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10 Steps to Clinical Study Startup: Step 6 - Initiate the Clinical Trial Agreement (CTA)

by Jae Chung
16Apr2018

The clinical trial agreement (CTA) can go by other names, such as the contract, the budget, or Investigator Commitment. The CTA is a mandatory business, legal, and financial element and, like many other documents in the clinical trial startup process, it is often responsible for substantial site activation delays of days, weeks, or even months.

10 Steps to Clinical Study Startup: Step 6 - Initiate CTA

Recent research conducted by the KMR Group based on the analysis of 20,000 contracts showed that over a 4-year period contract cycle times have doubled, with oncology and emerging markets amongst the worst performers.

Contract Cycletimes

The CTA is a legal binding agreement between the sponsor and the site. It assigns important functions between sponsor and site such as: allocation of risk, responsibilities, obligations, and financial commitments.

It also serves to protect both parties with regard to academic, legal, and intellectual property rights.

Executing the CTA

The CTA includes the sponsor and site, and may also include a CRO in which case the document will outline the same parameters for CRO involvement. Because ultimate responsibility at the site rests on the principal investigator, usually the PI must sign the CTA.

Sponsors leverage template CTAs that they use with every site. They may have different templates for different kinds of institutions (e.g. independent research site, academic institution, site network, etc.) The contracting process begins when the site receives the template contract from the sponsor.

Following site review of the CTA template, one of two things may happen:

  1. they sign and return it to the sponsor for full execution; or
  2. they redline their requested changes and return the edited version to the sponsor for approval.
Barry Milton
BARRY MILTON
Head of Business Operations
Novartis
"Contracts continue to be the roadblock in the SSU process! Significant work has decreased overall timelines with the use of MSA’s and standard language clauses. This has allowed us to refine our understanding of the process roadblocks and determine if it is an in-house problem with us as the Sponsor (i.e. delayed signatory processing) and at which department or if it is a site related issue which we were not aware of (personnel/process changes). This level of transparency provided by goBalto Activate allows us to mitigate internal and external issues before they happen keeping us focused on the work not the overall cycle time."

Roadblocks and remedies in CTA execution

Like any legal document, there are many potential points of contention within the CTA. Indemnification, insurance, intellectual property, and budget are some of the hot spots for both sponsors and sites.

Typically, sites are not compensated throughout the startup process, so completion of regulatory work before they are certain they can afford to work on the study would be a marked misuse of resources. It is common practice for most sites to request the budget and CTA prior to completing the regulatory submissions for the Institutional Review Board (IRB). It is reasonable for the site to want to confirm that the study will be equitable for them.

However, due to internal sponsor or CRO SOPs, it is not uncommon for the CTA and budget to follow the regulatory pack weeks later. This delivery method may impede efficient CTA processing. While it was commonplace for sites to accept the initial language in the CTA, as well as, the budget offered, the increasing complexity of sites and institutions has increased the negotiation timelines affecting the overall study startup.

With these aforementioned issues in mind all parties involved would benefit if the CTA was delivered in an editable, electronic format from the person with whom negotiations will eventually take place. Ideally, this would be done immediately after the site has been approved for activation. It does not hurt to send the CTA even earlier in the study startup process. If delivery is done prior to the pre-study visit, and the site does not agree to the terms, the sponsor can minimize the loss of dollars and time spent in the study startup process. Recognizing the site's need to negotiate these documents and facilitating that process for them will ensure that sponsor has done what they can to minimize delays due to contracting.

10 Steps in Clinical Study Startup

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