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