Notification of serious or repeated non-compliance with good clinical practice in clinical trials

25 August 2010, Updated 03 January 2014

Serious or repeated non-compliance must immediately be notified to the Danish Medicines Agency under section 5(8) of the Danish executive order on GCP. The sponsor must make sure that any such non-compliance is notified.

Serious non-compliance

Serious non-compliance is a deviation which may affect the trial subjects' safety or rights or the data credibility.

The following list includes examples of non-compliance, which the Danish Medicines Agency expects to be reported:

  • The investigator or other involved parties (e.g. the Contract Research Organisation – CRO) has not reported SAEs (serious adverse events) or SUSARs (suspected unexpected serious adverse reactions), and this lack of reporting can influence the safety profile of the product.
  • Substantiated suspicion (e.g. after completed audit) on manipulation of data (fraud).
  • Systematic deviations, such as errors in connection with the informed consent process, randomisation, blinding procedure, adverse reaction assessment, reporting, etc.
  • Systematic deviations across sites.
  • Dosage errors, e.g. based on misinterpretation of laboratory data, miscalculations, etc.
  • The sponsor stops the trial, e.g. while potential safety issues are investigated.
  • The sponsor decides to close down a site out of consideration for trial subject safety or data quality.

Repeated non-compliance

Repeated non-compliance is deviations occurring despite corrective and preventive action, and which are collectively believed to potentially influence trial subject safety or rights or the data credibility.

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