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ACCORD/ECTU SOP Number: ACCORD/ECTU/SOP12/2.0
NHS Lothian R&D and Version: 2.0
The University of Edinburgh Effective Date: 27/10/2008
STANDARD OPERATING PROCEDURE FOR IDENTIFYING,
RECORDING AND REPORTING ADVERSE EVENTS FOR
RESEARCH OTHER THAN CLINICAL TRIALS OF
INVESTIGATIONAL MEDICINAL PRODUCTS
SOP NUMBER: ACCORD/ECTU/SOP12/2.0
VERSION NUMBER: 2.0
PREVIOUS VERSIONS: 1.0
EFFECTIVE DATE: 27/10/2008
REVIEW DATE: 26/10/2010
AUTHOR: Fiona Sloan (Clinical Trials Monitor)
APPROVED BY (1): .....Tina.McLelland...................................
(R&D Governance Manager, NHS Lothian)
DATE APPROVED: 24/10/2008
APPROVED BY (2): ..... Anne.Langston................................
(Associate Director, ECTU, University of Edinburgh)
DATE APPROVED: 23/10/2008
RELEASED BY: .....Alex.MacLellan........................................
(QA Manager, ECMC, University of Edinburgh)
DATE RELEASED: 24/10/2008
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This SOP expires on day of printing 07-Oct-2010
ACCORD/ECTU SOP Number: ACCORD/ECTU/SOP12/2.0
NHS Lothian R&D and Version: 2.0
The University of Edinburgh Effective Date: 27/10/2008
DOCUMENT HISTORY
Version Edited by (job title): Effective Details of editions made:
Number: Date:
2.0 01/10/2008
1.0 10/05/2007 New
1. PURPOSE
To describe the procedure for identifying, recording and reporting adverse events
occurring in research other than clinical trials of investigational medicinal products
(non-CTIMPs) that are sponsored by NHS Lothian and/or the University of
Edinburgh.
2. APPLICABILITY
Applies to all non-CTIMPs sponsored by NHS Lothian and/or the University of
Edinburgh.
Applies to all researchers (including external researchers for multi-centre trials)
running or participating in non-CTIMPs sponsored by NHS Lothian and/or the
University of Edinburgh.
3. POLICY
Adverse event reporting in non-CTIMPs will be carried out in accordance with the
principles of GCP and follows the guidance given by the National Research Ethics
Service (NRES) for safety reporting in non-CTIMPs.
4. DEFINITIONS
4.1 Adverse Event (AE)
Any untoward medical occurrence in a patient or research study subject.
4.2 Serious Adverse Event (SAE)
Any untoward medical occurrence or effect that;
• results in death
• is life-threatening
• requires hospitalisation or prolongation of existing hospitalisation
• results in persistent or significant disability or incapacity
• consists of a congenital anomaly or birth defect
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ACCORD/ECTU SOP Number: ACCORD/ECTU/SOP12/2.0
NHS Lothian R&D and Version: 2.0
The University of Edinburgh Effective Date: 27/10/2008
5. PROCEDURE
5.1 IDENTIFIYING ADVERSE EVENTS
5.1.1 The protocol should define what adverse events are to be recorded and
reported. The decision on what adverse event data to record should be the
result of an assessment of the risk associated with the research.
5.1.2 The protocol should define and justify what SAEs will not be subject to
expedited reporting to the Sponsor.
5.1.3 The protocol should also define how adverse events will be identified. For
the majority of studies, the Investigator(s) (or a member of the research team
with delegated responsibility to do so) should ask patients about
hospitalisations, consultations with other medical practitioners, disability or
incapacity or whether any other adverse events have occurred.
5.1.4 Adverse events may also be identified by support departments, for example,
clinical biochemistry, haematology, radiology. Where notification of such
abnormal values or measurements would not occur as standard clinical
practice, the procedure for notifying the Investigator of such adverse events
must be clearly documented in the protocol or research specific SOPs.
5.2 RECORDING AEs AND SAEs
5.2.1 The protocol should define exactly what adverse event data points should be
recorded and the case report forms (CRFs) and/or AE and SAE forms should
be designed accordingly.
5.2.2 AE and SAE data should be recorded by the Investigator(s) (or a member of
the research team with delegated responsibility to do so) on CRFs and/or AE
and SAE forms.
5.2.3 Unless otherwise stated in the protocol AEs and SAEs should be followed up
until resolution or death of the patient.
5.3 ASSESSMENT OF ADVERSE EVENTS
5.3.1 Each AE must be assessed by the investigator for seriousness using the
criteria defined in section 4.2.
5.3.2 If AEs are considered to be serious (SAEs), the Investigator must then
consider if the event was;
‘related’ - that is, it resulted from administration of research procedures and
‘unexpected’ – that is, the type of event is not listed in the protocol as an
expected occurrence.
5.3.3 It is the Investigator(s) responsibility to assess each AE and this may not be
delegated to other members of the research team.
5.4 REPORTING SAEs
5.4.1 SAEs should be reported to the ACCORD Office, as representative of the
Sponsor, within 24 hours of becoming aware of the event unless otherwise
stated in the study protocol.
5.4.2 SAEs should be reported using an NRES Report of Serious Adverse Event
Form (attachment 1) and should be faxed to 0131 242 9447.
5.4.3 SAE reports should be as complete as possible and should be signed and
dated by the Investigator.
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This SOP expires on day of printing 07-Oct-2010
ACCORD/ECTU SOP Number: ACCORD/ECTU/SOP12/2.0
NHS Lothian R&D and Version: 2.0
The University of Edinburgh Effective Date: 27/10/2008
5.4.4 The ACCORD Office is responsible for reporting SAEs that are considered to
be ‘related’ and ‘unexpected’ as described in section 5.3.2 to the research
ethics committee (REC) that approved the study (main REC) within 15 days
of the ACCORD Office becoming aware of the event.
5.4.5 Related, unexpected SAEs will be reported to the main REC using the NRES
Report of Serious Adverse Event Form.
5.4.6 The coordinator of the main REC should acknowledge receipt of related,
unexpected safety reports within 30 days.
5.4.7 Related, unexpected SAEs from double-blinded studies should be unblinded
before reporting to the main REC.
5.4.8 SAEs should be reported to the Data Monitoring Committee (DMC) and/or the
Trial Management Group (TMG) and/or the Trial Steering Committee (TSC)
as appropriate.
5.4.9 In multi-centre research studies, it is the responsibility of the Chief
Investigator (CI) to inform the Principal Investigators (PI) at each site of all
SAEs reported.
5.4.10 All copies of SAE forms sent to the ACCORD Office and any subsequent
correspondence should be kept by the Investigator in the Investigator Site File
(ISF).
5.4.11 All copies of SAE forms received by the ACCORD Office and any subsequent
correspondence to and from the main REC should be kept by the Sponsor in
the NHS R&D file.
6. ATTACHMENTS
1. NRES Report of Serious Adverse Event Form
7. DEFINITIONS
ACCORD Academic and Clinical Central Office for Research and Development).
The ACCORD office is a collaboration between NHS Lothian and The
University of Edinburgh to form a joint research and development
office to facilitate clinical research.
ECTU Edinburgh Clinical Trials Unit
8. REFERENCES
NRES guidance “Safety reports for research other than clinical trials of investigational
medicinal products (CTIMPs)”
(http://www.nres.npsa.nhs.uk/applicants/review/after/safety)
The Medicines for Human Use (Clinical Trials) Regulations 2004, (SI 2004 No. 1031).
The Medicines for Human Use (Clinical Trials) Amendment Regulations 2006, (SI
2006 No. 1928).
Good Clinical Laboratory Practice (GCLP), BARQA 2003.
Declaration of Helsinki, Clarification of 5th Revision, 2004.
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This SOP expires on day of printing 07-Oct-2010
ACCORD/ECTU SOP Number: ACCORD/ECTU/SOP12/2.0
NHS Lothian R&D and Version: 2.0
The University of Edinburgh Effective Date: 27/10/2008
ATTACHMENT 1
REPORT OF SERIOUS ADVERSE EVENT (SAE)
(For all studies except clinical trials of investigational medicinal products)
The Chief Investigator should report any SAE that is both related to the
research procedures and is unexpected. Send the report to the Research
Ethics Committee that gave a favourable opinion of the research within 15 days
of the CI becoming aware of the event. For further guidance see:
http://www.nres.npsa.nhs.uk/applicants/review/after/safety.htm.
1. Details of Chief Investigator
Name:
Address:
Telephone:
Email:
Fax:
2. Details of study
Full title of study:
Name of main REC:
Main REC reference number:
Research sponsor:
Sponsor’s reference for this report:
(if applicable)
3. Type of event
Please categorise this event, ticking all appropriate options:
Death Life threatening Hospitalisation or
prolongation of existing
hospitalization
Persistent or significant Congenital anomaly Other
disability or incapacity or birth defect
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This SOP expires on day of printing 07-Oct-2010
ACCORD/ECTU SOP Number: ACCORD/ECTU/SOP12/2.0
NHS Lothian R&D and Version: 2.0
The University of Edinburgh Effective Date: 27/10/2008
4. Circumstances of event
Date of SAE:
Location:
Describe the circumstances of
the event:
(Attach copy of detailed report
if necessary)
What is your assessment of the
implications, if any, for the
safety of study participants and
how will these be addressed?
5. Declaration
Signature of Chief Investigator:
Print name:
Date of submission:
6. Acknowledgement of receipt by main REC (please insert name):
The [ ] Research Ethics Committee acknowledges receipt of the above.
Signed:
Name:
Position on REC:
Date:
Signed original to be sent back to Chief Investigator (or other person submitting
report)
Copy to be kept for information by main REC.
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