Healthcare Protocol Application

HEALTHCARE PROTOCOL APPLICATION

Facility Name:

PATIENT INFORMATION

Date of Birth:    Gender:

Primary Phone:    Email:

EMERGENCY CONTACT

Relationship:    Phone:

INSURANCE INFORMATION

Policy Number:    Group Number:

MEDICAL HISTORY

PROTOCOL DETAILS

Protocol Identifier/Number:    Principal Investigator/Physician:

Proposed Start Date:    Estimated End Date:

Anticipated Interventions (check all that apply):

Medication administration
Blood draws / phlebotomy
Imaging (MRI/CT/X-ray)
Sedation / anesthesia
Device implantation or use
Physical therapy / functional testing
Other (describe below)

Will specimens or data be stored for future use?    Yes    No

LEGAL CONSENT AND CERTIFICATIONS

By signing below I certify that I have read and understand the protocol description provided above. I understand that participation is voluntary, that refusal to participate or withdrawal from the protocol at any time will not result in loss of benefits to which I am otherwise entitled, and that I may withdraw consent without penalty. I acknowledge that the principal investigator or treating physician has explained the purpose, procedures, foreseeable risks, potential benefits, and reasonable alternatives to participation.

I authorize the clinical team and designated study personnel to perform the procedures described in this application and to collect necessary medical information, specimens, and test results for the purposes of the protocol. I understand that any treatment or procedure performed as part of this protocol may involve risks beyond standard care and that those risks have been explained to me.

I understand my financial responsibility: procedures billed as standard clinical care will be submitted to my insurer; protocol-specific costs not covered by insurance will be the responsibility of the sponsor or as otherwise disclosed. I have been informed of who is responsible for costs associated with the protocol and given an opportunity to ask questions.

PRIVACY AND HIPAA AUTHORIZATION

I authorize the use and disclosure of my protected health information (PHI) as necessary for treatment, payment, and healthcare operations related to the protocol and as required for reporting adverse events. I understand that information collected for the protocol may be de-identified for future research. I acknowledge receipt of the facility's privacy practices and understand how my information will be used and protected.

I acknowledge that I may revoke this authorization at any time in writing, except to the extent that action has already been taken in reliance on this authorization. If I revoke this authorization, I understand that it will not affect actions taken prior to the revocation.

Patient acknowledges privacy notice and authorizes use of PHI for purposes of the protocol: Acknowledged

ADDITIONAL ADMINISTRATIVE INFORMATION

Study Coordinator / Contact Phone:    Study Coordinator Email:

PATIENT CONSENT AND SIGNATURE

By signing below I affirm that I am the patient or legally authorized representative and that I have read, understand, and agree to the terms and statements contained in this Healthcare Protocol Application. I certify that the information I have provided is true and complete to the best of my knowledge.

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