In most of the cases training in clinical research is limited to GCP training. It is true that good understanding of GCP is a critical for everyone involved in research, however is it enough?
When I started my very first job in clinical research my training included GCP and company’s standard operating procedures (SOPs). After the trainings I was allocated my first task, which was Ethics Committee submission and… I had no idea how to do that. In theory everything sounded clear enough but when I had to perform submission for specific study I didn’t know what to include in the submission, who to contact, etc. In reality this is the case with many new people who start their first job in clinical research.
Unfortunately due to the resource issues and high turnover majority of the new team members in clinical trials teams are left to “figure it out on their own”. However, this approach comes with consequences not only for the new team member but also for the whole team.
All these complications show that it is worth investing time in properly training new staff. There are few approaches that will help new team members:
It is always better to do everything correctly at the beginning instead of fixing errors on a later stage, which could cause additional stress before inspections.
Author: Olga Peycheva
Olga is a clinical research professional who has been working in clinical research since 2005. She has extensive experience in clinical research in Eastern and Western Europe.
Originally published on 2 Mar 2015