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. 2016 Mar 11;50(4):480–486. doi: 10.1177/2168479016635220

Table 1.

Summary of Current Landscape of GCP Training Programs.

Literature Review
Findings
  • GCP training is an important way to safeguard the integrity of clinical research.

  • In the past 10 years, many different training programs have been developed.

  • Heterogeneity in the content and expectations of GCP training programs may have introduced inefficiencies to initiation of clinical research.

  • Clarifying GCP training goals for the research community will help to streamline GCP training practices.

  • Online GCP training has the benefits of flexibility and convenience.

  • Some programs are tiered or differentiated based on job function.

Sample Training Programs
Content
  • All training programs include core elements of GCP from the investigator section of ICH E6.

  • Most training programs also include supplementary elements, such as institutional administrative processes and history of GCP.

Frequency Format Evidence of completion
Variable, typically ranging from 1 to 3 years
  • Online or web-based

  • Instructor-led

  • Mentored

End-of-course quiz with passing grade, certification or transcript, or qualification test to opt out of training

Abbreviations: GCP, Good Clinical Practice; ICH, International Conference on Harmonisation.