This blog post will go into some detail regarding exactly what types of trainings must be conducted and how often this training must take place when it come sto clinical research staff at a site level. Furthermore, the documentation of this training will be emphasised, as we all know in research the old saying of “if it is not written, then it did not occur”.
The Site Manager is responsible for the training and documentation of training for all staff members, including but not limited to: study coordinators, PI’s, Sub-I’s, clinicians, research assistants. It is important to note that none of these aforementioned individuals will ever claim to have sufficient time to partake in necessary training, therefore it is the duty of the Site Manager to ensure that training is conducted and properly documented by all staff members associated with your site. The lack of proper training and/or documentation is the best way to get an audit, and to eventually give yourself more work by having to retrain all staff members on the proper conduct of research.
The following is a list of the types of trainings necessary and how often they should occur. Proper documentation of each training will also be explained. To find out what these trainings are, just do a search on this blog.
-GCP training: Should occur 1 time per year for every staff member. A certificate should be printed and retained in the training file. Another copy should be placed in the regulatory binder of all studies which this individual is associated with.
-NIH Protecting Human Research Subjects: Should occur 1 time per year for every staff member. A certificate should be printed and retained in the training file. Another copy should be placed in the regulatory binder of all studies which this individual is associated with.
-IATA: Should occur once every 2 years and varies per coordinator or research assistant depending on when last training occurred. Please ensure that retraining occurs before IATA expiration date or else your site will be subject to costly fines by the regulatory agencies. A certificate should be printed and maintained in training file as well as a copy being placed in the regulatory binder associated with the individual who took the training.
-HIPAA: Should occur every 2 years. A certificate should be printed and retained in the training file. Another copy should be placed in the regulatory binder of all studies which this individual is associated with.
Protocol-specific training: Should occur 1 time per year for every staff member. A certificate should be printed and retained in the training file. Another copy should be placed in the regulatory binder of all studies which this individual is associated with. Furthermore, whenever the study sponsor introduces an amendment to the protocol, a protocol retraining and proper documentation must take place.
EKG and vital sign training: Should occur 1 time per year for every staff member. A certificate should be printed and retained in the training file. Another copy should be placed in the regulatory binder of all studies which this individual is associated with.
If I am wrong on any of these, let me know, but to my knowledge, and in speaking with several monitors over the years, this type of documentation is adequate.
