Christine M. Hildebrand, PA-C
Clinical Operations Lead
Amici Clinical Research
Chief Operating Officer
Population Health Research Institute
David Braley Research Institute
Improving Qualification of Investigators: Recommendations from the Clinical Trials Transformation Initiative
CTTI; Investigator qualifications; Investigator training; Site team training; Good clinical practice; Clinical trials
- There is little evidence that good clinical practice (GCP) training alone sufficiently qualifies investigators in the conduct of clinical trials. What is needed is a targeted and risk-based approach to educating clinical trial investigators and their delegates in GCP principles.
- A culture shift is needed that eliminates the distinction between “qualification” and “preparation” and moves toward investigators and their delegates assuming greater ownership of training and documenting evidence of their qualification.
- CTTI recommendations outline how to confirm that site teams are qualified while also reducing inefficiencies in training and increasing preparation for successful study execution.
Investigators and site teams come to the table with different levels of research experience, training, and credentials. How can we effectively address gaps in skills and knowledge of GCP principles?
With respect to pragmatic trials conducted within healthcare systems, are there approaches to site monitoring that address issues related to turnover of PIs and clinical and research staff?
Greater ownership of GCP training and qualification by investigators and delegates can lead to active remediation of deficiencies at the clinical site.
CTTI recommendations are meant to be adaptable to the protocol, even when conducted in a real-world clinical setting using electronic health records.
For recommendations and tools for improving investigator qualification, visit CTTI’s Investigator Qualification website.
#ClinicalTrials, #GCPtraining, #pctGR, @Collaboratory1 @CTTI_Trials