Clinical Trial Agreements: A Primer
A clinical trial agreement (CTA) between an industry sponsor or CRO and a research site is a legal document that outlines the rights, responsibilities, and obligations of the various parties involved in a clinical trial. It typically includes the following elements:
- The title of the clinical trial.
- The roles and responsibilities of each party, including the sponsor, the research site, and the investigator.
- The rights and obligations of each party, including their obligations to protect the rights and welfare of the study participants, to adhere to the study protocol, and to maintain the confidentiality of the study data.
- The compensation and reimbursement terms for the research site, including any fees for participating in the trial, any costs associated with conducting the trial (such as the cost of study drugs or devices as applicable), and any additional payments for achieving certain milestones or completing certain tasks.
- Publication rights will be defined. Typically, the sponsor retains the right to publish first through a multi-center publication and individual sites can publish their own results after that. The ability to publish Study results free of the Sponsor’s editorial control is a requirement for nonprofit academic medical centers.
- The intellectual property rights associated with the study, including who will own the data and any inventions resulting from the study.
- Indemnification language included in CTAs allows each party to protect itself from damages and claims that are more appropriately borne by the other party. Typically, a research site will seek indemnification from a study sponsor for any claims arising from the study which are related to the investigational product, a research procedure or the Sponsor’s use of the study data. Sponsor’s will seek to limit indemnification by ensuring that it does not apply to any damages caused by the research site’s inappropriate activities such as negligence, willful misconduct or failure to comply with applicable law.
- Research sites expect sponsors to pay for injuries that result from use of the investigational product and the performance of research procedures. Compensation for injury language is included in the research subject’s informed consent form and should be consistent with the language negotiated by the research site in the CTA.
- Use of Protected Health Information. Sponsors will include language in the CTA requiring sites to have research subjects provide written consent and HIPAA authorization that allows their Protected Health Information to be shared with the sponsor and other parties such as the Institutional Review Board (IRB) for purposes of the trial. Research sites will negotiate language to ensure that the sponsor and its representatives do not use such information except as specifically authorized by the research subject in writing.
- Payment terms are negotiated in the CTA. The payment terms include not only the amount that will be paid but also the timing of those payments. Research sites typically negotiate the payments terms to ensure that the Sponsor is required to make payments in a timely manner based on when services are actually provided.
- The terms of the agreement, including its duration, any termination provisions, and the governing law and jurisdiction.
It is important for all parties to carefully review and understand the CTA before signing it, to ensure that their rights and obligations are clearly defined and that the agreement is fair and equitable.
The Research Site’s Responsibilities
The research site is responsible for conducting the clinical trial in accordance with the study protocol, applicable regulations, and the clinical trial agreement. This typically involves the following tasks:
- Identifying and recruiting eligible participants for the trial.
- Obtaining informed consent from the participants, in accordance with applicable laws and regulations.
- Administering the study interventions (e.g., the study drug or placebo) and collecting data on the participants’ health status and response to the interventions.
- Ensuring the quality and integrity of the data collected during the trial.
- Complying with sponsor monitoring requirements and, when applicable requests for audit made by regulatory authorities
- Reporting any adverse events or other safety concerns to the sponsor/CRO, the IRB and regulatory authorities if applicable.
- Complying with the terms of the CTA, including any reporting.
- Retaining study documents for the period required by applicable law. Some sponsors may require the research site to retain documents beyond the period required by applicable law.
In addition, the research site may be responsible for providing any necessary support or services to the participants, such as coordinating transportation to and from study visits, providing medication management, or offering psychological support. It is important for the research site to have trained and experienced staff who can effectively carry out these tasks and ensure the safety and wellbeing of the trial participants.
Intellectual Property in Clinical Trials
In a sponsored clinical trial, the sponsor typically owns the intellectual property rights associated with the study, including the study data and any resulting inventions. The sponsor also retains the ability to publish study results. This means that the sponsor has the right to use and disclose the study data and publications as they see fit, subject to any confidentiality or other agreements that may be in place.
The research site may have limited intellectual property rights in sponsored trials, depending on the terms of the clinical trial agreement and any other applicable agreements.
For example, the CTA may grant the research site the right to use the study data for certain purposes (such as conducting additional research or publishing articles) subject to the sponsor’s approval.
Reviewing the CTA
The clinical trial agreement (CTA) is a legally binding contract. As such, all parties should carefully review and understand the terms of the CTA before signing it.
Typically, the CTA is reviewed and negotiated by representatives from the sponsor or CRO, and the research site. The research site may also involve their legal counsel and other relevant staff, such as the principal investigator or the study coordinator, in the review process.
While the IRB is not involved in the review of the CTA, the CTA may have certain requirements or expectations related to the conduct of the trial, such as the need to report any adverse events or safety concerns to the IRB. The CTA should be consistent with the regulatory requirements. Regardless of the CTA, the research site must report to the IRB any unanticipated problems involving risks to subjects or others as well as any modifications to the research before they are implemented.
In addition, the CTA may also be reviewed by regulatory authorities, such as the FDA, to ensure that it complies with applicable laws and regulations.
Amending the CTA
Any changes to the CTA must be made in accordance with the terms of the agreement and with the consent of all parties.
Amending the study protocol often results in an amendment to the CTA which may include amendments to the study budget. Typically, the CTA will include provisions for making changes to the agreement, such as a requirement for the parties to consult and negotiate in good faith, or a requirement for the parties to agree to amending the CTA in writing.
Filing the CTA
Final copies of the fully executed CTA should be stored in a secure network or cloud-based system that is accessible only to authorized personnel.
In addition to storing the fully executed CTA, the research site should also maintain copies of any amendments or modifications to the agreement, as well as any related correspondence or documents. These copies should be filed and stored in a manner that is consistent with the original CTA, to ensure that all relevant information is easily accessible.
It is important for the research site to maintain accurate and complete records of the CTA and any related documents, to ensure that they can easily retrieve and review the agreement as needed. This will help the research site to fulfill its obligations under the CTA and to protect its rights and interests.