Healthcare Trial Form

HEALTHCARE TRIAL FORM

Study Information

Study Title Protocol Number Principal Investigator / Study Physician Study Site / Location Sponsor Study Contact Phone / Pager

Patient Information

Patient Name:

Date of Birth:    Gender (check one): Male Female Other

Relationship:    Phone:

Insurance Information

Policy / ID Number:    Group Number:

Medical History

Pregnant or breastfeeding? Yes No

Implanted medical device (pacemaker, neurostimulator, etc.)? Yes No

Trial Participation Consent and Authorizations

Description of Procedure / Intervention: I acknowledge that the study team has provided a written and verbal description of the study purpose, procedures, expected duration, visits, sample collections, and any study-related devices or medications. I understand that participation involves procedures as described above and that additional procedures may be required by the protocol.

Risks and Benefits: The investigator has explained the foreseeable risks, discomforts, and potential benefits, including that some risks may be unknown. I have had the opportunity to ask questions about potential short-term and long-term effects, and about alternative treatments or procedures.

Voluntary Participation and Withdrawal: I understand that participation is voluntary. I may withdraw from the study at any time without penalty or loss of benefits to which I am otherwise entitled. I understand the process for withdrawal and how to contact the study team.

I consent to participate in the study and to follow study procedures.

I consent to blood draws and biological specimen collection as described in the protocol.

I consent to storage of my biological samples for future research in de-identified form.

I consent to genetic testing of samples when applicable and understand potential implications.

I consent to audio and/or video recording during study procedures as indicated.

Privacy, Data Use, and HIPAA Authorization

Authorization to Use and Disclose Protected Health Information (PHI): By signing below, I authorize the study investigators and authorized study staff to use and disclose my PHI that is necessary for the conduct of the study, including medical records, laboratory results, and other study-related information. This information may be shared with study sponsors, ethics committees, and regulatory authorities as required for oversight and safety monitoring. Identifiable information will be handled in accordance with applicable privacy safeguards and only disclosed as necessary for study purposes.

Re-disclosure: I understand that once PHI is disclosed to certain external parties, federal or state privacy protections may not apply and the information could be subject to re-disclosure. The study team will seek to limit use and disclosure to the minimum necessary for study conduct and compliance.

Authorization Expiration: This authorization will expire on: . If no date is provided, this authorization will remain in effect for the duration of study participation and any follow-up as required by the protocol.

Compensation, Costs, and Emergency Care

I understand whether I will receive payment, reimbursement, or compensation for participation, and any costs that I may be responsible for related to study procedures. I understand the procedures for reporting adverse events and accessing medical care in the event of injury related to the study.

Questions or Concerns: I have had the opportunity to ask questions and have received answers satisfactory to me. I understand I may contact the study contact listed above for study-related questions or for reporting an adverse event.

Acknowledgment and Certification

By signing below I acknowledge that I have read and understand the information contained in this form, that relevant risks and benefits have been explained to me, and that I freely consent to participate. My signature confirms that I have received a copy of this signed form if requested and that all of my questions have been answered to my satisfaction.

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