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MHRA Guidance: Good Clinical Practice for Clinical Trials

Earlier today (27 September 2022) MHRA released updated guidance on Good clinical practice for Clinical Trials where they had updated information related to updated CAPA guidance.

Guidance on good clinical practice has been produced by the International conference on harmonisation of technical requirements for registration of pharmaceuticals for human use (ICH).

Good clinical practice (GCP) is a set of internationally-recognized ethical and scientific quality requirements that must be followed when designing, conducting, recording, and reporting clinical trials that involve people.

To ensure compliance with GCP, MHRA:

  • asks trial sites to notify them of serious breaches

  • carries out inspections of trial sites where serious breaches are reported

  • carries out inspections of trial sites that sponsor clinical trials, mostly based on a risk assessment

  • carries out inspections of sites when companies apply for marketing authorisations

Click this LINK to know more about Good Clinical Practice.


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