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.
- Routine inspections are announced in writing to the sponsor and/or trial site three to four weeks before the planned inspection date. The announcement also asks for the submission of documents relevant to the inspection, such as the study plan, ethics reports, declaration of consent, information on the study product.
- After reviewing the requested documents, the scope of the inspection is communicated to the sponsor and/or trial site.
- The scope of the inspection depends, among other things, on the type of clinical trial and may include the inspection at the sponsor and/or trial site or the inspection at involved contractual partners of the sponsor such as the Clinical Research Organisation (CRO), laboratory, data processing, etc.
- The inspection at the trial site usually deals with study documentation, patient consent, study medication, source data comparison.
- The main focus of the inspection at the sponsor or contract partners is on the QM/QA system of the sponsor, study documentation of the sponsor, IMP management, pharmacovigilance, processes, procedures, responsibilities.
- The scope of the inspection depends on the facts found; the scope and duration of the inspection will be adapted as necessary. In the case of a registration inspection, the exact issue is defined by the experts. They may accompany inspections as experts.
- The inspection begins with an initial meeting in which the inspectors provide information on the legal basis of the inspection and the procedure.
- The inspection is always conducted as a process/system inspection. It therefore goes beyond the individual study. At the end of the inspection, a final meeting is held where the inspectors give a preliminary summary of the deficiencies found.
- Within eight weeks after the inspection, an inspection report will be sent to the party hearing in accordance with § 45 (3) AVG for knowledge and comment. The opinion of the inspected party on the
- Inspection report must be submitted to the Institute Monitoring in electronic form within a period of four weeks after receipt of the inspection report, should refer specifically to the deficiencies identified and contain corrective and preventive or already implemented measures for each deficiency, including evidence.
- Finally, the BASG prepares the final report. In addition to the original report, it contains the opinion of the inspected party and a final assessment by the FOAG of the measures proposed and implemented. If the proposed measures are not sufficient, the BASG will prescribe appropriate measures.
- The procedure is completed with receipt of the final inspection report or the specification of the measures. The implementation of the measures may be subject to a re-inspection.
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.