Start from the sections a clinical research consent form usually contains, adapt each one to your protocol, and move the finished text into an eConsent flow with verified participant and investigator signatures.
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Why you are being asked to take part
What the study involves and how long it lasts
Possible risks and discomforts
Possible benefits and alternatives
Your data and samples
Voluntary participation and withdrawal
Contacts and signatures
Key points
How it works
Search for an "informed consent form generator" and you will find two kinds of tool: a questionnaire that fills in a fixed document, and a text editor with prefilled headings. Both are useful for the same reason. Most of a consent form is structure that repeats from study to study, and the hard part is the study-specific content: what happens at each visit, what the real risks are, what happens to samples and data.
The approach on this page is the second kind, made practical. Work through the section table below, replace the bracketed prompts with your protocol's facts, and keep a short note of which protocol section each statement came from. When a reviewer asks where a sentence came from, you can point to the protocol rather than to memory. The how to write an eConsent form guide covers the writing side in more depth, and the basic clinical trial consent template gives complete starter text.
What a generator cannot do is certify the result. Whether a form meets the requirements of a particular regulator, ethics committee or country is a decision for those bodies and for your sponsor's regulatory team. Nothing here should be read as a statement that a form built from it is legally sufficient. Treat the output as a draft that goes to review.
Template sections
Adapt every row to your protocol. The prompts are questions to answer in plain language, not finished wording.
| Section | What to write | Prompt to answer |
|---|---|---|
| Purpose | Why the study is being done and why this person is asked | What is being tested, in one or two plain sentences? Why is this person eligible? |
| Procedures | What happens, in order, and how long it takes | Which visits, tests, samples and questionnaires, and how many hours or days in total? |
| Risks and discomforts | Known and possible risks, including unknown ones | What are the real risks of the intervention and of each procedure? |
| Benefits | Possible direct benefit, and benefit to others | Is there any expected direct benefit? Say so honestly if not. |
| Alternatives | Other options outside the study | What can the person do instead, including not taking part? |
| Confidentiality and data | Who sees data, where it is stored, for how long | Who has access? Are samples or data shared or reused later? |
| Voluntary participation | No penalty for declining or withdrawing | What happens to data and samples if the person withdraws? |
| Costs and compensation | What the participant pays or receives | Travel, time, injury care and reimbursement. |
| Contacts | Who to call with questions or concerns | Study team, independent contact and emergency instructions. |
| Signatures | Participant, person obtaining consent, and where required witness or representative | Who must sign, and in what order? |
This is a drafting aid. Have the final text reviewed by your ethics committee or IRB and your sponsor.
Modules
A good generator workflow separates the core sections from optional modules, so the base form stays short and each extra topic is added only when it applies. Typical modules are optional biobanking or future-use consent, genetic testing, wearable and sensor data, remote or home visits, pregnancy and contraception, and photographs or recordings. Keeping modules separate also makes it easier to offer them as separate choices, so a participant can agree to the study but decline an optional sample.
Capture's starter library already splits several of these into their own templates: biobank and repository, genomic research, pediatric assent and international multi-site. For device data, see the wearable data sharing consent template, and for remote studies the decentralized trial consent template.
Short sentences, plain words and clear headings do more for understanding than any amount of legal precision. Put the key information a person needs to decide, what is involved and what the main risks are, at the start, and keep optional modules visually separate. Test the draft with someone outside the study team before it goes to the ethics committee.
Every consent form needs a version number and date that appear on the form itself. When the protocol changes, the form changes, and participants already enrolled may need to see the new version. Decide in advance how amendments will be tracked and who is notified.
In Capture
Once the form is approved, participants can read and sign on their own device. The participant acknowledges the legal-binding statement and signs on screen, verified through a two-step process that includes an email one-time-code confirmation. The investigator or authorized site staff countersign with password re-authentication and a meaning statement, and the document is fully executed only after countersignature. Each signature is linked to the exact document content at signing time, and the signed consent exports as a PDF with signature data, timestamps and the audit trail.
Meaning of signature
I have reviewed this adverse event and confirm the assessment of seriousness, severity and causality.
Signer
Dr. A. Ozola, PI
Password
••••••••••
Pick a starter template, adapt it and run it as participant and investigator in the free sandbox. No credit card.
Process
Open the consent template library and choose the template closest to your study type. Copy it as a working draft.
Work down the section table, answer each prompt in plain language and note the protocol section it came from.
Add the modules that apply, such as biobanking or wearable data, and remove those that do not.
Have the investigator, the data protection contact and someone from outside the team read it for accuracy and clarity.
Send the draft to your ethics committee or IRB with the protocol, and revise as they request.
Put the approved text in the eConsent flow, test participant and investigator signing in the sandbox, then go live when the approved version is ready.
Before submission
No bracketed prompts left in the text.
Visits, procedures and risks checked against the current protocol version.
Read by a non-specialist; jargon explained.
Optional samples or data uses are separate choices.
Version number and date visible, with a change log.
Country and institution requirements confirmed with your ethics committee.
Participant and investigator signatures tested end to end.
A tool or template that helps you assemble a consent form from standard sections. You still adapt every section to your protocol, and your ethics committee reviews the result.
This template is a drafting aid, not legal advice. Whether a form meets the requirements of your regulator, ethics committee and country is decided by them and your sponsor.
Yes. The library at /templates/consent includes basic clinical trial, biobank and repository, genomic research, international multi-site, long-term follow-up, minimal-risk exempt, observational study, pediatric assent, pre-screening and ePRO enrollment templates.
On screen, after acknowledging the legal-binding statement, with email one-time-code confirmation. The investigator then countersigns with password re-authentication, and the document is fully executed only after countersignature.
Yes. Optional witness co-signature and legally authorised representative signature are supported.
Yes. The sandbox is free with every feature, no credit card and no time limit. You pay only when you go live with real participants.
Keep exploring
Consent templates
Ten starter templates.
How to write an eConsent form
Writing guide.
eConsent software for clinical trials
Signing and countersigning.
Digital informed consent software
The digital workflow.
Decentralized trial consent template
Remote study elements.
Institutional review board
Who reviews the form.
Starter templates and verified e-signatures. Free sandbox, no credit card, pay only when live.