Good Clinical Practice
Good clinical practice comprises a catalogue of internationally recognised ethical and scientific quality requirements that must be complied with in the planning, conduct, recording and reporting of clinical trials on human subjects. Compliance with this practice ensures that the rights, safety and well-being of clinical trial participants are protected and that the results of clinical trials are credible [defined in EU Directive 2001/20].
In Austria, compliance with GCP is regulated in a legally binding manner by the Austrian Medicines Act, the Medical Devices Act and the GCP guideline.
For the annual inspection programme of clinical trials according to the AMG and MPG, all trials that are ongoing, completed or otherwise legally relevant for Austria must be taken into consideration.
The inspection candidates are selected in such a way that with the available inspection resources random checks of all sponsors and centres in Austria are carried out.
In the case of ongoing trials, only those trials or centres that already included patients in Austria, will be inspected.
If, according to the above principles, more inspection candidates are found than resources are available for inspection, a prioritisation according to the following criteria is possible:
- Findings during the validation and evaluation of applications
- Findings in the annual safety reports according to the AMG ("annual safety reports" or "DSURs")
- Findings during the market surveillance of medical devices
- Sponsor or centre not yet inspected
- Demanding or complex study design (e.g. "Basket Trials" or "Platform Trials")
- Findings during previous inspections
The list provides an overview of the procedures of inspections of clinical trials carried out or in progress by the BASG according to the German Medicines Act (AMG) or the German Medical Devices Act (MPG). Listed are the study title, EudraCT or Eudamed study number (if available), the sponsor of the study and inspected centres and the status of the inspection procedure (announced, performed, completed). For data protection reasons, no personal names of auditors and no inspection results are published.
The publication is primarily intended to provide transparency for patients, healthcare institutions and other interested parties.
The list is kept per calendar year and updated at the end of each quarter of the year.