Contracts & Agreements

The purpose of the Contracts and Agreements stop is to establish the contracts and agreements needed to clarify study conduct and payment expectations between sites, sponsors and vendors.

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Description

Clinical trial contracts are legally binding agreements that outline the responsibilities of all parties involved in the trial.

This description is concise and accurate, and it provides a good overview of the purpose of clinical trial contracts. It is also specific enough to be useful in a Lucidchart, where it could be used to create a diagram or flowchart of the clinical trial contract process.

Here are some of the key considerations in clinical trial contracts:

  • Scope of work: The contract should clearly define the scope of work for each party involved in the trial. This includes the responsibilities of the sponsor, the investigator, and study vendors.
  • Payment terms: The contract should specify the payment terms for each party involved in the trial. This includes the amount of payment, the schedule of payments, and the payment method.
  • Intellectual property: The contract should specify the ownership of intellectual property that is developed during the trial. This includes data, inventions, and publications.
  • Confidentiality: The contract should specify the confidentiality obligations of each party involved in the trial. This includes protecting the privacy of patient data and trade secrets.

DCT-specific Considerations/Inputs

Consider implications of DCT solutions on grants (SCRS Best Practices and Responsibilities). For example assessments may not be conducted at a traditional trial site, which may change the fee structure. The PI retains oversight for these assessments. 

Per the EMA recommendation paper on DCTS: When the sponsor selects a service provider and the investigator is not involved in the contractual arrangement with this service provider, the contract between the sponsor and the investigator should clearly document the contractual arrangements with the service provider if it concerns tasks under investigator’s responsibility. This allows the investigator to agree or not to the deployment of service providers for certain trial specific tasks related to the medical care of trial participants.

Sites may require more time and or resource to use new technologies or services in a DCT trial. This needs to be clearly documented and accounted for in the contract.

Contract specifying payment based on assessment performance and PI oversight

If a meta-site / virtual site model is in use, clear contractual language about PI oversight, sub-contracting (if any) with sub-investigators, insurance, etc.

Tools

ACRP Budgeting Tool (Pending)

Regulatory Documents

FDA/U.S.

U.S. FDA Final Guidance Document: Conducting Clinical Trials With Decentralized Elements Guidance for Industry, Investigators, and Other Interested Parties - September 2024

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U.S. HHS - Engagement of Institutions in Human Subjects Research (2008)

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U.S. FDA Guidance - Payment and Reimbursement to Research Subjects

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Europe/EMA

Regulation (EU) No 536/2014 of the European Parliament on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC

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Questions and Answers Document – Regulation (EU) 536/2014 – Version 6.1, May 2022

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Reference Documents

Best Practices and Recommendations for Site Participation in Decentralized Trials

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