Clinical Trial Agreement Template

Clinical Trial Agreement Template

This Clinical Trial Agreement (the “Agreement”) is made and entered into as of [Effective Date] (the “Effective Date”) by and between:

Sponsor: [Sponsor Legal Name], [Entity Type], with an address at [Sponsor Address] (“Sponsor”).
Institution/Site: [Institution Legal Name], [Entity Type], with an address at [Institution Address] (“Institution”).

Principal Investigator (PI): [PI Full Name], [Department/Title] (the “Investigator”). The Investigator is not a party unless required by Institution policy or listed as a party below.

Sponsor and Institution may be referred to individually as a “Party” and together as the “Parties.”

1. Study Identification

1.1 Study Title. [Study Title].
1.2 Protocol. Protocol No.: [Protocol Number]; Version/Date: [Version/Date] (the “Protocol”).
1.3 Investigational Product/Device. [Name/Description].
1.4 Site Location(s). [Site Address(es)].
1.5 CRO (If Applicable). Sponsor’s CRO: [CRO Name], role: [Monitoring/Project Management/Other].

2. Purpose and Scope

2.1 Purpose. Institution will conduct the Study at the Site in accordance with the Protocol and this Agreement.
2.2 No Guaranteed Enrollment. Institution does not guarantee enrollment numbers or study outcomes.
2.3 Order of Control. If there is a conflict, this Agreement controls unless the Parties expressly state otherwise in writing.

3. Term

3.1 Term. This Agreement begins on the Effective Date and continues until the Study is completed at the Site, all required data is provided, and all payments are made, unless terminated earlier under Section 16.

4. Regulatory, Ethics, and Compliance

4.1 IRB/IEC Approval. Institution will obtain and maintain IRB/IEC approval as required and provide documentation upon request.
4.2 Informed Consent. Institution will ensure informed consent is obtained and documented before any study-required procedures, as applicable.
4.3 Standards of Conduct. The Parties will conduct the Study consistent with applicable laws and generally accepted clinical research standards (including Good Clinical Practice where applicable).
4.4 Training. Institution will ensure study staff are trained on the Protocol and study procedures before performing Study tasks.
4.5 Protocol Deviations. Institution will document deviations and report them as required by the Protocol, IRB, and applicable rules.

5. Institution and Investigator Responsibilities

5.1 Site Conduct. Institution will perform screening, enrollment, visits, follow-up, and documentation as required by the Protocol.
5.2 Qualified Personnel. Institution will ensure adequate staffing and facilities and that only qualified personnel perform Study tasks.
5.3 Delegation. Investigator may delegate tasks to qualified staff but remains responsible for oversight as required by applicable standards.
5.4 Records. Institution will maintain accurate and complete Study records and source documentation as required by law, the Protocol, and Institution policy.
5.5 Supplies and Accountability. Institution will store and account for investigational product/device as instructed, and document dispensing/return/destruction as applicable.

6. Sponsor Responsibilities

6.1 Materials. Sponsor will provide the Protocol, required study materials, and investigational product/device (if applicable) in a timely manner.
6.2 Safety Updates. Sponsor will provide safety reporting instructions and updates relevant to the Study.
6.3 Payments. Sponsor will pay Institution according to Section 11 and the attached budget.

7. Monitoring, Audits, and Inspections

7.1 Monitoring Visits. Sponsor or CRO may monitor the Study at reasonable times with reasonable notice, subject to Site access policies and patient privacy rules.
7.2 Audit Rights. Sponsor may audit Study-related records reasonably necessary to verify compliance and data quality, consistent with applicable law.
7.3 Regulatory Inspection Notice. If Institution receives notice of a government inspection related to the Study, it will notify Sponsor promptly unless prohibited by law.
7.4 Corrective Actions. Institution will cooperate in good faith to address findings and implement reasonable corrective actions.

8. Safety Reporting

8.1 Adverse Events. Institution will document and report adverse events as required by the Protocol and Sponsor instructions.
8.2 Serious Adverse Events. Institution will report SAEs within the timeframes stated in the Protocol.
8.3 Safety Contact. Sponsor’s safety contact information: [Name/Email/Phone/24-7 contact if applicable].

9. Confidentiality

9.1 Confidential Information. Non-public information disclosed in connection with the Study (including the Protocol if not public), Sponsor materials, and pricing/budget terms is confidential.
9.2 Use and Protection. The receiving Party will use Confidential Information only for the Study and protect it with reasonable care.
9.3 Permitted Disclosure. Disclosure is permitted to personnel/contractors who need to know and are bound by confidentiality obligations, and as required by law.
9.4 Exclusions. Confidential Information does not include information that is public through no breach, independently developed, or rightfully received without restriction.

10. Data, Records, and Publication

10.1 Study Data. “Study Data” includes data and results collected under the Protocol, excluding Institution’s general know-how and pre-existing materials.
10.2 Ownership and Use (Select One).
☐ Sponsor owns or controls Study Data for research, regulatory submissions, and related purposes. Institution may use Study Data for internal academic/research purposes subject to confidentiality and privacy obligations.
☐ Other: [Define clearly].
10.3 Data Entry Timelines. Institution will enter required data into Sponsor’s system within [__] days after each subject visit, unless the Protocol states otherwise.
10.4 Publication Review. Institution may publish results subject to Sponsor review to remove Confidential Information and protect patent filings. Review timeline: [30/45/60] days, plus an optional delay of up to [30/60/90] days solely for patent filing (if applicable).
10.5 No Indefinite Delay. Sponsor may not unreasonably delay publication beyond the review periods stated above.

11. Budget, Payments, and Invoicing

11.1 Budget. The Study budget is attached as Exhibit A (or “Budget”) and includes start-up, per-subject/visit fees, pass-through costs, and close-out fees.
11.2 Payment Model. Payments will be made: ☐ Per-visit ☐ Per-milestone ☐ Other: [Define].
11.3 Invoicing. Institution will invoice: ☐ Monthly ☐ Quarterly ☐ Per milestone, with reasonable supporting documentation as required by the Budget.
11.4 Payment Due Date. Sponsor will pay approved invoices within [__] days of receipt.
11.5 Screen Failures and Early Withdrawals. Payment for these is handled as follows: [Define amounts/percentages and what is billable].
11.6 Non-Cancellable Costs. Sponsor will reimburse pre-approved, non-cancellable costs incurred in compliance with this Agreement: ☐ Yes ☐ No ☐ Limits: [Define].
11.7 Taxes/Withholding. Sponsor may withhold taxes as required by law.

12. Subject Injury and Medical Care

12.1 Medical Care. Institution will provide or arrange appropriate medical care for subjects as clinically indicated.
12.2 Cost Responsibility (Choose One).
☐ Sponsor will reimburse reasonable and necessary costs for injuries directly caused by the investigational product/device or Protocol-required procedures, except to the extent caused by Institution/Investigator negligence, willful misconduct, or Protocol noncompliance.
☐ Other: [Define].
12.3 No Waiver. Nothing in this Agreement limits a subject’s rights under applicable law.

13. Intellectual Property

13.1 Background IP. Each Party retains ownership of its pre-existing intellectual property.
13.2 Study Inventions. Inventions conceived or reduced to practice in performing the Study (“Study Inventions”) are handled as follows:
☐ Sponsor owns Study Inventions related to Sponsor’s product/device, subject to Institution policy and applicable law.
☐ Institution owns Study Inventions not related to Sponsor’s product/device.
☐ Other: [Define].
13.3 Invention Disclosure. Institution will promptly disclose Study Inventions to Sponsor for evaluation, consistent with Institution policy.

14. Privacy and Data Protection

14.1 Compliance. Institution will handle subject information in accordance with applicable privacy laws and Institution policy.
14.2 De-Identification/Coding. Data shared with Sponsor will be: ☐ Coded ☐ De-identified ☐ Identifiable (only if permitted and documented).
14.3 Authorizations. Institution will obtain required authorizations/consents for data use and disclosure for the Study, as applicable.
14.4 Security. Each Party will use reasonable safeguards to protect study information and systems access.

15. Indemnification and Insurance

15.1 Sponsor Indemnification. Sponsor will indemnify Institution and its personnel against third-party claims arising from Sponsor’s investigational product/device or Sponsor’s breach, except to the extent caused by Institution/Investigator negligence, willful misconduct, or Protocol noncompliance, as permitted by law.
15.2 Institution Indemnification. Institution will indemnify Sponsor against third-party claims arising from Institution/Investigator negligence, willful misconduct, or failure to follow the Protocol, to the extent permitted by law.
15.3 Insurance. Each Party will maintain commercially reasonable insurance appropriate for its obligations.

16. Termination and Close-Out

16.1 Termination for Convenience. Sponsor may terminate the Study at the Site with [] days’ written notice. Institution may terminate with [] days’ written notice if continuing would violate law/IRB requirements or subject safety standards.
16.2 Termination for Cause. Either Party may terminate if the other materially breaches and fails to cure within [__] days after written notice.
16.3 Effect of Termination. Upon termination:

• Institution will follow subject safety and follow-up requirements as appropriate,

• Institution will return or destroy Sponsor materials as instructed (except records required to be retained),

• Sponsor will pay for work performed and approved non-cancellable costs through the termination date per Exhibit A, and

• the Parties will cooperate on orderly close-out and data reconciliation.

17. Limitation of Liability

17.1 No Consequential Damages. To the extent permitted by law, neither Party is liable for indirect or consequential damages.
17.2 Liability Cap (Optional). Total liability is capped at: ☐ Amounts paid under this Agreement ☐ $[__] ☐ Other: [Cap].
17.3 Exceptions (Optional). The cap does not apply to: ☐ Indemnification ☐ Confidentiality breach ☐ Willful misconduct ☐ Other: [Exceptions].

18. Notices

18.1 Notice Method. Notices must be sent by: ☐ Email ☐ Certified mail ☐ Courier ☐ Other: [Method].
18.2 Notice Contacts.

• Sponsor Email: [Email]

• Institution Email: [Email]

19. Governing Law and Dispute Resolution

19.1 Governing Law. This Agreement is governed by the laws of [State].
19.2 Dispute Resolution. Disputes will be resolved by:
☐ Informal negotiation
☐ Mediation
☐ Arbitration
☐ Court litigation in [County, State]
19.3 Attorneys’ Fees (Optional). Prevailing party attorneys’ fees: ☐ Yes ☐ No ☐ Limited to: [Details].

20. Miscellaneous

20.1 Entire Agreement. This Agreement is the entire agreement regarding the Study at the Site and supersedes prior discussions.
20.2 Amendments. Amendments must be in writing and signed by both Parties.
20.3 Assignment. Neither Party may assign without the other Party’s written consent, except to a successor in interest.
20.4 Severability. If any provision is unenforceable, the rest remains effective.
20.5 Counterparts; Electronic Signatures. This Agreement may be signed in counterparts and by electronic signature.

Signatures

By signing below, the Parties agree to be bound by this Clinical Trial Agreement as of the Effective Date.

Sponsor: [Sponsor Legal Name]
Title/Role: [Title]
Date: [Date]
Signature: ___________________________

Institution/Site: [Institution Legal Name]
Title/Role: [Title]
Date: [Date]
Signature: ___________________________

Principal Investigator (Optional): [PI Full Name]
Date: [Date]
Signature: ___________________________