CCRPS provides clinical research certification through ACCRE, ACPE, ANCC, AMA accredited courses for clinical research associate certification, clinical research coordinator certification, and clinical research assistant certification online. Describe the ICH GCP protocol including FDA 21 CFR, E2A, 5,5 E6, and Ethics. Explain the Quality GCP training complements other required training on protections for human research participants. Since June 2000, the NIH Extramural Research Program has required training on protections for human research participants for all NIH-funded investigators and individuals responsible for the design or conduct of a research involving human subjects. 2 Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety and well-being of trial subjects are pro- Good clinical practice (GCP) guidelines are an internationally recognized standard for clinical trials that include ethical and quality requirements that must be adhered to for any clinical trial that involves people. It specifies good clinical practice guidelines for all aspects of a study, from trial documentation and protocol amendments to The NIH GCP training policy is part of a multi-faceted NIH initiative to enhance the quality, relevance, feasibility, efficiency, and transparency of NIH funded clinical trials through stewardship reforms (see Hudson KL, Lauer MS, Collins, FS. Toward a New Era of Trust and Transparency in Clinical Trials. JAMA. 2016; 316(13):1353-1354). The principles of GCP help assure the safety, integrity Good practice in research (summary) Research is vital to improving the health of the population. In this guidance we explore how you can make sure that you apply the principles of good medical practice to your research, whether it involves people, human tissue or is records-based. Following this guidance will help make sure that participants do .

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