STANDARD OPERATING PROCEDURE FOR THE ... - Accord

ACCORD
NHS Lothian R&D and
The University of Edinburgh
SOP Number: CR008v2.0
Effective Date: 14/SEP/2011
5.3.1 For all studies that require a CTA annual safety reports must be submitted to
the competent authority, the REC that approved the study and the sponsor. The
annual safety report will be prepared in the Development Safety Update Report
(DSUR) format.
5.3.2 The DSUR is due on the anniversary of Clinical Trial Authorisation (CTA)
being granted by the competent authority or the Development International Birth Date
(DIBD) – see 5.3.5. The DIBD falls on the date of the first authorisation to conduct a
clinical trial of the Investigation Medicinal Product (IMP) in question. Reports must be
submitted every year until completion of the trial.
5.3.3 For studies that require a CTA lasting less than a year, a DSUR must be
submitted with a Declaration of the End of Trial Notification Form within 90 days of
the trial ending or within 15 days if the trial is stopped early.
5.3.4 A DSUR must be submitted for all clinical trials, even if they have not started
before the first anniversary of approval. The report should clearly explain the
reasons why the trial has not started.
5.3.5 CIs conducting more than one trial with the same Investigational Medicinal
Product (IMP) may submit one DSUR for all these trials. Such combined annual
safety reports will be due on the DIBD. If it is not possible to ascertain the DIBD, the
date of the CTA for the first study implicated can be used instead.
5.3.6 The report will be prepared by the CI. Guidance on how to complete the
DSUR can be found here:
http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/0
9/WC500097061.pdf
An example for a complete DSUR can be found here:
http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E2F
/Examples_DSUR/E2F_Example_non-commercial_DSUR.pdf
The draft DSUR will be forwarded to the Senior Clinical Trials Monitor or QA Officer,
or designee, (contact details at www.accord.ed.ac.uk) for review. The Senior Clinical
Trials Monitor, or designee, or QA Officer will ensure the DSUR is reviewed to ensure
reconciliation (including appropriate line listings) with the ACCORD safety database.
The ACCORD office can also provide guidance on the completion of this report upon
request. The CI must review and sign the report.
5.3.7 When sending the DSUR to the REC, there is an additional form supplied by
NRES that must accompany the report. This is found here:
http://www.nres.npsa.nhs.uk/applications/after-ethical-review/safetyreports/safetyreports-for-ctimps/submitting-safety-reports-to-the-rec/
This will be completed by the chief investigator or designee.
5.3.8 The CI, or designee, will forward the completed DSUR and NRES covering
form to the Senior Clinical Trials Monitor, or designee, or QA Officer.
Parties using this SOP must visit www.accord.ed.ac.uk to guarantee adherence to the
latest version
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