Serious or repeated non-compliance must immediately be notified to the Danish Health and Medicines Authority under section 5(7) 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 Health and Medicines Authority 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.
For further information, please contact GCP-krav@dkma.dk.
