Tip for Study-specific

You have the RIGHT to take the consent form home and review it before signing — never feel pressured to sign on the spot

Tip for Study-specific

Participation is always VOLUNTARY — you can withdraw at any time without affecting your regular medical care

Tip for Study-specific

Ask questions about risks, benefits, alternatives, costs, and what happens if you are injured during the study

Clinical TrialshardDoctor signature required

Informed Consent Document (ICF)

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.

Form Details

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Filled by: patient
Frequency: one time

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Where to Submit This Form

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The informed consent process must be conducted by a qualified member of the research team.

Filing Deadline

Must be signed before any study procedures can begin. You may take the form home to review before signing.

Required Attachments

📎 The Institutional Review Board (IRB)-approved informed consent document
📎 Any applicable addenda or amendments to the consent
📎 HIPAA research authorization (often combined with the ICF or as a separate document)

Processing Time

Immediate upon signing. Study procedures can begin after the consent is documented.

What Happens Next

You will receive a signed copy of the consent form. The research team will proceed with eligibility screening and study enrollment procedures. Your consent is documented in the study records and your medical chart.

Tips for This Form

✓ You have the RIGHT to take the consent form home and review it before signing — never feel pressured to sign on the spot
✓ Participation is always VOLUNTARY — you can withdraw at any time without affecting your regular medical care
✓ Ask questions about risks, benefits, alternatives, costs, and what happens if you are injured during the study
✓ You may be asked to re-consent if the study protocol is amended or new risks are identified

More Clinical Trials Forms

HIPAA Authorization for Research

Institution-specific · Research institution

Separate authorization for use and disclosure of PHI for research purposes. May be broader than clinical HIPAA authorization.

Eligibility Screening / Inclusion-Exclusion Checklist

Study-specific · Study sponsor

Checklist confirming the participant meets all inclusion criteria and no exclusion criteria for the clinical trial.

Individual Patient Expanded Access IND Application

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.

Investigational New Drug Application (IND)

FDA Form 1571 · U.S. FDA

Traditional IND application form for expanded access submissions. Form 3926 is the simplified alternative for individual patients.

Statement of Investigator

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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Disclaimer: BeneFill™ provides form-filling assistance and informational guidance only. It is not affiliated with, endorsed by, or sponsored by the Study sponsor / institution or any government agency. The information provided is for general informational purposes and does not constitute legal, medical, financial, or tax advice. Always verify form requirements and submission details directly with the issuing agency.