REGISTRY SNAPSHOT: Federal Office for Safety in Health Care (BASG)

by Staff writer,
Posted on 6/4/2019

Knowing which countries to submit clinical trial results summaries to is the easy part. What becomes difficult is learning the intricacies and transparency requirements of every clinical trial registry globally, including the Federal Office for Safety in Health Care (BASG) in Austria. Here is an overview of this registry:

Trialassure transparency requirements of every clinical trial registry globally, including the Federal Office for Safety in Health Care (BASG) in Austria protocol registration results summaries disclosure software vendor services consultant

Vienna, Austria

Registry name: Federal Office for Safety in Health Care (BASG)

Country: Austria

Year established: 2006

Points of interest:

  • The BASG and the Austrian Medicines and Medical Devices Agency (AGES MEA) were established in 2006 to oversee multiple tasks, including:
    • Issues marketing authorizations for medicinal products (human and veterinary)
    • Assessing the efficacy and safety of medicinal products and medical devices
    • Conduct market surveillance
    • Inspect manufacturers
  • THE BASG is part of Austria’s Ministry of Health
  • Since 2014, sponsors must upload the final study report for in the EudraCT database, and final study reports will be made publicly available via the EU Clinical Trials Registry
  • Final study reports must be uploaded within 12 months of the global end of the clinical trial for non-pediatric trials and within 6 months for pediatric trials
  • Sponsors must fill out the EudraCT application form and corresponding documents before beginning a clinical trial – these required forms must be submitted to BASG
  • The EudraCT form should be completed in English with the exception of contact information on Austrian sponsors, legal representatives, and clinical investigators

Related transparency research/articles:

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