All About CTAs: Navigating the Details
Acronyms abound in the health life sciences industry. What is a CTA (clinical trial agreement) and how does it impact your site’s clinical research processes? Also known as a clinical research agreement, a CTA is a binding document that defines legal and payment requirements that will apply to the conduct of the trial and several associated vital components.
CTAs cover the allocation of risk, responsibility, funds, obligations, as well as the protection of academic, legal and intellectual property and integrity between the site and sponsor during the course of a clinical trial. To prevent any undue legal harm to patients and the clinical research program itself, thorough review and negotiation of this agreement is necessary.
When reviewing research agreements, there are several sections that require additional focus and attention: subject injury, indemnification, insurance limits, payment terms, payee information and governing law. While this list is not exhaustive, focusing on these sections provides guidance for the development of a contract that works in the best interest of your research program.
1. Subject Injury
Aim to broaden the language in the interests of the patients and make the language congruent with the Sponsor-approved Informed Consent Form. What is relayed to the patient must mirror the contractual obligations. Avoid words like “direct” or inhibiting which type of injury would be covered as there are numerous unknown variables.
Indemnify means to guard or secure against anticipated loss; to give security against future damage or liability. Essentially, this is a clause in which a party agrees to protect the other against potential harms or losses that the other party may occur.
A clause in the CTA which states that the sponsor will indemnify, defend and hold the site and its employees harmless is considered a best practice in order to safeguard your organization from liability.
3. Insurance Limits
Assure this section mirrors your certificate of insurance regarding the amounts and term.
4. Payment Terms
Clearly define the payment terms of the relationship between the site and sponsor in the clinical trial agreement. This document will outline payment remittance details for the study, so you will want to ensure payment terms are comprehensive and allow for billing compliance within your institution. During this process, look for and remove phrases such as “payments are conditional on volume of subjects enrolled,” or “payments are conditional on results.”
5. Payee Information
This section should reflect your current W-9 entity name, address, and tax ID#. If automatic payments, be sure to include accurate bank account information.6. Governing Law
Often, the CTA will mention which state law will govern the terms of the agreement. Best practices indicate that clinical research sites should insert the state in which you are conducting the clinical trial, or that both parties agree to remain silent.
Initiating trials is resource intensive and carefully reviewing the CTA to ensure that the correct information is included protects your site’s interests. GuideStar Research industry leaders have strong financial backgrounds that support effective negotiation for research sites within hospital or healthcare systems. Learn more about how we can help.
Post by Melissa Daley -
Melissa develops social media and marketing content strategies and produces a variety of collateral with creative, effective messaging. Melissa has served as an educator in higher education for close to two decades.