Clinical Research Participant Informed Consent Form
Streamline clinical trial enrollment with a comprehensive informed consent form covering risk disclosure, medical history, and participant eligibility screening.
Clinical Research Study Participant Informed Consent & Risk Disclosure Form
Participant Full Name
· · ·
Date of Birth
· · ·
Email Address
· · ·
Submit
The Clinical Research Study Participant Informed Consent & Risk Disclosure Form is a comprehensive digital form designed for research institutions, clinical trial coordinators, and principal investigators who need to obtain legally compliant informed consent from study participants. It captures personal details, emergency contact information, and a thorough overview of the study's purpose, procedures, risks, and benefits.
This template is ideal for hospitals, universities, pharmaceutical companies, and independent research organizations conducting clinical trials or observational studies. It ensures participants have reviewed and understood all relevant study information, including alternative treatments available and potential side effects, before agreeing to participate—helping your team maintain full ethical and regulatory compliance.
By digitizing the consent process, you eliminate paperwork bottlenecks, securely store sensitive participant data in accordance with data protection regulations, and create a clear audit trail. Use this free template to simplify participant onboarding, reduce administrative burden, and uphold the highest standards of research ethics.
4Pages
28Questions
~9minTo complete
FreeNo credit card needed
Field types
Long Text ×6
Yes / No ×5
singlecheckbox ×4
Date ×2
Phone ×2
Full Name
Email
Address
Dropdown
Short Text
richtext
File Upload
termsandconditions
Signature
Questions in this template
Free template
The exact questions included — customize any of them to fit your needs.
Page 1Participant Personal Information8 questions
Participant Personal Information
Please provide your personal details below. All information collected will be kept strictly confidential in accordance with applicable data protection regulations and the study protocol.
1
Participant Full Name
*Full Name
2
Date of Birth
*Date
3
Email Address
*Email
4
Phone Number
*Phone
5
Home Address
*Address
6
Gender
*Dropdown
7
Emergency Contact Name
*Short Text
8
Emergency Contact Phone Number
*Phone
Page 2Study Details & Risk Disclosure7 questions
Study Information & Risk Disclosure
Please carefully review the following details about the research study, including its purpose, procedures, and associated risks. It is important that you fully understand this information before providing your consent.
1
Study Title and Principal Investigator
*richtext
2
Brief Description of the Study Purpose and Procedures
*Long Text
3
Potential Risks and Side Effects Associated with Participation
*Long Text
4
Potential Benefits of Participation
*Long Text
5
Alternative Treatments or Procedures Available
Long Text
6
Have you read and understood the study information sheet provided to you?
*Yes / No
7
Have you had the opportunity to ask questions about the study and received satisfactory answers?
*Yes / No
Page 3Medical History & Eligibility6 questions
Medical History & Eligibility Screening
Please answer the following questions honestly to help the research team determine your eligibility for this study.
1
Do you have any pre-existing medical conditions?
*Yes / No
2
If yes, please list all current medical conditions and medications
Long Text
3
Have you participated in any other clinical research study in the past 12 months?
*Yes / No
4
If yes, please provide details of the previous study
Long Text
5
Are you currently pregnant or planning to become pregnant?
*Yes / No
6
Upload any relevant medical records or documents
File Upload
Page 4Consent & Authorization7 questions
Informed Consent Declaration
By completing this section, you acknowledge that you have been fully informed about the nature, purpose, duration, risks, and benefits of this clinical research study. You confirm that your participation is entirely voluntary and that you may withdraw at any time without penalty or loss of benefits.
1
I confirm that I have read and understood the study information provided and have had all my questions answered to my satisfaction.
*singlecheckbox
2
I understand the potential risks and benefits associated with my participation in this study.
*singlecheckbox
3
I understand that my participation is voluntary and that I am free to withdraw at any time without giving a reason and without my medical care or legal rights being affected.
*singlecheckbox
4
I consent to the collection, processing, and storage of my personal and medical data for the purposes of this research study in compliance with all applicable privacy laws.
*singlecheckbox
5
I have read and agree to the full Informed Consent Document, Study Protocol, and Privacy Notice associated with this clinical research study.
*termsandconditions
6
Date of Consent
*Date
7
Participant Signature
*Signature
How to use this template
Click "Use This Template Free" to open it in the FormBuilder editor. From there you can add, remove, or reorder fields with drag-and-drop, switch themes for instant restyling, add your logo, configure email notifications, and set your success message. When ready, publish with a unique link and start collecting responses immediately.
Ready-to-use structure — pre-configured fields out of the box
Applied "Frost" theme — fonts, colors, and layout already set
Mobile-responsive — works on every device without extra configuration
Fully editable with drag-and-drop — change anything in seconds
Free to use on any plan, no credit card required
Use this template
Free to use. Open in the editor, customize, and publish in minutes.
English
Español
Português
Русский
العربية
