Healthcare & Wellness

Clinical Trial Participation Informed Consent

Informed consent for participation in a research clinical trial, covering study purpose, investigational treatment, randomization, risks, benefits, voluntariness, and participant rights under 21 CFR Part 50 and 45 CFR Part 46. Single signer (participant).

📄 1 signer📅 30-day expiry🏷 Healthcare & Wellness🔖 consent, oncology, clinical-trial, research, irb, investigational, single-signer, healthcare

About this template

The Clinical Trial Participation Informed Consent is a ready-to-use healthcare & wellness template you can send for signature in minutes. It is written for 1 signer (participant) and, by default, expires 30 days after it is sent if left unsigned. It covers consent, oncology, clinical trial, research, irb, investigational. Like every Abundera Sign template it is a convenience draft structured for ESIGN Act and UETA compliance, not a substitute for legal advice. Each signed copy is sealed with PAdES-LTA digital signatures, dual RFC 3161 timestamps, and a tamper-evident evidence package in WORM storage.

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# Clinical Trial Participation Informed Consent > **Important — not medical advice.** For use by a licensed provider; tailor to the patient, your protocols, and state law. **Date:** ___________ **Institution / Sponsor Site:** ___________ **Principal Investigator:** ___________ **Study Coordinator:** ___________ **Participant Name:** ___________ **Date of Birth:** ___________ **Medical Record Number:** ___________ --- ## 1. Study Identification **Study title:** ___________ **Protocol number:** ___________ **Sponsor:** ___________ **IND / IDE number (if applicable):** ___________ **Phase of study:** ___________ **IRB/IEC approval number:** ___________ **IRB/IEC approval date:** ___________ --- ## 2. Purpose of the Study

Fields (31)

consent date
date · required
institution name
text · required
principal investigator
text · required
study coordinator
text · required
participant name
text · required
participant dob
date · required
mrn
text · required
study title
text · required
protocol number
text · required
sponsor name
text · required
ind number
text
study phase
select · required
irb number
text · required
irb approval date
date · required
study purpose
textarea · required
investigational treatment
textarea · required
study design
select · required
randomization
select · required
comparator
textarea
participation duration
text · required
known risks
textarea · required
procedure risks
textarea · required
radiation exposure
select · required
alternatives discussed
select · required
treatment costs
select · required
compensation
select · required
injury coverage
textarea · required
pi contact
text · required
irb contact
text · required
outstanding questions
textarea
participant signer name
text · required

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Every signed document gets PAdES-LTA digital signatures, dual RFC 3161 timestamps, and a tamper-evident evidence package sealed in WORM storage.

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