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. 2021 Sep 22;6(1):e20. doi: 10.1017/cts.2021.853

Table 4.

Guideline evolution: overall agreement (Kappa) by guideline sequence

Guideline version Batch Kappa (p-value) Guideline revision based on adjudication
0 (none) 1A 0.161* (p = 0.045)
  • Distinguished between a qualified/not-qualified applicant resumes

  • Defined transferrable skills

  • Defined key terms: clinical role/setting, clinical experience, clinical research experience

  • Set requirements for clinical experience and academic preparation by level

1 2 0.453 (p < 0.001)
  • Revised years of clinical experience by level

  • Categorized academic degree as scientific/health-related field or nonscientific/non-health-related field

  • Refined clinical research coordinator (CRC) 2, 3, 4-degree requirements, years of clinical research, and clinical experience requirements

  • Required clinical research certification for a CRC 4

2 3 0.407 (p < 0.001)
  • Updated glossary examples of clinical settings, clinical experience by job titles, and clinical research experience

  • Revised years of experience in clinical roles and years of clinical research experience

  • Developed categorization of foreign-trained MD and bench (laboratory) research personnel

3 4 0.555 (p < 0.001)
  • Removed clinical role/setting experience requirement from CRC 2–4 and required a minimum of 1-year clinical research experience for those with a scientific degree

  • Revised laboratory (bench) scientist requirements

  • Removed academic experience as a research assistant unless it involved over 1000 contact hours. Rationale: academic experience was typically data entry or participation in a component of the research project but not full engagement in a project

4 5 0.608 (p <0.001)
  • Increased the number of years required for a laboratory (bench) researcher

5 1B 0.593 (p < 0.001)
  • Final guidelines

*

Kappa computed for Raters 1 and 2 for Guidelines 0 (Batch 1A), Kappa computed for 3-Raters for remainder of development.