Clinical trials approved under the directive

• Directive 2001/20/EC
• GCP executive order
• Act on Medicinal Products

According to the Danish GCP executive order, the sponsor is responsible for the conduct and quality of a clinical trial of medicines in humans, and the sponsor must ensure that the trial is planned and conducted in accordance with good clinical practice, and that data is registered and reported according to procedures that assure the quality of every aspect of the trial.

All clinical trials of medicines in humans have either been completed or transitioned to the Regulation. Trials approved (and completed) under the Directive are subject to the above legislation.

Issues of special focus on trial completion:

• According to section 89(2)(4) of the Danish Medicines Act, trial results must be posted in the EudraCT database as soon as possible and no later than one year after the end of the trial, making them publicly available in the EU Clinical Trials Register.

• According to sections 17 and 18 of the GCP executive order, the sponsor and investigator must keep a TMF covering relevant documents and relevant material etc. pursuant to schedule 2 of the executive order. The documents, etc. must be recorded, processed and stored so as to enable verification of all steps in the clinical trial and ensure the confidentiality of information about the trial subjects.

  The sponsor and investigator must ensure that the TMF is stored for at least five years after the end of a clinical trial.

• For trials conducted under directive 2001/20/EC, section 5(1)(viii) of the Danish GCP executive order provides that the sponsor, in the case of deviations from good clinical practice (ICH E6), must ensure that steps are taken to ensure the quality of the trial and that in the case of serious or repeated deviations, the Danish Medicines Agency is notified.

The requirement to report serious or repeated deviations still applies if the deviations are discovered during the compilation of trial data. These deviations must also be reflected in the study's final report.

Any deviations should be sent to Send an email