BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte) and PEI (Paul-Ehrlich-Institut) provided supplementary recommendations to the guideline on management of clinical trials during COVID-19 released by the European authorities on 20th March 2020.

Key points of BfArM and PEI recommendations on remote source data verification procedures (rSDV) in Germany:

  • rSDV should only be considered in exceptional cases and only to the extent necessary.
  • rSDV requires written approval by the investigator and the site. In Germany approval by the regulatory authority and ethics committee is required as well. In the application the planned rSDV approach needs to be described, starting with a study-specific risk assessment. This risk assessment can be part of the study protocol (Quality Control and Quality Assurance section) or an appendix to the protocol.
  • SOPs and study-specific documents (those on risk-based quality management and monitoring) need to be adapted accordingly.
  • The method chosen for rSDV (the EMA guidelines lists three options) depends on the infrastructure of the sites. In the application for approval, the sponsor shall list all rSDV methods which may apply because only the ones submitted can obtain approval.
  • For each rSDV method, the source document/data made available under rSDV, as well as information on precautions taken to preserve confidentiality of data and privacy of trials subjects must be provided.
  • The guidance then lists specific information required for each of the 3 rSDV approaches. It also covers requirements for document management systems and telemedicine. Additional data protection considerations may apply.

For more details, please see the official communication from the Paul-Ehrlich-Institut.

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