Docstoc

Identifying recording and reporting adverse events for

Document Sample
Identifying recording and reporting adverse events for Powered By Docstoc
					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




                          Controlled Document – Do Not Copy
                                      Page 1 of 6

                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




                          Controlled Document – Do Not Copy
                                      Page 2 of 6

                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. 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.



                          Controlled Document – Do Not Copy
                                      Page 3 of 6

                 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.

                          Controlled Document – Do Not Copy
                                      Page 4 of 6

                 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




                             Controlled Document – Do Not Copy
                                         Page 5 of 6

                     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.




                           Controlled Document – Do Not Copy
                                       Page 6 of 6

                 This SOP expires on day of printing   07-Oct-2010