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FAQ

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For which studies does the sponsor need to be recognised as non-commercial sponsor in Belgium and how should this recognition be requested?

  • Post published:26 April 2022
  • Post category:FAQ

For academic studies under the Belgian experiment law (May 7th 2004) or the Medical Device…

Continue ReadingFor which studies does the sponsor need to be recognised as non-commercial sponsor in Belgium and how should this recognition be requested?

What is the difference between an experiment and a clinical trial?

  • Post published:7 March 2022
  • Post category:FAQ

Experiment (refer to submission package and procedure for Experiments) An experiment is defined as “Every…

Continue ReadingWhat is the difference between an experiment and a clinical trial?

What is the legal period for advice from the Ethics Committee (EC) and Federal Agency for Medicines and Health Products (FAMHP)?

  • Post published:31 January 2022
  • Post category:FAQ

For experiments under the law of May 7th 2004, retrospective studies, studies on residual human…

Continue ReadingWhat is the legal period for advice from the Ethics Committee (EC) and Federal Agency for Medicines and Health Products (FAMHP)?

What are the responsibilities of the Medical Manager?

  • Post published:19 January 2022
  • Post category:FAQ

The biobank medical manager is responsible for the various responsibilities imposed by the Royal Decree…

Continue ReadingWhat are the responsibilities of the Medical Manager?

What are the responsibilities of the Principal Investigator?

  • Post published:6 January 2022
  • Post category:FAQ

According to section 4 of the International Conference on Harmonisation – Good Clinical Practice (ICH-GCP),…

Continue ReadingWhat are the responsibilities of the Principal Investigator?

How to obtain a Good Clinical Practice certificate?

  • Post published:6 January 2022
  • Post category:FAQ

HIRUZ has a GCP course available, which can be followed free of charge via POL…

Continue ReadingHow to obtain a Good Clinical Practice certificate?

What is a biospecimen?

  • Post published:9 December 2021
  • Post category:FAQ

Human biospecimens are defined as any biological material taken from a human individual for diagnostic…

Continue ReadingWhat is a biospecimen?

What is a biobank?

  • Post published:9 December 2021
  • Post category:FAQ

According to TIME magazine in 2009, biobanks were one of the ten things that were…

Continue ReadingWhat is a biobank?

End of trial reporting: who is responsible?

  • Post published:9 December 2021
  • Post category:FAQ

End of trial (i.e. the last visit of the last patient – LPLV) needs to…

Continue ReadingEnd of trial reporting: who is responsible?

Do I need to prepare a final report?

  • Post published:9 December 2021
  • Post category:FAQ

Within a year after the end of trial (i.e. the last visit of the last…

Continue ReadingDo I need to prepare a final report?
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  • HIRUZ
    • About us
    • GCP Certificate
    • News
    • Calendar
    • FAQ
  • Contract Unit
  • Clinical Trial Unit
    • Focus Team
    • Templates
    • Experiments
    • Clinical trials
    • Thesis
    • Medical devices
    • In vitro diagnostic medical devices
  • Data Management
    • REDCap features
    • Your own REDCap project
    • REDCap Walk-in
    • Clinical Data Management Services
  • Innovation & Valorisation
    • Open calls for funding
    • Research funding
    • Research valorisation
    • Industrial collaborations
  • Quality Unit
  • Patient Participation