ECRPTQ Competencies

ECRPTQ Domains

There are 8 competency domains:

  • Scientific concepts and research design: Knowledge of scientific concepts related to the design and analysis of clinical trials
  • Ethical and participant safety considerations: Care of patients, aspects of human subject protection and safety in the conduct of a clinical trial
  • Medicines development and regulation: Knowledge of how drugs, devices, and biologicals are developed and regulated
  • Clinical trial operations: Study management, GCP compliance, safety management, and handling of investigational product
  • Study and site management: Site and study operations
  • Data management and informatics: How data are acquired and managed during a clinical trial
  • Leadership and professionalism: The principles and practices of leadership and professionalism in clinical research
  • Communication and teamwork: All elements of communication within the site and between the site and sponsor.  Teamwork skills necessary for conducting a clinical trial.

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