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Developed in collaboration with the Joint Task Force for Clinical Trial Competency, core competency domains are designed to standardize competence expectations for the clinical research workforce and support professional development throughout the career life cycle of all professionals.
Encompasses study management and GCP compliance; safety management (adverse event identification and reporting, postmarket surveillance, and pharmacovigilance), and handling of investigational product.
Encompasses all elements of communication within the site and between the site and sponsor, CRO, and regulators. Understanding of teamwork skills necessary for conducting a clinical trial.
Encompasses how data are acquired and managed during a clinical trial, including source data, data entry, queries, quality control, and correction and the concept of a locked database.
Encompasses care of patients, aspects of human subject protection, and safety in the conduct of a clinical trial.
Encompasses the principles and practice of leadership and professionalism in clinical research
Encompasses knowledge of how drugs, devices, and biologicals are developed and regulated.
Encompasses knowledge of scientific concepts related to the design and analysis of clinical trials.
Encompasses content required at the site level to run a study (financial and personnel aspects). Includes site and study operations (not encompassing regulatory/GCPs).
Lack of Standardized Competence Putting Clinical Trials at Risk
Competency Standards Key to Elevating Clinical Trial Profession