Contracts and trial agreements
Trials conducted under regulatory agencies require contracts between the trial site and the clinical study sponsor or organization. To ensure that all parties have a clear understanding of the definitions of legal terms, the contract should be written in plain language, allowing all parties to understand their rights and obligations.
Good clinical trial contracts help to ensure the sustainability of a trial site and guide how research will be conducted at the site. The goals of contract negotiations are to clearly agree on the responsibilities of each party, including in the event that something goes wrong.
Contracts should cover items that involve sponsor goals, including that data collection is complete and accurate, protection of confidential information and intellectual property, and compliance with the current applicable laws and regulations. Contracts should also cover the trial site goals, which are compensation for their work, authorization to publish the results of the study or be otherwise acknowledged, and coverage for any subject-related injury during the study.
The tasks, deliverables, and responsibilities of the trial site should be clearly written and detailed so that there is no confusion about what is required to conduct the study. When reviewing the contracts, things to pay attention to include capitalized terms, words that limit the actions or rights of one party, and words that are not understood. The contract should contain a definitions section.
To initiate the discussion about the feasibility of conducting a trial in a particular site under the leadership of a particular investigator, a non-disclosure agreement (also called confidentiality agreement) may be necessary. The objective of such an agreement is to protect the rights of the study designers and sponsors. The agreement must be fully executed (that is, signed by all relevant parties) prior to the study being activated and is required by sponsors of clinical trials before releasing protocols to potential site principal investigators.
The contract of Clinical Trial Agreement (CTA) (also known as a Clinical Trial Research Agreement [CTRA] or Clinical Study Agreement [CSA]) is a legally valid document that manages the relationship between the body that is providing the study drug or device, the financial support and /or proprietary information and the institution that is providing data and/or results, and publication. The essential components of a successful CTA are summarized here:
It is important to have a CTA for allocation of risk, responsibility, funds, obligations, and the protection of academic, legal, intellectual property and integrity. A CTA should describe responsibilities, terms of collaboration, requirements for payment and reimbursement, publication and intellectual property terms, indemnification and or insurance, subject injury coverage, guidelines for dispute resolution, grounds for termination of contract. The document format and initial content should allow the possibility of amending contract terms in the future. For sponsored programs, it is important to involve the designated sponsored program officer as soon as you have received essential documents such as the protocols and template CTA.
It is important to review the template for monitoring, adverse event reporting, clinical supplies and accountability, requirements for invoicing if applicable, payment disbursement, study close out and data archiving terms. Some of these terms may be negotiable. Negotiating clinical trial agreements is a routine and important activity for clinical trial sites conducting research. Although all parties involved share the same goal of initiating trial enrollment, the contract must reflect their collective, and sometimes differing, needs, which can make the negotiation process complex and time-consuming.