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
PREPARING AND SUBMITTING PROGRESS AND SAFETY
REPORTS
SOP NUMBER:
CR008
VERSION NUMBER: 2.0
EFFECTIVE DATE:
RELEASE DATE:
14/September/2011
31/August/2011
Signature
AUTHOR: Gareth Thomas, Clinical Trials Monitor, ACCORD
Date
30th August
2011
APPROVED BY (1): Marise Buçukoğlu University of Edinburgh, Head
of Research Governance
APPROVED BY (2): Dawn Lyster, QA Officer, ACCORD
31st August
2011
31st August
2011
REVIEWED BY: Louisa Wilson, Lynn Morrice, Paul Dearie,
Parties using this SOP must visit www.accord.ed.ac.uk to guarantee adherence to the
latest version
Page 1 of 5

ACCORD
NHS Lothian R&D and
The University of Edinburgh
SOP Number: CR008v2.0
Effective Date: 14/SEP/2011
1. INTRODUCTION
It is a requirement of maintaining both Research Ethics Committee approval and a
Clinical Trials Authorisation (CTA) that reports are submitted at least annually. It is
imperative that the Sponsor of a study is able to maintain oversight of these reports
especially where their submission is the Sponsor’s responsibility.
2. PURPOSE
To document the procedure for preparing and submitting annual progress reports
and annual safety reports. It also outlines in what instances they are applicable and
who is responsible for their completion and dissemination to relevant parties.
3. SCOPE
This Standard Operating Procedure (SOP) applies to Chief Investigators (CIs), or
designees, for all studies sponsored by NHS Lothian and/or the University of
Edinburgh (UoE). CIs must ensure that annual progress reports are submitted. In
addition, for studies that require a CTA, there is an additional obligation for the CI to
prepare annual safety reports in the form of a Development Safety Update Report
(DSUR). The SOP also applies to the ACCORD Governance and QA team. In order
to ensure sponsor oversight, the ACCORD Governance and QA team are
responsible for administering and logging this process; reviewing the content of the
reports; submitting annual safety reports; and filing the paperwork.
4. REFERENCES
EMEA, “Note for Guidance on Good Clinical Practice” (E6) R1, CPMP/ICH/135/95.
The Medicines for Human Use (clinical trials) Regulations 2004.
http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingofmedicines/Clinicaltrial
s/Safetyreporting-SUSARsandASRs/index.htm
accessed 17/11/10, 1130hrs.
http://www.nres.npsa.nhs.uk/applications/after-ethical-review/annual-progressreports/
accessed 17/11/10, 1100hrs.
http://www.nres.npsa.nhs.uk/applications/after-ethical-review/annual-progressreports/#progressSafety
accessed 17/11/10 1200hrs.
http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingofmedicines/Clinicaltrial
s/ManagingyourCTA/Endoftrial/index.htm
accessed 17/11/10, 1200hrs.
Parties using this SOP must visit www.accord.ed.ac.uk to guarantee adherence to the
latest version
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ACCORD
NHS Lothian R&D and
The University of Edinburgh
SOP Number: CR008v2.0
Effective Date: 14/SEP/2011
5. PROCEDURE
5.1 Responsibilities
5.1.1 It is the responsibility of the Chief Investigator (CI) to ensure annual progress
reports are completed and submitted to relevant parties.
5.1.2 For studies that require a CTA, it is also the responsibility of the CI to
complete annual safety reports. The sponsor is responsible for submitting annual
safety reports to the relevant parties
5.1.3 For studies that require a CTA, the Senior Clinical Trials Monitor or Quality
Assurance (QA) Officer, or designee, will be responsible for ensuring that the Chief
Investigator for each study is contacted and provided with a partially completed
annual progress or annual safety report 6-10 weeks prior to the deadline for the
report.
5.1.4 Prior to submission to the regulatory authority the annual safety report must
be reviewed by the Senior Clinical Trials Monitor, or designee, or QA Officer.
5.2 Annual Progress Reports (All Studies)
5.2.1 Annual progress reports for all research studies must be submitted to the
Research Ethics Committee REC that approved the study and the sponsor.
5.2.2 Annual progress reports must be submitted on the anniversary of receipt of a
favourable ethical opinion from the main REC and then every year until completion of
the study.
5.2.3 An annual progress report must be submitted for all studies, even if they have
not started before the first anniversary of approval. The report should clearly explain
the reasons why the study has not started.
5.2.4 For Clinical Trials of Investigational Medicinal products (CTIMPs) annual
progress reports will be submitted to the REC using an NRES annual progress report
form. This can be found on the NRES website
http://www.nres.npsa.nhs.uk/applications/after-ethical-review/annual-progressreports/
5.2.5 Where the responsibility for preparing the annual reports has been delegated
to another party by the CI, the CI must review and sign the report before submission
to the main REC.
5.2.6 The annual progress report will be acknowledged by the REC coordinator
within 30 days. The REC may write to the CI for further information if they identify
any issues with the report.
5.2.7 The CI must ensure that a copy of the annual progress report,
acknowledgement from the REC, and any other relevant progress reports are sent to
the sponsor for inclusion in the Trial Master File (TMF).
5.3 Annual Safety Reports (CTIMPs)
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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.
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latest version
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ACCORD
NHS Lothian R&D and
The University of Edinburgh
SOP Number: CR008v2.0
Effective Date: 14/SEP/2011
5.3.9 The report will be forwarded on to the relevant parties by the Senior Clinical
Trials Monitor, or designee, or QA Officer. The CI will then be notified that the report
has been sent.
5.3.10 The DSUR will be acknowledged by the REC coordinator within 30 days by
signing and returning a copy of the covering form. Reports sent without the covering
form will not be acknowledged.
5.3.11 The Senior Clinical Trials Monitor, or designee, or QA Officer will ensure that a
copy of the annual safety report and acknowledgement from the main REC is filed in
the TMF. If this is sent directly to the CI the CI must ensure this is forwarded to the
Senior Clinical Trials Monitor, or designee, or QA Officer
6. RELATED DOCUMENTS
CR009 Study Closure and Archiving
7. DOCUMENT HISTORY
Version Effective Reason(s) for change(s):
Number: Date:
1.0 22/Mar/2011 DSUR requirements
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latest version
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