Working with hospitals around the country, GuideStar has expertise and has developed best practices for agreement negotiations and are excited to share some of them with you, here, to ensure that the next clinical trial for your site gets off on the right foot.
To start, let’s determine what, exactly, is a clinical trial agreement (also known as a clinical research agreement). The clinical trial agreement is the binding document that defines legal and payment requirements that will apply to the conduct of the trial.
The vital components of the CTA lie in 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. Thorough review and negotiation of this agreement is paramount in protecting your patients and clinical research program from any undue legal harm.
When reviewing research agreements, there are several sections that will require additional focus and attention: subject injury, indemnification, insurance limits, payment terms, payee info 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.
By carefully reviewing these sections of the clinical trial agreement and ensuring the proper information is included is important to your site’s best interest. As we commonly say at GuideStar, clinical research should be run like a business and that means negotiating and executing contracts that protect your site and better ensure success.
About GuideStar Research
GuideStar works with hospitals, health systems and physician practices across the country to optimize clinical research programs. From helping incorporate a clinical trial strategy to providing support services, our service delivery is based on operational and financial best practices to ensure success.
Post by Sean Walsh -
Sean brings over 20 years of Medical Management experience to GuideStar and has a key interest in strategic design and implementation of clinical research sites. He has served as an Operational Chief for multi-specialty medical centers and health systems and has vast experience integrating clinical research operations into medical practices. Sean has led an award winning clinical research site to 13 drug approvals among his many other achievements in this industry.