Ask the Experts: GCP Training Requirements Dependent on Sponsor, Protocol
The FDA’s Office of Good Clinical Practice responds to inquiries on a variety of trial-related subjects, providing answers on the agency’s official regulations as well as best practices. The following is a selection of questions and answers excerpted from the CenterWatch publication, GCP Questions, FDA Answers.
Question: In sponsored studies, we all sign delegation of authority logs that provide start and stop dates for our roles. Investigators and research coordination staff sign training logs for each new protocol amendment. Do regulatory staff members need to be trained on each protocol amendment and/or investigator’s brochure for these studies? Regulatory staff do not have patient contact and their role in the study is to process the amendments and obtain regulatory approvals.
Answer: You would want to speak to your sponsor regarding specific good clinical practice (GCP) training and follow your institutional internal procedures and policies on research training.
FDA’s regulations are not explicit as to what comprises adequate training for study staff (e.g., GCP training) or how often training should be completed. Instead, FDA’s regulations broadly require that clinical investigators and study staff be qualified by education, training and experience to perform their assigned duties. Sponsors must choose qualified investigators and have discretion in determining what qualifications will be needed based on the general recognition that this would include education, training and experience pertinent to the particular clinical study and its design and execution, as well as familiarity with human subject protection regulations, recordkeeping, data integrity, and GCP standards and requirements.
FDA has a guidance document on investigator responsibilities (“Investigator Responsibilities — Protecting the Rights, Safety and Welfare of Study Subjects”) that provides an overview of the investigator’s responsibilities with respect to protecting human subjects and ensuring the integrity of the data from clinical investigations. This guidance also clarifies for investigators and sponsors FDA’s expectations concerning the investigator’s responsibility to supervise a clinical study in which some study tasks are delegated to employees or colleagues of the investigator or other third parties and to protect the rights, safety and welfare of study subjects.
Question: We have U.S. investigators that are completing human research protection training. However, they are not providing us with GCP certification or completing any further training. Is this acceptable?
Answer: FDA’s regulations do not specify how to document training for site staff nor do they specify what training is required. FDA does not offer certification in GCP nor does it offer guidelines on who performs the training.
The regulations require documentation of the investigator’s qualifications. For drug and biologic studies, the sponsor must obtain the curriculum vitae or other statement of qualifications of the investigator showing the education, training and experience that qualifies the investigator as an expert in the clinical investigation of the drug for the use under investigation. For device studies, the sponsor must obtain the investigator’s curriculum vitae and, where applicable, a statement of the investigator’s relevant experience, including the dates, location, extent and type of experience.
FDA holds the clinical investigator responsible for the conduct of the study at his or her site and, therefore, the investigator needs to ensure the qualifications and training of study staff who are delegated study-specific tasks. Such qualifications and training would need to be appropriate for the performance of the delegated tasks. Appendix E of FDA’s guidance, “Investigator Responsibilities — Protecting the Rights, Safety and Welfare of Study Subjects,” includes a discussion that addresses qualifications and training of site staff.
Question: Does GCP training expire?
Answer: Neither FDA’s regulations nor guidance provide specific guidelines on how often GCP training should be completed by principal and sub-investigators and study staff involved in investigational drug research or how the training should be documented. The expectation is that investigators and sub-investigators and study staff will be knowledgeable about GCP, including human subject protection, data integrity, recordkeeping, etc. Note that sponsors may identify in the protocol a required frequency of GCP training as well as documentation of training, in which case the investigator, sub-investigators and study staff would be expected to meet that frequency of training in order to comply with a sponsor’s requirements.
What training is needed and how it is documented depends to some degree on the nature of the study. Some protocols need extensive training and others may need minimal. It is also dependent upon the background and experience of study staff. This is probably why you don’t see expiration dates on the training documentation.