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!