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GCP-aligned development

ICH-GCP Competency Assessment

Beyond definitions — develop competency with judgment calls GCP is written to guide. A private, applied assessment informed by ICH E6 principles.

  • Scenario-based, not multiple-choice trivia
  • Rubric informed by ICH-GCP principles
  • Covers consent, source data, safety, deviations, and IP accountability
  • Free, private, and takes about five minutes
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Quick answer

An applied ICH-GCP competency assessment tests whether you can act consistently with Good Clinical Develop Competency under realistic pressure — not whether you can recite the guideline. The Competency Labs assessment is informed by ICH-GCP principles and widely used competency frameworks. It is independent and not affiliated with, endorsed by, or accredited by ICH or any regulatory authority.

DefinitionAn ICH-GCP competency assessment is a structured diagnostic that estimates a candidate's applied understanding of ICH-GCP principles — informed consent, protocol adherence, source documentation, safety reporting, and sponsor/site responsibilities.

Applied domains covered

  • Informed consent process and re-consent triggers
  • Source documentation and ALCOA-C data integrity
  • Protocol adherence, deviations, and reporting
  • Adverse event and SAE identification, grading, and reporting
  • Investigational product accountability
  • Delegation of authority and training documentation
  • Essential documents and TMF completeness

Why applied assessment matters

GCP violations rarely stem from ignorance of the text — they stem from the gap between reading a guideline and using it under time pressure with imperfect information. Applied assessment closes that gap by measuring judgment on realistic scenarios.

Framework note

The rubric is informed by ICH E6 principles and the Joint Task Force for Clinical Trial Competency domains. Competency Labs is independent and is not affiliated with ICH, ACRP, SOCRA, IAOCR, FDA, EMA, MHRA, or any regulatory body.

What this is not

Clear boundaries so you know exactly what Competency Labs does and does not claim.

  • Not an official ICH-GCP certification and not accredited by ICH, FDA, EMA, or MHRA.
  • Not equivalent to formal GCP training required by sponsors, IRBs, or ethics committees.
  • Not an employer-recognized credential and not a job guarantee.
  • Not a legal or regulatory attestation of compliance.

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Competency Labs is an independent platform. Our simulations and competency rubrics are designed to align with recognized clinical research competency frameworks, ICH-GCP principles, and global regulatory expectations. Competency Labs is not currently affiliated with, endorsed by, or accredited by IAOCR, ACRP, SOCRA, ICH, FDA, EMA, MHRA, Health Canada, TransCelerate, MRCT, ISO, or any regulatory authority unless expressly stated in a formal written partnership or accreditation notice. Learn more.