. I understand that I will receive a copy of this signed authorization.

I acknowledge that I understand the contents of this authorization.

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