1. Language and Limitations
2. Site Contracting
3. Ensuring Site Protection

Clinical trial contract management is the administration of an agreement among hospitals, research investigators, and clinical trial participants. This can be challenging, especially when the study spans several countries with different regulations, cultures, languages, and customs. Experience and knowledge are essential to avoid delays in this process. Improvement of this process can lead to reduced costs and improved data quality.

Language and Limitations

Clinical trials that are subject to FDA regulations require the study sponsor and the hosting site to sign a clinical trial agreement. It's best to create a contract in plain language that is easily understandable by both parties. Legal jargon is not necessary for the contract to be legally binding. The contract should provide definitions of any legal terms used and clearly detail the site's responsibilities, tasks, and deliverables in conducting the study.

A sponsor's goals when conducting a clinical trial include:

  • Gathering accurate, comprehensive data to support their approval to market the product.
  • Protecting their intellectual property and other confidential data.

The host site's goals include:

  • Complying with laws and regulations.
  • Receiving fair compensation.
  • Receiving indemnification.
  • Being granted the ability to publish study results.
  • Coverage for subject injury that occurs as a result of the research.
  • Protection for the site.

The language of the research agreement should help ensure that both parties' goals are met. If you receive a contract that contains language that you don't understand, ask for it to be revised with a definitions section included. All capitalized words in the contract should be included in this section.

Look for limiting language such as "without limitations," "any," and "all." These words may require the site to drop everything whenever a sponsor needs something. Instead, responsibilities should be spelled out as specific, detailed expectations. For example, do not sign a contract that states that the site will use all resources available to investigate and solve any unexpected adverse event that occurs. Instead, verbiage should require prompt reporting of the event to the sponsor and a reasonable time period for alleviation, such as seven to 10 business days.

Other limiting language includes:

  • "Immediately," which should be changed to indicate a reasonable time period.
  • "Best efforts," which should be replaced with "reasonable efforts."
  • "Sole discretion" should be changed to "reasonable discretion of both parties."

Site Contracting

The costs of the sponsor in a clinical trial can be influenced by the research agreement in several key ways:

  • An agreement that is poorly negotiated or drafted can create legal risk and resultant financial liability.
  • Inefficient negotiations can lead to increased fees associated with extra work hours.
  • Delay due to these factors can cause the sponsor to lose substantial profit.

Clinical trial contracts are typically considered low risk because they are highly regulated and subject to established protocols. The parties to this type of contract are unlikely to agree to terms that could jeopardize their ethical or scientific reputations.

However, when reimbursement clauses are drafted improperly, hospitals can claim costs that are beyond the sponsor's responsibility to reimburse. Agreements with inadequate intellectual property and/or confidentiality clauses can also result in lost profit.

In most cases, when a contract issue of this type exists, most parties will want to settle in good faith to avoid jeopardizing future collaboration or attracting negative publicity.

Ensuring Site Protection

The study is prohibiting from using any study staff, vendor, investigator, or sub-investigator that is barred from performing studies by the FDA. The site is responsible for ensuring that no study staff working directly on this study have been investigated or debarred by the FDA but should not be contractually required to list the names of all staff at the institution.

The sponsor should not be given editorial rights or control over the findings of an investigator. They may only review a manuscript to ensure it does not reveal confidential information. This review should be subject to a set timeline such as 60 days by the contract.

The site should not be contractually required to retain study records for more than two years post-investigation unless the sponsor is able to provide reasonable justification for a longer retention period.

If you need help with managing a contractual agreement for a clinical trial, you can post your legal need on UpCounsel's marketplace. UpCounsel accepts only the top 5 percent of lawyers to its site. Lawyers on UpCounsel come from law schools such as Harvard Law and Yale Law and average 14 years of legal experience, including work with or on behalf of companies like Google, Menlo Ventures, and Airbnb.