Improving the quality conduct and efficiency of clinical trials with training: Recommendations for preparedness and qualification of investigators and delegates

The Clinical Trials Transformation Initiative (CTTI) Investigator Qualification Project addresses the need for a more efficient and effective means of identifying qualified clinical investigators and delegates. Selection of investigators and delegates who are qualified by training and experience to conduct clinical trials is essential to safeguarding protections for study participants and ensuring data quality and integrity. Sponsors generally document investigator qualification through training on the principles of good clinical practice (GCP), as defined by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), adopted by regulatory authorities in the United States, Japan and the European Union.

Source: Contemporary Clinical Trials - December 23, 2019 Category: Radiology Authors: Jimmy Bechtel, Tina Chuck, Annemarie Forrest, Christine Hildebrand, Janette Panhuis, Suzanne R. Pattee, Sabrina Comc-Savic, Teresa Swezey Source Type: research