The centre’s Safety Desk has long-standing experience in supporting investigator-initiated clinical trials, be they mono-centric, multi-centric or multinational. The Safety Desk is supported by a quality assurance system, written standard operating procedures and experienced staff. We are using a pharmacovigilance database compliant with international requirements (ICH E2B). Clinical trials can thus be realised in accordance with Good Clinical Practice (GCP) and the applicable regulatory requirements, supporting patients’ safety to the best possible degree.
The Centre for Clinical Trials Münster provides the following services:
- Contributing the safety part of the trial protocol and establishing a fully functional executive structure in compliance with regulatory as well as trial specific requirements
- Safety review of the trial protocol and other trial documents
- Providing a Serious Adverse Event form
- Processing Serious Adverse Event reports (data entry into the pharmacovigilance database, MedDRA coding, follow-up and query management, organising timely assessment, narrative)
- SUSAR reporting to competent authority/ies, ethics committee/s, and investigators (CIOMS-1 form or electronic reporting)
- Reporting of other safety issues, in close collaboration with the trial’s principal investigator
- Periodic safety reporting according to current requirements (e.g. Development Safety Update Report), in close collaboration with the trial’s principal investigator
- Preparing further reports as required
- Data reconciliation between trial and safety database, in cooperation with the trial’s data management staff
- Fulfilling reporting obligations to involved manufacturers according to contract
Medical devices trials can also be supported according to applicable legal requirements concerning patients’ safety.