Institution-specific · Research institution
Separate authorization for use and disclosure of PHI for research purposes. May be broader than clinical HIPAA authorization.
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Sign at the research site, typically alongside the informed consent form
This authorization is required by HIPAA before your protected health information can be used for research.
Immediate upon signing. Researchers can access your specified health information after authorization is documented.
The research team can access and use your protected health information as described in the authorization. You will receive a copy. You can revoke the authorization at any time in writing, but revocation does not affect information already collected.
Study-specific · Study sponsor / institution
Comprehensive document explaining the clinical trial: purpose, procedures, risks, benefits, alternatives, voluntariness, and right to withdraw. Must be approved by IRB.
Study-specific · Study sponsor
Checklist confirming the participant meets all inclusion criteria and no exclusion criteria for the clinical trial.
FDA Form 3926 · U.S. Food and Drug Administration
Simplified form for requesting compassionate use of investigational drugs for patients with serious or life-threatening conditions and no alternatives. FDA approves over 99% of requests. Requires manufacturer agreement to provide the drug.
FDA Form 1571 · U.S. FDA
Traditional IND application form for expanded access submissions. Form 3926 is the simplified alternative for individual patients.
FDA Form 1572 · U.S. FDA
Statement of investigator qualifications and commitment to conduct the study per FDA regulations. Accompanies IND submissions.
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