Drug Evaluation Committee 2019-06 Clinical Trial-Specific Training for Implementing Medical Institution Personnel
Related classification: Other
Date of first publication: 2019-06
Question
What are the training log records for global clinical trials?
Training at the start of a clinical trial and training records at the time of revision of the study protocol, but I thought that the investigator determines the extent to which training should be provided to those involved in the clinical trial and records it. The sponsor told me that since it is not specified in the GCP, the investigator is not supposed to keep a record of training.
For example, if the criteria for drug withdrawal is changed, I think that the investigators and CRCs need to be trained, but do the investigational drug managers and laboratory technicians who process specimens also need to be trained and record the training?
Opinion of the Pharmaceutical Manufacturers Association
Personnel involved in the conduct of a clinical trial must meet the requirements to adequately perform their duties through education, training and experience (GCP Article 1 Guidance 2 (8)). This education and training includes training specific to the clinical trial, such as the content of the study protocol. In addition, the investigator is responsible for providing sufficient information, guidance and supervision of the investigators, subinvestigators and collaborators regarding the protocol, the investigational product and their respective duties (GCP Article 43.2 Guidance 1). Therefore, it is desirable to keep a record of the investigator's training, as the investigator is responsible for ensuring that the investigative staff has received sufficient training.
Since the protocol is a document that describes the method of the trial, it is necessary that all trial staff members have received training. Therefore, even when the protocol is revised, all clinical trial staff should basically be informed and training records should be kept as proof that the information is known to all. However, there should be no problem if the training content is set individually according to the job description of the clinical trial staff in order for them to perform their job properly.