Healthcare Clinical Trial Services Form

Healthcare Clinical Trial Services Form

Purpose: This form documents participant identification, authorization, medical history, insurance billing instructions, and informed consent for participation in the clinical trial services described below. Completion of this form authorizes release of medical records necessary for study conduct, documents acceptance of financial responsibilities as indicated, and records the participant's informed consent to trial-related services. Participation is voluntary and may be discontinued by the participant at any time without penalty.

Participant Information

Date of Birth:    Gender:    Medical Record #:

Phone:    Email:

Relationship:    Phone:

Insurance & Billing Information

Policy/ID Number:    Group Number:

Relationship to Subscriber:

Study / Trial Details

Protocol ID:    Sponsor / CRO:

Principal Investigator:    Site Location:

Screening and eligibility assessment
Investigational product administration
Laboratory testing and specimen collection
Radiology / imaging procedures
Follow-up visits and monitoring
Biospecimen storage for future research

Medical History & Current Health

Pregnancy status (if applicable):

Risks, Benefits, and Participant Rights

I acknowledge that I have received an explanation of the purpose of the study, the procedures to be performed, foreseeable risks and discomforts, potential benefits, and available alternative treatments. I understand that there may be no direct medical benefit to me and that unforeseen risks may occur. I understand my right to ask questions and to withdraw from the trial at any time without jeopardizing my routine medical care.

I understand that the study team will document adverse events and that I should report any new symptoms promptly. In the event of an emergency related to trial participation, I authorize emergency medical treatment as necessary.

Acknowledgment of Risks and Rights: I acknowledge that I have received information about risks and participant rights.

Authorization for Release and Use of Medical Information

I authorize my healthcare providers and facilities to disclose my protected health information, including medical records, laboratory results, imaging, and pathology reports, to the study sponsor, sponsor representatives, contract research organizations, and regulatory bodies for the purpose of study conduct, monitoring, and regulatory compliance. De-identified data may be used for future research as permitted by law.

Authorization Expiration Date:

Authorization to Release Records: I authorize release of my medical information as described above.

HIPAA Privacy & Confidentiality

I acknowledge receipt of the study privacy notice describing how my protected health information may be used and disclosed for research purposes. I understand the measures that will be taken to protect my confidentiality and that absolute confidentiality cannot be guaranteed due to required reporting and regulatory oversight.

HIPAA Authorization: I authorize use and disclosure of my protected health information for the purposes of this research study under the terms stated above.

Costs, Compensation & Injury

I understand which procedures are research-related and which are considered standard medical care. I have been informed which costs, if any, will be billed to my insurance and which will be covered by the sponsor or study funds. I have been informed about available medical treatment and compensation in the event of study-related injury, if applicable, and understand the procedure for reporting and obtaining care.

Billing Authorization: I authorize billing of my insurance for covered clinical services not paid by the sponsor.

Additional Consents

Future contact for long-term follow-up: I agree to be contacted for follow-up related to this study.

Use of de-identified specimens for future research: I consent to storage and future use of de-identified biospecimens.

Acknowledgment and Certification

By signing below I certify that the information I have provided is true and accurate to the best of my knowledge. I further certify that I have had an opportunity to discuss the study, to have my questions answered, and that I freely consent to the services and authorizations indicated on this form. I understand that I may revoke authorizations in writing, except to the extent that action has already been taken based on this authorization.

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