Submission of annual safety reports for clinical trials
Once a year, a safety report (ASR) documenting the safety profile of the trial must be submitted. The ASR must contain the evaluation and conclusion of the risk/benefit of the trial based on all SAEs and SARs observed during the reporting period and include a list of any SARs observed.
A template for an Annual Safety Report (ASR) has been developed by the GCP unit.
The period is counted from the first approval in CTIS according to Article 43(4) of the Regulation.
For submission in CTIS, further guidance can be obtained here:
The Danish GCP Units guide: The Danish GCP Units guide - Submission of Annual Safety Report (ASR) in CTIS
EMA training module no. 18: How to create and submit an annual safety report and respond to related requests for information
If the trial has risk-adapted measures, these must be described in the annual safety report. The sponsor must be aware that any serious adverse reaction (SAR) and suspected unexpected serious adverse reaction (SUSAR) reported by the investigator must be included in the annual safety report. The Danish Medicines Agency's guidance on risk-adapted adverse reaction recording and reporting in clinical trials of medicinal products under Regulation (EU) No 536/2014
The protocol for the individual clinical trial must define whether a single safety report is submitted for all investigational medicinal products used in a clinical trial, cf. Article 43(2) of the Regulation.
Under the regulation, annual safety reports per active substance can be submitted in CTIS so that they cover trials applied for under both the directive and the regulation. Simply refer to the EudraCT and EUCT numbers in the cover letter. However, the requirement is that there must be a trial in the EU with the active substance approved under the Regulation. For submission of annual safety reports to the Scientific Ethical Committee System during the transition period, we must refer to VMK.
Change log:
November 2024: Updated version of DKMA guidance on risk-adapted recoding and reporting v.2.0. (central version link).
28 June 2024 - General website update
02 June 2022 - Fixed broken links and added change log.