Golden Rules within Clinical Research

Our golden rules in pdf format:

  • Provide you a clear and practical guide to the conduct of clinical trial.
  • Are specially designed to different roles or area.
  • Contain the most essential aspects of GCP.
  • Contain best practice in the conduct of clinical trial.
  • Contain examples of inspection findings (e.g. FDA, EMA, MHRA) when the golden rules were not followed.

Implementation guides for updated GCP

The updated ICH GCP Guideline (GCP Addendum)  E6 (R2) became final in November 2016.

It provides an unified standard for the mutual acceptability of clinical trials globally and supersedes the previous ICH GCP guideline E6 (R1).

It encourages the implementation of more efficient approaches to clinical trial design, conduct, oversight, recording and reporting while continuing to ensure human subject protection and reliability of trial results.

GCP addendum was developed to address the increased scale, complexity, and cost of clinical trials. It includes the advances that have been made in electronic data recording and reporting technologies, as well as the implementation of other approaches such as:

  • Risk-based quality management
  • Risk-based monitoring
  • Requirement for oversight by investigators and sponsor when delegating and outsourcing respectively.

The changes have impact on both sponsors and investigators, but greatest impact on sponsor.

PharmaGCP provides implementation guides for investigators and sponsors. The guides contain all the changes and recommendations for how to implement the changes.

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