By Jody Ingebritsen-Howe - Manager, Clinical Research Contracts & Compliance, PFS Clinical
This article does not create any attorney client relationship. No part of this article constitutes legal advice. You are advised to seek legal advice from your attorney.
It’s no secret that clinical trial agreement (CTA) negotiations can get complicated. To make the entire process more efficient, you should consider using a CTA negotiation playbook. When we refer to a playbook, we’re talking about a document which dissects the common provisions in a CTA. It can come in lots of different forms, which we’ll dive into a little later, but a playbook is basically an outline, a chart, or an annotated agreement which breaks down each CTA topic. This type of tool should provide guidance to you and your negotiators and be helpful whether you’re looking at a company’s template for the hundredth time or seeing one for the very first time.
Setting up a good playbook for yourself will help your negotiations be as successful and efficient as possible; it might give your negotiators a specific breakdown of your required language and non-negotiables, it might provide you with examples of preferred language, and it should identify for your negotiators what language is either unacceptable or would require additional approvals in order to be acceptable. This type of tool can be extremely helpful for effective CTA negotiations, but it can always help quite a bit with other types of contracts as well, such as business associate agreements, investigator-initiated trial agreements, confidentiality, material transfer, and data use agreements, to name a few.
A playbook can be a useful tool, and there are many benefits to having one. They can improve negotiation efficiency and produce a more streamlined process for your CTA negotiators. Using one will give you the ability to focus legal resources on more complex issues and delegate negotiations. Additionally, playbooks can be used as a training tool for new staff and to develop better negotiators. Breaking down a contract according to provisions and topics can make complex agreements much less intimidating for new staff and can help established staff make time for training during their otherwise busy days. It can also help established staff bring up provisions which are common areas of contention, so your entity can improve processes or better describe rationale for their position.
Having a playbook to maintain, update, and research can give you additional responsibilities to delegate to senior staff, which can encourage their professional growth and development. You can use the playbook itself as a checklist for whatever internal requirements you might have. For example, if your signatory requires written proof for the coverage of certain topics, like subject injury compensation, you can have your negotiators identify which provision subject injury compensation is covered in and the page number as they progress through the project, The playbook itself can be provided to the signatory when the contract is routed for signatures. Similarly, if your Institutional Review Board (IRB) requires the coverage of certain topics, you can use the playbook “checklist” to fill out your IRB’s or regulatory team’s forms when you’re ready to send to them. If the playbook is used in this fashion, you can save it with the actual contract in your study file and use it for audits, when necessary.
The playbook can also be extremely helpful for tracking policy changes and industry trends. Playbooks should constantly evolve with the industry, so you’re not operating with outdated information. If our clients don’t come to us with a playbook of their own, we set one up in a pretty standard fashion, and then add dated notes in another color as we work on negotiations and get necessary approvals from clients. Those colorful notes jump out at us, so we know what needs to be discussed with our clients. Over time, we get a good sense of whether a specific approval was based on a one-time/special situation, or whether this matter seems to be an industry trend. If it’s an industry trend, discussing this with key players at your entity will help you and the entire team stay current and informed.
When used correctly, CTA playbooks can have a few different functions and can generally make negotiations and internal training and development easier. Look for part two of this blog, “Creating and Using a CTA Negotiation Playbook: Implementing a CTA Playbook” in early 2019.