A clinical trial agreement checklist includes the negotiation points that must be considered when creating a clinical trial agreement (CTA) and budget. If you are unfamiliar with the art of negotiation, it's important to proceed strategically, be prepared, protect your reputation, and trust in an experienced, knowledgeable professional.

Strategic Negotiation

While negotiating comes naturally to most of us, it's not always the right strategy. This is especially true when negotiating with an individual or team experienced in contracts and budgets since they will have a competitive advantage. Improve your strategic negotiating skills by considering the following before working toward a deal:

  • Creating an atmosphere that can help you reach your organization's goals.
  • Asking questions that improve your leverage.
  • Listing strong alternatives when negotiations are stalled.
  • Identifying independent standards that can be used to support your offer.
  • Identifying the next offer or concession you plan to make.
  • Taking steps to control the agenda.
  • Discussing the issues at hand in a specific order.

Frequently Asked Questions About CTA Negotiation

  • How should a sponsor be approached about annual fee changes, including the addition of new fees? How should we proceed if the sponsor cites previous contracts in which fees remained the same each year?

Provide justification for the increases to improve your negotiating position. Note the number of years and calculate inflation for that time period to show the purchasing power of the dollar. This will help the sponsor recognize that as the trial proceeds, utilities, staff, space, and other costs continue to increase. You can also cite specific financial pain points on the current or previous study. This could include unreimbursed SEAs that put the site at a loss.

  • Should IRB, advertising, and recruitment fees be included in a CTA?

While these items should not be included as overhead, you should include overhead on fees that are subject-specific, such as additionally required labs, scans, or visits.

  • How can we avoid receiving many queries with immediate deadlines after months have passed with no queries?

The contract should include a deadline for query resolution and data review. Ten business days is considered a reasonable time period.

Key CTA Concepts

The best CTAs delineate legal obligations and rights for all parties, including investigators, institutions, sponsors, and CROs. Key elements of this agreement include:

  • Adherence to updated regulatory guidelines and frameworks.
  • Protection of intellectual property so that the sponsor can market and sell the medical drug or device in question while allowing the research site to freely sublicense IP it has created in the course of the trial. Any IP should be thoroughly and accurately described in the agreement.
  • A sponsor may be required to indemnify the PI and the research institution if claims are made by clinical trial subjects. Each institution should also fully review its insurance policies to determine whether a dedicated policy is needed for the clinical trial.
  • Subjects must give their informed consent to participate in the trial. The CTA must indicate how their medical data will be collected, used, shared, and protected.
  • The type of information about the trial results and research that can be published, credits that must be given upon publication, publication timeframes, and sponsorship right to review prior to publication. Clauses about publication should consider both appropriate publication rights and patent security issues that can arise.

CTA Checklist

When completing a CTA checklist, you will likely be asked to indicate:

  • The name of the principal investigator, his or her department, the name of the trial sponsor, and the protocol number.
  • Whether the protocol has been initiated and developed by the PI or sponsor or whether it is federally funded.
  • Whether the clinical trial will focus on Veterans' Administration (VA) patients and/or be conducted at a VA facility or supported by the VA.
  • Whether the sponsor will pay for or provide protocol-related drugs and/or devices.
  • Whether you accept the IP language as written in the CTA or if modifications are required.
  • Whether you accept the publications language as written in the CTA or if modifications are required.
  • Whether the trial has been registered through ClinicalTrials.gov if required.

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