whether was adequate supervision and involvement in the ongoing conduct of the study, and whether there was adequate supervision or oversight of any third parties involved in the conduct of a study to the extend such supervision or oversight was reasonably possible. Investigators should maintain a list of all research staff, their delegated study task(s), the training they received that qualifies them to perform the delegated tasks, and the time period they performed these tasks. HOW do you use it? Create a log that documents the date, type of training and a complete description of the topics covered during the training session. Training can be documented for each individual or by training session. do you put it? If a sponsor provides a Training Log, file as instructed. Otherwise, the log may be filed in a Regulatory Binder stored in a location that is easily accessible and available to reference and update as needed.
whether was adequate supervision and involvement in the ongoing conduct of the study, and whether there was adequate supervision or oversight of any third parties involved in the conduct of a study to the extend such supervision or oversight was reasonably possible. Investigators should maintain a list of all research staff, their delegated study task(s), the training they received that qualifies them to perform the delegated tasks, and the time period they performed these tasks. HOW do you use it? Create a log that documents the date, type of training and a complete description of the topics covered during the training session. Training can be documented for each individual or by training session. do you put it? If a sponsor provides a Training Log, file as instructed. Otherwise, the log may be filed in a Regulatory Binder stored in a location that is easily accessible and available to reference and update as needed.
training_log_how_to.docx