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.
The benefits of a CTA Playbook are plenty, and its many uses make it a great tool for contract negotiators. Getting to use the playbook is a task in itself, so take the following implementation suggestions into consideration.
One recommendation for playbook implementation is that you absolutely do not set it up alone. Make sure the individuals who will be using the playbook have a chance to see it and ask questions before anything is set in stone. Before it is finalized, make sure all questions are addressed. Send it for approvals to any individuals or departments that may be helpful to get some input from (legal, clinical, finance, compliance, risk management). You will ideally already have worked with these individuals or departments when setting everything up; if that’s the case, this might just be verifying that you captured their input accurately. If they weren’t involved by this point, it might be beneficial to ask them more questions and get their input and approval in a single step.
Implementation itself means dispensing the playbook, in ready-to-use form, to the negotiators. If you have a team of negotiators, be strategic about how you introduce the team to the playbook. If you have a great team that works well together, brainstorms well as a group, and helps each other out quite a bit, it might be better to do a group training of the playbook. If you don’t have this type of team, it might be better to train one senior negotiator, and have them handle individual trainings. Either way, consider designating a point-person for playbook-related questions, updates, and training of new staff. Incorporate this playbook into your training documents and processes as a whole, so your new negotiators aren’t left in the dark as to the “hows” and “whys” of your new document.
The playbook can be set up in a number of ways. Every playbook should cover: (A) provisions you’re going to see in the vast majority of clinical trial agreements (CTAs), and (B) provisions which need to be covered in a very specific way – in other words, your non-negotiables. A few examples of this are recordkeeping, confidentiality/privacy and protected health information, indemnification, and subject injury compensation. These topics should be covered, in one way or another, in the majority of CTAs, so it’s not helpful to your negotiators if your playbook says nothing about these topics. Make sure you provide either language itself that you can accept, or guidance on what is and is not acceptable on these topics.
The playbook should also cover site-specific information that your negotiators need to add to CTAs or that they should know for structural reasons. A couple common examples would be institutional entity descriptions (limited liability company, healthcare district, nonprofit organization, etc.), employment structuring (is the principal investigator a direct employee or an independent contractor; is the same true for individuals working under the principal investigator’s direction?), and your insurance coverage.
Whatever layout and format you decide to use for your playbook, there are some common elements that contribute to its success and helpfulness. The first essential element is to be detailed. If possible, include actual rationale within the playbook, so your negotiators know exactly why you can’t agree to specific language. Maybe your institution has rules around drug storage, drug destruction, or it has specific institutional review board requirements – let the negotiators know these are institution-wide rules, so they have some context during their contract discussions. Notes are often useful as rationale, so be sure to include them based on conversations with key players during drafting of the playbook.
We see both verbatim-style playbooks and overview/“gist” playbooks. There are pros and cons to each.
The benefits of verbatim-style playbooks include improved control over content, consistency between users, and ease in implementation. Some downsides of this style of playbook are that there is limited flexibility in terms of the wording that’s used, which can lead to longer negotiations lending to increased escalations and frustrations between negotiation partners. One tip for verbatim-style playbooks is to include guidance your negotiators can use to explain your language.
Overview-style playbooks are the inverse of verbatim-style playbooks in a lot of ways. Some positives of the overview-style are that there is more flexibility in the wording than its counterpart. The negotiations will be shorter and more efficient, which will lead to fewer escalations between partners. Downsides of this style of playbook are that more expertise is required. Firsthand knowledge of the subject matter is required in order to be able to implement the overview-style. It can lead to inconsistency between users and could potentially require more work up front. A tip for the overview-style playbook is to include examples of preferred language that can be used.
What we hope you take away from this is that playbooks can really streamline the negotiation process for your contracts staff. Instead of having them ask the study team with each contract, or having to ask the principal investigator, counsel, or risk managers each time certain topics arise, you can set your negotiators up for success and give them parameters for what they can and cannot accept. That being said, giving your negotiators a tool for success shouldn’t be cause for worry for your signatories – make sure it’s clear which topics may still need to be elevated for approvals, and give them guidance in playbook-format for where they can and cannot deviate.
Make sure you monitor use of the playbook over time: set frequent check-ins with your negotiation team to stay informed on topics that they’re struggling with during negotiations, areas where the industry seems to be shifting, or matters that need frequent updates. They should not be forced to work with an outdated tool, so make sure you can convey to them that either they have the ability to update it as-needed with input from necessary departments, or that leaders recognize its importance and meet with them regularly to hash out where it needs updates. Lastly, your final product is absolutely confidential and proprietary, so mark it accordingly, and keep it in-house. Make sure your negotiators know this as well, so it’s not externally shared. It should be an internal tool, not a shared policy.