11/27/2018

The regulations require investigators to have appropriate qualifications, but how to define it is not thoroughly described. Generally, sponsors or CROs have chosen to define qualification as completing training on Good Clinical Practice (GCP). Although having a knowledge of GCP is essential, the current method of training is not effective. Common deficiencies from FDA investigator inspections are related to GCP principles. The new recommendations from Clinical Trials Transformation Initiative (CTTI) require a shift in perception of what it means to be qualified to how prepared investigators and the site staff are.

The recommendations suggest a shift in perception of qualification:

Instead of GCP training before every trial, consider the site staff’s preparedness to conduct that particular study.
Evaluate skills and knowledge before site selection and during the clinical trial.
Investigators and the site staff need to take ownership of their own qualification and preparation.
A prepared site has a support system and qualifications beyond GCP.
Conduct an individualized assessment of what the site and/or investigator need to be successful for each clinical trial.

The recommendations suggest an update to evaluating training needs:

Conduct a risk analysis for potential challenges to the protocol and include common deviations in sites for similar protocols.
Perform a gap analysis of what skills and knowledge the site staff have.
Targeted goals for protocol and role specific learning should be developed when assessing skills and knowledge.
Educational needs are based upon individual protocol challenges and what skills and/or knowledge the gap analysis finds are lacking.
Allowing for additional resources to evaluate the site’s readiness and allowing for transparency in the assessment will create a higher quality trial and reduce the need for issues management down the road.
Once the gap is identified, provide for quality relevant learning experiences.
The site can document previous relevant learning experiences and application of knowledge and skills, updating as needed.
The sponsor or CRO should accept this as documentation of qualifications.

The CTTI recommendations suggest thinking outside traditional training. Each site staff member may have a different learning style and would benefit from an individualized method of adult learning. More active learning experiences such as mentoring, shadowing, knowledge-sharing networks, mock run throughs, and on-line educational offerings can be more effective in improving skills and knowledge gaps, reducing risks, and improving quality in clinical trials. Investigator qualification is much more than retraining GCP for each new study and involves the whole site in ownership of preparedness.

- The Clinical Pathways Team

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