Improved access to patient data in clinical trials for monitors and GCP inspectors

01 July 2016, Updated 05 September 2016

The Danish Medicines Agency’s inspectors have direct access to health information in patient records in all clinical trials on medicinal products notified from 1 July 2016.

As a result of the new Danish act on clinical trials of medicinal products, the Danish Medicines Agency’s GCP inspectors now get direct access to health information in patient records in connection with the GCP inspectors’ monitoring of clinical trials.

The Danish Ministry of Health has announced that the amendments to the Danish Medicines Act do not apply to clinical trials notified before 1 July 2016. The previous rules apply to clinical trials notified before 1 July 2016.

The Danish Committee Act has also been amended as regards the sponsor’s, monitor’s and investigator’s access to obtain the required health information.

Information from the Danish Ministry of Health:

Pursuant to act no. 620 of 8 June 2016, a number of amendments are made to e.g. the Danish Committee Act (act no. 593 of 14 June 2011) and the Danish Medicines Act (Consolidated Danish Medicines Act no. 506 of 20 April 2013), including the rules governing the sponsor’s, the sponsor’s representatives’, the investigator’s and the Danish Medicines Agency’s access to information in patient records.

The Danish Minister for Health is authorised to determine the date of commencement of the act. The majority of the act will take effect simultaneously with Regulation no. 536/2014 of 16 April 2014 on clinical trials on medicinal products for human use, which is expected to enter into force in October 2018. However, some of the amendments to the Danish Committee Act and the Danish Medicines Act will take effect on 1 July 2016, see section 36(2) of act no. 620 of 8 June 2016. This applies to the following amendments:

  • Amendment to section 3(3) of the Danish Committee Act. According to the applicable section 3(3), any required health information and other confidential information about the trial subject can be disclosed and assessed as part of the required self-inspection and quality control, which the sponsor and monitor are obliged to conduct, provided that the trial subject has consented to this. The access to disclose information is amended to a direct access to health information in patient records. This means that the sponsor, the sponsor’s representatives and the investigator have direct access to patient records etc., including electronic records, to view information about the health status of the trial subject that is required for self-inspection of the research project, including quality control and monitoring that they are obliged to conduct. As today, this access is subject to the trial subject’s consent.

  • A new section 89(2) has been added to the Danish Medicines Act. The new provision gives the investigator, the sponsor and the sponsor’s representatives direct access to health information in patient records. They have access to information about the trial subject’s health status that is required for the conduct of the research project, including quality control and monitoring that they are obliged to conduct. This access is subject to the trial subject’s consent.

  • Section 90(5) of the Danish Medicines Act has been amended. According to the previous section 90(5), disclosure and processing of information about trial subjects' health status and other purely personal matters and otherwise confidential information may take place without the consent of the trial subject as part of the Danish Medicines Agency's inspection pursuant to section 90(2)-(4). The access to disclose information has been amended so that the Danish Medicines Agency has direct access to information in patient records etc., including electronic records. The agency has access to information about the trial subject’s health status that is required for the Danish Medicines Agency’s inspection under section 90(2)-(4).

The amendments to the Danish Committee Act and the Danish Medicines Act, see section 36(2) of act no. 620 of 8 June 2016, which takes effect on 1 July 2016, do not apply to clinical trials notified before 1 July 2016. The previous rules apply to clinical trials notified before 1 July 2016.

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