For Clinical Trials of Investigational Medicinal Products (CTIMPs), the sponsor must provide the regulatory authority (MHRA in UK) and the REC that provided the favourable ethics opinion with a safety report once a year until the trial has officially come to an end. This annual safety report is called a Development Safety Update Report (DSUR).
The date the DSUR is due is the anniversary of the first CTA approval, for trials with marketed products the date is the first marketing authorisation granted in the EU.
The Chief Investigator must file the original signed DSUR with related acknowledgements and correspondence in the Trial Master File (TMF)
- Purpose of a DSUR
The purpose of a DSUR is to present a comprehensive, scientific annual review and evaluation of pertinent safety information collected during the reporting period related to a drug under investigation, whether or not it is marketed, by:
- Examining whether the information obtained by the sponsor during the reporting period is in accord with previous knowledge of the product’s safety.
- Describing new safety issues that could have an impact on the protection of clinical study participants.
- Summarising the current understanding and management of identified and potential risks.
- Providing an update on the status of the clinical investigation / development programme and study results.
- Writing a DSUR
The DSUR should be written according to the Noclor DSUR SOP and submitted to MHRA and REC within the regulatory timeframes. The Chief Investigator will be required to sign to acknowledge that they have read and understood the Noclor DSUR SOPs prior to study activation.
The report should be concise and provide information to assure the regulatory authority (MHRA in UK) that the sponsor is adequately monitoring and evaluating the safety profile of the IMP.
Noclor usually outsource pharmacovigilance expertise on CTIMPs (via agreement with a Contract Research Organisation (CRO)). When pharmacovigilance is outsourced the responsibility of preparing and submitting the DSUR will be delegated to the sponsor’s responsible person for pharmacovigilance (they will be the author of the DSUR) with support and co-operation from the Chief Investigator.
The DSUR will need to be notified to REC and participating sites by the Chief Investigator (or pharmacovigilance responsible person as delegated). The DSUR being sent to the REC should be submitted with the REC CTIMP Safety Report coversheet.
- If a DSUR is not required
Where there is no requirement for the sponsor to compile and submit a DSUR for a CTIMP; this should either be documented in the protocol or in a file note signed off by the Chief Investigator and Noclor Sponsor Representative (the file note should be retained in relevant section of the Trial Master File (TMF)) stating why a DSUR is not required (for example, the DSUR will be compiled by the Marketing Authorisation Holder (MAH)).