GCP Investigator Training

An NHS Client had identified clinical researchers in their Trust involved in phase II - III studies. On examination of the study site teams, it was evident that over 80% of the personnel had little or no GCP training and some sites had started recruitment.



Klinikos was asked to provide GCP training but to emphasise the practical side so that study personnel understood Adverse Event Reporting, Informed Consent (IC), Essential Document filing, Source Document Verification (SDV), etc.

Outcome

Klinikos tailored 1 and 2 day courses for Investigators and research nurses/study site co-ordinators to focus on the key elements of GCP but specifically made the course interactive with case studies and practical sessions to involve the participants enabling them to think and understand the issues in a clinical trial.

Criteria for success (Key words – GCP training, audience participation)

After running 8 separate training courses with a total of 67 delegates, trends emerged from each group when asked to summarise issues identified having now been on the course:

• Potential under reporting of AE/SAEs
• Poor documented training records
• Poor understanding of Source Document Verification (SDV)
• Poor understanding of issues with Informed Consent (IC)

In particular Principal Investigators did not realise the consequences of this role after the GCP guidelines became law in 2004.

Invariably the comments after the courses had one main theme – “I wish I had this training before I started my studies”.