The Good Clinical Practice

GCP is short for Good Clinical Practice, which is an international and scientific standard of quality in performing clinical drug experiments. The GCP units in Denmark aim at ensuring that researchers meet the requirements on Good Clinical Practice in all clinical drug research.

What the ​​GCP unit offers

The GCP unit offers counselling and a systematic review (monitoring) of trial-related activities and documents to ensure compliance with the GCP guidelines:
  • Contents of trial protocol, information about participants and declaration of consent/authorisation
  • Guidance on notification procedures
  • Appropriate preparation of trial-related documents

Detaile​​​​​​d monitoring plan

When a trial commences, the GCP units offer to monitor the trial according to a specified monitoring plan agreed together with the person responsible for the trial. The monitoring entails:

Initiation/upstart of study, e.g.:
  • Checking that all formalities and procedures are in order
  • Description of responsibilities

Monitoring, e.g.:

  • Review of patient charts/CFRs
  • Source data verification
  • Handling of the trial drugs
  • Side-effects report

Conclusion, e.g.:

  • Review of data processing
  • Filing trial-related documents according to the GCP guidelines.

Reporting, e.g.:

  • Documentation of compliance with protocols

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