Fundamentals of Clinical Research Delivery

By Jon Davies, Research Nurse, CRN West Midlands (CRN WM) and Good Clinical Practice (GCP) Facilitator

Last year the National Institute of Health Research (NIHR) released a new training course called “Fundamentals of Clinical Research Delivery”, which members of the CRN WM primary care GCP facilitator working group have recently amended to make more relevant to primary care.

Fundamentals training is intended for members of staff who will not have freedom to act in a research study.

In other words, it is for staff who will only be peripherally involved or occasionally assisting in a study, e.g. Health Care Assistants or Practice Nurses (PNs) who are performing routine clinical procedures for research purposes and, as such, do not need full study or GCP training. Primary Care Fundamentals is an approximately two-hour course delivered in-house, and certificates are provided.

Fundamentals does not replace full GCP training for staff who will have freedom to act in a research study, e.g. lead study GPs or PNs, and this will depend on the type of study and as directed by the study Sponsor.

Fundamentals has further been amended in primary care as a research awareness course to make it more relevant to non-clinical practice staff who work in research active practices, e.g. receptionists, administrators etc. This course takes one hour, is delivered in-house, and certificates are provided.

The research courses provided by the CRN WM are as follows:

· Full GCP training (either in-house or online)

· GCP Refresher (in-house or online)

· NIHR Fundamentals for Primary Care training (in-house only)

· Primary Care Research Awareness Training (in-house only)

· Informed Consent training (in-house)

If you wish to find out more please ask your local research facilitator or research nurse who should be able to assist you, see Participate for details, contact the CRN Workforce Development team or Jon Davies direct on jonathan.davies@nihr.ac.uk