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Essential documents Deep Dive: Agreements

Good Clinical Practice glossary series

Welcome back to the Hart GCP knowledge series. We have been reviewing essential documents that are typically generated before the clinical phase of the trial begins. We have looked specifically at the Investigator brochure,  clinical protocol/protocol amendments, informed consent tracking,  and the use of advertisements.  Today we will be reviewing financial documents and insurance required prior to beginning a clinical trial.

The Good Clinical Practice (GCP)  guideline, ICH E6 R2, doesn’t go into great detail regarding how financial agreement should be arranged, but it does state that it should be addressed.  The guideline states that financial aspects of a trial should be documented in an agreement between the sponsor and the investigator or institution (page 19), and defines a contract as a “written, dated, and signed agreement between two or more involved parties that sets out any arrangements on delegation and distribution of tasks and obligations and, if appropriate, on financial matters” (page 3).

Many research institutions have checklists for what should be included in a contract between a study sponsor and the institution.  Things that may be required to address in your agreements yet may be overlooked include:

  • Agreement that procedures will be used to protect research participants
  • Dissemination of findings—roles that investigators and sponsors will play in publications, presentations, or other disclosure of results to the medical community, regulatory bodies, and patients
  • Responsibility for medical care for research-related injuries
  • Agreements for sponsor reporting of safety issues to the institution
  • Handling of intellectual property
  • Indemnification or insurance

If required by the applicable regulatory requirements, the sponsor should provide insurance or should indemnify the investigator or institution against claims arising from the trial, except for claims that arise from malpractice and/or negligence (page25). In years past, it was virtually unheard of for sponsors in the United States to be required to purchase this type of insurance for U.S. -located studies. However, in recent years, the trend is growing for large institutions to require such a policy.

Generally, it is good business practice to have written agreements for each area that could be of value to the parties, such as intellectual property, for each area of potential liability, such as payments for research-related injuries, and for potential areas of disagreement, like dissemination of information.  It is no different for a clinical trial and the ICH E6 R2 GCP guidelines speak to the importance of having these documents in place without dictating exactly how they should be implemented.

Thank you for reading HCC’s glossary series!


Local Athlete Donates $2,000 to Operation Homefront

San Antonio (March 9, 2016) – Ben Blaylock, clinical research associate (CRA) for Hart Clinical Consultants (HCC) – a national clinical research organization (CRO) – donated $2,000 to Operation Homefront this week, a local charity providing emergency assistance to service members’ families and wounded vets. Ben received this money as a prize for earning first place in the “Hart Healthy Challenge,” an initiative by HCC during Heart Month (February) to support healthy lifestyles and give back to the communities HCC serves. Using Jawbone UP24 devices to track their steps, the team members attempted to reach and surpass daily step goals.

“The charity is near and dear to my heart, since many of my family members currently serve or have served in the military,” said Ben.

The competition not only gave Ben the opportunity to give back to his local community, but it also helped him achieve a personal goal of training for the “Alamo 13.1 Half Series” – a San Antonio half-marathon scheduled for March. Between training for the half-marathon and aiming to win the Hart Healthy Challenge, Ben lost 20 pounds in just a few weeks.

“This wouldn’t have happened without the challenge,” Ben said. “Seeing the rest of the team’s activity motivated me to surpass the step goal every day. All the walking strengthened my legs, making a huge difference in my training.”

HCC takes a personal interest in their staff and was thrilled when the team achieved a total of 3.4 million steps together. According to a study released in June 2015 by the Society for Human Resource Management, 70 percent of U.S. employers now offer some kind of employee wellness program. The trend of walking-based challenges like the “Hart Healthy Challenge” will continue to be popular in 2016, and HCC plans to organize another competition later this year.

“Everyone won something this past month by increasing their daily steps and fitness goals,” said HCC Chief Executive Officer Jim Hart. “We value the health and happiness of our employees. It was amazing to see how the competition sparked their motivation and excitement. We hope we inspired other companies to do the same.”

To learn more about HCC’s national team of medical professionals and innovative services, visit

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About Hart Clinical Consultants: Hart Clinical Consultants is a comprehensive clinical research organization (CRO), providing staff augmentation and leadership throughout all phases of medical device and pharma/IND clinical trials. HCC has an industry leading staff of senior clinical research consultants and specialists across the country that integrate directly into host environments, providing expert proctoring, training, monitoring and oversight for medical device trials. Hart Clinical Consultants has a proven history of securing thorough and timely results for such high-profile brands as Stryker, ResMed, Juventas, CardioDx and Integrium. For more information, follow @HartClinical on Twitter or visit