GCP Training is Not Enough to Qualify Investigators: Tips for Sponsors from CTTI
​[Thursday, December 6, 2018]

Sponsors should look beyond GCP training to identify, groom and qualify investigators for their trials. A White paper on improving measures of investigator qualifications from the Clinical Trial Transformation Initiative (CTTI), a joint non-profit venture of the FDA and Duke University, suggests sponsors avoid repetitive training and encourage investigators to improve new skills. Investigators should be trained in clinical protocol specific procedures and encouraged to expand their knowledge to areas of clinical trial other than general concepts. Repetitive GCP training should be avoided to instead focus on targeted and effective educational programs, with less redundant and burdensome training. Sponsors should recognize previous training and experience that supports the transfer of skills between studies which in turn would boost the morale of the investigators and encourage them to work collaboratively with the sponsor. The sponsor should be transparent with the investigators regarding gaps in their knowledge or skills and offer ways to fill the gaps with innovative and constructive adult learning methods. Investigators, similarly should appreciate the limitations of GCP training alone and the diverse training of their teams. Investigators should evaluate their team’s preparedness to conduct clinical research before seeking selection as a trial site. Prior to taking on a new trial, investigators should review the full clinical protocol to assess if their site is even capable of executing that protocol. Investigators should self-evaluate their performance on past protocols to develop policies, procedures, or educational programming to improve the conduct of future studies. Investigators should “seek out educational offerings that meet content-specific learning goals and suit individual learning styles”. New skills learned should ideally be applied to new trials that may need such skills. Investigators should create internal mentoring programs where more experienced members train less experienced ones. Lastly, investigators should “document learning activities, as well as the successful application of knowledge and skills pertinent to their role in conducting trials, to serve as a record demonstrating their qualification for the conduct of clinical trials.” All these tips are common sensical suggestions that should be easy to implement. However, these require enthusiastic participation from busy physicians who are trying to fit clinical trial business into their practice for obvious reasons. One can argue that the sponsors will need to do the heavier lifting to implement their suggestions at investigators they need. Otherwise, these would end-up being good suggestions that are poorly followed.