REGISTRY SNAPSHOT: State Institute for Drug Control (SÚKL)

by Staff writer,
Posted on 8/13/2019

clinical trial transparency disclosure requirements of every clinical trial registry globally, including the State Institute for Drug Control (SÚKL) prague praha czech republic consultant services vendor software cro company freelance expert

Prague, Czech Republic

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 State Institute for Drug Control (SÚKL). Here is an overview of this registry:

Registry name: State Institute for Drug Control (SÚKL)

Country: Czech Republic

Year established: 1952; began publishing approved clinical trial information in 2007

Points of interest:

  • The SÚKL falls under direct control of the Ministry of Health.
  • One of the main missions of SÚKL is to ensure that all human pharmaceuticals available on the Czech market meet quality, safety, and efficacy standards.
  • The Clinical Trial Application can be completed in either Czech or English.
  • Informed consent, protocol synopsis, and patient information must all be supplied in Czech.
  • The sponsor must report to the Competent Authority within 90 days of the trial’s termination.
  • In addition to the clinical trials database, the SÚKL website contains databases for medicinal products and pharmacies.
  • SÚKL was originally founded in 1952, but began publishing approved clinical trial information in 2007 in accordance with section 99 par. 1 indent f) (2) of Act No. 378/2007 Coll., on Pharmaceuticals and on Amendments to Some Related Acts (Act on Pharmaceuticals).
  • Within one year after termination, the sponsor must submit an annual study and safety report to the Competent Authority and Ethics Committee.

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