Good Statistical Practice – Tailored GCP Training for Statisticians

This Good Statistical Practice training has been developed by the UKCRC CTU Statisticians Operations Group and was funded by the NIHR Clinical Trials Unit Efficient Trial Conduct Funding scheme.

It is a suite of 5 training modules which has been developed as stand-alone GCP training tailored to statisticians, incorporating relevant regulatory aspects in the first module. It is primarily intended as a resource for statistics teams to access for group training where discussion can pull in local practice, but has also been formatted to enable self-led training through the inclusion of additional notes.

An associated publication of the training overview and development process is under review and will be circulated across the Network once in press.

The modules are:

Module 1 – Core Good Clinical Practice training
Module 2 – Record keeping and documentation
Module 3 – Trial design, randomisation and blinding
Module 4 – Data Management
Module 5 – Statistical analysis and reporting

The project lead, Prof Deborah Stocken of the Leeds Clinical Trial Research Unit, said:

“I would like to thank my co-authors for their commitment in bringing these resources together, the statisticians from across the Network and NIHR who took part in piloting and providing feedback on the individual modules, and specifically the Network’s Statistics Operations Group who instigated the project. We are also grateful to NIHR Learn and the MHRA for their engagement and support. We hope all statisticians involved in clinical trials and medical research will find these resources helpful”.

A webinar providing the background to the project, the process that was taken in developing and piloting the resources, and the training modules themselves can be accessed via NIHR Learn.