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Study-specific · Study sponsor
Checklist confirming the participant meets all inclusion criteria and no exclusion criteria for the clinical trial.
Institution-specific · Research institution
Separate authorization for use and disclosure of PHI for research purposes. May be broader than clinical HIPAA authorization.
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.
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.
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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