Are electronic signatures enforceable?

Yes. Electronic signatures are enforceable under the federal ESIGN Act (15 U.S.C. ch. 96) and state UETA statutes where adopted, provided the transaction demonstrates intent, consent, attribution, and retention capability.

When is a HIPAA BAA required?

A Business Associate Agreement is required if the party receiving or processing protected health information is not a covered entity; include BAA terms to satisfy HIPAA privacy and security obligations.

Who may sign on behalf of an organization?

An authorized representative with signatory authority must execute the agreement; institutions commonly require a designee from legal or contracting offices to confirm corporate authority.

Do clinical agreements require notarization or witnesses?

Not generally required for contract validity, but some institutions or states may require notarization for local acceptance; check state-specific requirements and institutional policies.

How to amend an executed agreement?

Execute a written amendment signed by authorized parties that references the original agreement, the changed provisions, and the effective date of the amendment.

What if a party breaches the agreement?

Remedies depend on the contract terms: negotiate cure periods, follow dispute resolution clauses, and consider indemnity, insurance, or regulatory reporting obligations as applicable.

Electronic Signature
Templates
Legal
Clinical Trial Agreement Form

Clinical Trial Agreement Form

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CLINICAL TRIAL AGREEMENT

This Clinical Trial Agreement ("Agreement") is entered into as of Effective Date: by and between Sponsor Name: and Site/Institution Name: .

RECITALS

WHEREAS, Sponsor is engaged in the development of the investigational product identified as: ; and

WHEREAS, Site is a clinical research institution capable of conducting clinical investigations under applicable laws and regulations and has the qualified personnel and facilities to conduct the clinical trial described herein; and

WHEREAS, the parties desire to set forth their respective rights and obligations with respect to the conduct of the clinical trial titled: (the "Study").

NOW THEREFORE, in consideration of the mutual covenants and agreements set forth below, the parties agree as follows:

1. DEFINITIONS

Capitalized terms used in this Agreement shall have the meanings set forth below or where defined elsewhere in the Agreement. "Confidential Information" means non-public technical, business or financial information disclosed by one party to the other that is designated as confidential or that reasonably should be understood to be confidential. "Protocol" means the written clinical study protocol attached as an Exhibit and incorporated herein.

2. SCOPE OF STUDY

Sponsor shall provide the Protocol, investigational product, regulatory documents, and applicable training. Site shall conduct the Study in accordance with the Protocol, this Agreement, the applicable investigator brochure, Good Clinical Practice, and all applicable laws and regulations.

3. INVESTIGATOR AND SITE OBLIGATIONS

Site shall ensure that the Principal Investigator holds the qualifications required by the Sponsor and applicable law, shall obtain and maintain Institutional Review Board/Independent Ethics Committee approval, obtain informed consent from all participants, maintain accurate trial records, and permit monitoring and audits by Sponsor or its designee. Principal Investigator Name: .

4. SPONSOR OBLIGATIONS

Sponsor shall provide sufficient investigational product for the Study, safety reporting requirements, protocol amendments, monitoring personnel, and reasonable financial support as set forth in Section 5. Sponsor will comply with applicable regulatory reporting and will notify Site promptly of any safety or regulatory actions that affect subject safety or the conduct of the Study.

5. PAYMENT AND BUDGET

Study Budget and Payment Terms

Total Maximum Obligation to Site: . Payments shall be made within days of submission of properly documented invoices.

6. CONFIDENTIALITY

Each party shall maintain in confidence all Confidential Information disclosed by the other party and shall not disclose such Confidential Information to third parties except to personnel who have a need to know and are bound by confidentiality obligations no less protective than those set forth herein. The obligations of confidentiality shall survive termination of this Agreement for a period of five (5) years, except for trade secrets which shall be protected for as long as they remain trade secrets under applicable law.

7. INTELLECTUAL PROPERTY

Background intellectual property shall remain the sole property of the party that owned it prior to the Effective Date. Subject inventions conceived solely by Site personnel in the performance of the Study shall be owned by Site, subject to Sponsor's license rights as expressly set forth herein. Sponsor shall own data and results generated by the Study, subject to Site's rights to use de-identified data for internal training or regulatory compliance as set forth in the attached Exhibit.

8. PUBLICATION

Site shall have the right to seek publication of aggregate Study results. Site shall provide Sponsor with a copy of any proposed manuscript or abstract at least sixty (60) days prior to submission to allow Sponsor to review for confidential information or patentable inventions. Sponsor's review shall not unreasonably delay publication.

9. INDEMNIFICATION

Sponsor shall indemnify, defend and hold Site and its officers, employees and agents harmless from and against any claims, liabilities, losses or expenses arising out of Sponsor's negligence, willful misconduct, or breach of this Agreement, except to the extent such claims arise from Site's gross negligence or willful misconduct. Site shall indemnify Sponsor to the extent claims arise from Site's negligence or breach.

10. INSURANCE

Each party shall maintain insurance appropriate to its obligations under this Agreement, including professional liability insurance covering the conduct of the Study. Upon reasonable request, each party shall provide evidence of such insurance to the other party.

11. TERM AND TERMINATION

This Agreement shall commence on the Effective Date and shall continue until completion of the Study unless earlier terminated as provided herein. Either party may terminate this Agreement for material breach by the other party upon thirty (30) days written notice if the breach remains uncured. Sponsor may terminate for convenience upon sixty (60) days written notice, subject to payment for work performed and reasonable close-out costs.

12. NOTICES

All notices required or permitted under this Agreement shall be in writing and delivered to the addresses below by certified mail, national overnight courier, or hand delivery. Notice to Sponsor:

Sponsor Contact

Notice to Site:

Site Contact

13. AMENDMENTS

Any amendment to the Protocol or this Agreement must be in writing and signed by authorized representatives of both parties. Protocol amendments required for subject safety may be implemented promptly, with retroactive execution of a written amendment as soon as practicable.

14. WAIVER

Failure or delay by either party to exercise any right or remedy shall not constitute a waiver. Any waiver must be in writing and signed by the waiving party.

15. COUNTERPARTS

This Agreement may be executed in counterparts, each of which shall be deemed an original and all of which together shall constitute one instrument. Signatures provided by electronic means shall be deemed original for all purposes.

16. GOVERNING LAW

This Agreement shall be governed by and construed in accordance with the laws of the State or Jurisdiction specified below without regard to conflict of laws principles.

Governing Jurisdiction

17. ENTIRE AGREEMENT; SEVERABILITY

This Agreement, together with the Protocol and all exhibits and attachments expressly incorporated herein, constitutes the entire agreement between the parties with respect to the Study. If any provision of this Agreement is held invalid or unenforceable, the remaining provisions shall remain in full force and effect.

ADDITIONAL PROVISIONS

Entity Type (check all that apply)

Sponsor Contract Research Organization (CRO) Site/Institution

Special Terms or Additional Notes

Sponsor:

Printed Name:

By (Signature):

Date:

Title:

Site/Institution:

Printed Name:

By (Signature):

Date:

Title:

What the Clinical Trial Agreement Form Is and Why It Matters

The Clinical Trial Agreement Form is a contractual instrument that documents the relationship between a trial sponsor, investigative site, and any contract research organizations (CROs). It sets study scope, participant protections, budgets, payment milestones, intellectual property rights, liability and indemnity, regulatory responsibilities, data handling, reporting obligations, and termination conditions. In the United States this document interacts with IRB approvals, informed consent requirements, and applicable federal and state rules; properly executed agreements reduce regulatory risk and clarify operational duties across study stakeholders.

Why a Complete Agreement Reduces Operational and Legal Risk

A clear Clinical Trial Agreement minimizes disputes, aligns sponsor and site expectations, protects participant data under HIPAA, allocates liability and costs, and documents regulatory responsibilities required for IRB review and compliance with federal rules.

Who Typically Prepares and Signs This Agreement

Multiple parties prepare and rely on the Clinical Trial Agreement to run and govern a study.

Study Sponsors and Sponsors' Legal Teams — negotiate budget, IP, indemnity, reporting, and regulatory deliverables for the protocol.
Investigative Sites and Site Administrators — confirm staffing, facilities, patient protections, billing, and local approvals.
Contract Research Organizations (CROs) and Coordinating Centers — accept operational duties, data handling, monitoring, and subcontractor terms.

Accurate completion ensures the study can start, billing can proceed, and regulatory submissions reference consistent contractual terms.

Core Components to Include in a Professional Agreement

A robust Clinical Trial Agreement covers commercial, legal, operational, and regulatory elements so all parties understand expectations and liabilities.

Study Scope

Protocol identification, objectives, enrollment targets, study phases, and a clear description of investigational product and procedures to be performed at the site.

Budget & Payments

Detailed payment schedule, milestones, invoicing procedure, allowable expenses, payment timing, and responsibilities for participant-related costs and insurance.

Regulatory Duties

Responsibilities for IRB/ethics approvals, reporting adverse events, safety monitoring, IND/IDE obligations, and maintaining required trial documentation.

Data Privacy

Data ownership, use rights, de-identification, storage, transfer, and HIPAA compliance including whether a Business Associate Agreement is required.

Intellectual Property

Ownership of inventions, background IP disclosures, license grants, publication rights, and any obligations regarding invention reporting.

Liability & Termination

Indemnification clauses, insurance requirements, limits of liability, termination triggers, transition assistance, and post-termination responsibilities.

Essential Data Elements to Capture

Agreement Parties: Full legal names

Effective Date: MM/DD/YYYY

Study Identifier: Protocol ID or NCT number

Payment Terms: Amounts and schedule

Contact Information: Authorized signers

Data Handling: Storage and access

Step-by-Step: Completing the Agreement Form

Follow these core steps to prepare, review, and execute the Clinical Trial Agreement accurately and efficiently.

01

Prepare Draft: Populate protocol, budget, and site data.
02

Internal Review: Legal and finance review for clauses and costs.
03

IRB Alignment: Confirm IRB submissions and required attachments.
04

Execute: Collect signatures and distribute executed copy.

Configuring an Online Workflow for This Agreement

Set up fields, signer order, and authentication options to support secure electronic execution and auditability.

Field	Configuration
Signature Type	eSignature or digital signature (PKI) based on audit requirements
Authentication	Email link, SMS code, or advanced ID verification
Routing Order	Sequential or parallel signer flow
Audit Trail	Capture timestamps, IPs, and actions

Where to Send and How the Routing Works

Typical submission flow moves from sponsor to site, then to legal and finance for execution and distribution.

Sponsor Upload: Sponsor uploads final draft and fields
Site Review: Site completes its designated fields
Signatures: Authorized signers execute in order
Distribution: Executed copies sent to all parties

Digital Signing and File Formats to Support

Use a platform that supports PDF and DOCX, audit trails, and required authentication methods for clinical records.

File Formats: PDF, DOCX supported
Authentication: Email, SMS, or advanced identity
Integrations: EHR, document storage, and ERP

Typical Timelines, Milestones, and Critical Deadlines

Key dates must be tracked in parallel with IRB approvals, budget milestones, and regulatory reporting obligations.

Contract Execution Before Enrollment:

Agreement signed before first participant enrollment

IRB Approval Precondition:

IRB approval must precede any study activity

Payment Milestones:

Invoices submitted per agreed schedule after milestones

Adverse Event Reporting:

Follow sponsor and FDA timelines for SAE reporting

Renewal or Amendment:

Amendments executed before changed activities commence

Common Preparation Mistakes to Avoid

Incomplete budget schedules or missing invoice requirements lead to delayed payments and reconciliation disputes between sponsor and site.
Ambiguous IP or publication clauses cause disagreements over authorship, invention ownership, and commercialization rights after study completion.
Failing to include data privacy or BAA terms results in noncompliance with HIPAA when protected health information is processed or shared.
Missing or incorrect signatory authority and inconsistent legal names trigger administrative holds and require re-execution of the agreement.

Consequences of an Incorrect or Incomplete Agreement

Regulatory Risk: IRB noncompliance

HIPAA Exposure: Civil penalties and corrective action

Financial Delay: Withheld payments

Liability Claims: Indemnity disputes

Study Delays: Enrollment pauses

Contract Voidance: Re-execution required

eSignature Pricing and Feature Comparison Relevant to This Agreement

Comparing common vendor starting prices and feature signals for executing Clinical Trial Agreements electronically; signNow is shown first per the comparison format.

	signNow	DocuSign	Adobe Sign	PandaDoc	HelloSign
Starting Price	$8/user/mo	$15/user/mo	$14/user/mo	$19/user/mo	$15/user/mo
Free Trial	7-day free trial, no credit card	Varies by vendor	Varies by vendor	Varies by vendor	Varies by vendor
Bulk Send	Yes	Yes	Yes	Yes	No
Audit Trail	Yes	Yes	Yes	Yes	Yes
HIPAA Compliant	Yes	Yes	Yes	No	No
Envelope Cap	No cap	100 envelopes/user/year	No cap	No cap	No cap

Frequently Asked Questions About the Clinical Trial Agreement Form

Answers to common legal, procedural, and technical questions when preparing or signing a Clinical Trial Agreement in the United States.

Need help? Contact support

Are electronic signatures enforceable?
Yes. Electronic signatures are enforceable under the federal ESIGN Act (15 U.S.C. ch. 96) and state UETA statutes where adopted, provided the transaction demonstrates intent, consent, attribution, and retention capability.
When is a HIPAA BAA required?
A Business Associate Agreement is required if the party receiving or processing protected health information is not a covered entity; include BAA terms to satisfy HIPAA privacy and security obligations.
Who may sign on behalf of an organization?
An authorized representative with signatory authority must execute the agreement; institutions commonly require a designee from legal or contracting offices to confirm corporate authority.
Do clinical agreements require notarization or witnesses?
Not generally required for contract validity, but some institutions or states may require notarization for local acceptance; check state-specific requirements and institutional policies.
How to amend an executed agreement?
Execute a written amendment signed by authorized parties that references the original agreement, the changed provisions, and the effective date of the amendment.
What if a party breaches the agreement?
Remedies depend on the contract terms: negotiate cure periods, follow dispute resolution clauses, and consider indemnity, insurance, or regulatory reporting obligations as applicable.

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