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Reporting monitoring and recording of Adverse Events for adverse reaction

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Reporting monitoring and recording of Adverse Events for adverse reaction

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									                    CONTROLLED DOCUMENT- DO NOT COPY




                                                                         Research Department




     STANDARD OPERATING PROCEDURE

                           STH Researcher

    Recording, Management and Reporting of
    Adverse Events for externally sponsored
                   studies




SOP History    CSUH 00/017 Adverse Event reporting
SOP Number     A122
Created        STH Research Department (AL)
Reviewed by    STH Research Department (AD)
Superseded     1.3
Version        1.4
Date           02 September 2009
Review Date    September 2010
Related SOPs   A116 Study Site File
               A124 Maintaining the Case Report Form (CRF)
               A123 Recording, management and reporting of AE for STH sponsored studies.
Approved by    Senior Research Manager




                                                                                        A122 SOP Version 1.4
                       Recording, Management and Reporting, of Adverse events for externally sponsored studies
                                                                                           02 September 2009
                                                                                                   Page 1 of 5
                            CONTROLLED DOCUMENT- DO NOT COPY



                           Standard Operating Procedure
    Recording, Management and Reporting of Adverse events for externally sponsored
                                      studies



This SOP has been produced in accordance with the Medicines for Human Use (Clinical Trials)
Regulations 2004, Medicines for Human Use (Clinical Trials) Amendment Regulations 2006 and the
Research Governance Framework 2005. This SOP will outline the procedure for recording,
management and reporting of
     • Adverse Events (AE)
     • Adverse Reactions (AR)
     • Serious Adverse Events (SAE)
     • Suspected Serious Adverse Reactions (SSAR)
     • Suspected Unexpected Serious Adverse Reactions (SUSAR)
for studies that are sponsored by an institution external to STH (Glossary- Appendix 1).

Background

To comply with the Medicines for Human Use (Clinical Trials) Regulations 2004, the sponsor and
Chief investigator must have systems in place for pharmacovigilance.

Definition
This SOP focuses on the recording, management and reporting of all AE, AR, SAE, SSAR and
SUSAR that occur in trial participants and that require reporting in accordance with the Medicines for
Human Use (Clinical Trials) Regulations when sponsorship is accepted by an institution external to
STH. This document outlines the responsibilities of the STH Investigator (Chief or Principal 1 ). Any
delegation of responsibilities to other members of the research team must be agreed in writing
(Delegation of Responsibilities form) and stored in the Site File.
The sponsor provides the STH Principal Investigator (PI) with a 24 hour contact (fax) number (‘Safety
Desk’) for reporting of SAE. The contact number is kept in the STH Investigator Site File.

Procedure for recording events prior to study start.
   1. The sponsor decides how to record events in the Case Report Form (CRF), source document
      (patient notes) and Investigator Site file. The sponsor documents these in the study protocol.
   2. The sponsor decides if any events classed as serious should be excluded from immediate
      reporting for the disease area and documents these in the study protocol.
   3. The STH PI documents delegated responsibilities of event reporting in the site file.

Procedure for reporting Adverse Events and Adverse Reactions.

     1. The STH PI or delegate enquires with the participant at each study visit as to whether there
        have been any adverse events and records all details in full in the Case Report Form (CRF)
        and source document (patient notes).
     2. The STH PI decides the event causality (if this is a reaction to the trial medicine).
     3. The STH PI or delegate follows the procedure outlined in the study protocol for the reporting
        of AE to sponsor.

Procedure for reporting Serious Adverse Events, Serious Suspected Adverse Reactions and
Suspected Unexpected Serious Adverse Reactions.

     1. The STH PI or delegate documents the event in the Case Report Form (CRF) and source
        document.

1
  The investigator who takes primary responsibility for the overall conduct of a trial is the Chief
Investigator. The investigator who takes responsibility for the conduct of a clinical trial at an individual
site is the Principal Investigator. In relation to a clinical trial conducted at a single site the investigator
is may be referred to as both Chief and Principal Investigator.
                                                                                                A122 SOP Version 1.4
                               Recording, Management and Reporting, of Adverse events for externally sponsored studies
                                                                                                   02 September 2009
                                                                                                           Page 2 of 5
                        CONTROLLED DOCUMENT- DO NOT COPY


   2. The STH PI or delegate identifies the event to be serious, using ICH GCP definitions and
       study protocol.
   3. The STH PI or delegated qualified person makes the decision on the event causality.
   4. The STH PI or delegate completes the Serious Adverse Event Reporting Form (or equivalent)
       provided by the Sponsor, providing as much detailed information as known and relevant to
       the event.
   5. The STH PI or delegate faxes the completed, signed SAE report to the sponsors’ study
       ‘Safety Desk’ within 24 hours of discovery of the event.
               5.1 The SAE form is sent to the ‘Safety Desk’ without the STH PI signature if it is not
                    possible to complete before the 24 hour timeframe. The form is re-sent when the
                    signature for the STH PI is added.
   6. The Sponsor identifies the event status (SAE, SSAR or SUSAR).
   7. The Sponsor contacts the STH PI to request additional information if required.
   8. The STH PI provides all requested information to the Sponsor relating to the event.
   9. The STH PI continues to provide information to the Sponsor until the event is resolved.
   10. The STH PI or delegate files all SAE report forms and correspondence relating to the event in
       the Investigator Site File.
   11. Where the event has been classified as a SUSAR
               11.1     The STH PI informs the STH Research Department of the event by fax within
                        24 hours of the event
               11.2     The Research Department makes a decision on the continuation of the study
                        at STH in relation to the reported event based on the risk
               11.3     The Research Department informs the STH PI and Sponsor if the study is to
                        be discontinued at STH


Procedure for receiving reports from the sponsor.

   1. The Sponsor alerts the PIs by fax of any SUSAR event occurrence that may put the safety of
      participants at risk.
   2. The STH PI informs the STH Research Department of the event by fax within 24 hours of
      receiving the alert.
   3. The STH PI files the report in the Investigator Site File.
   4. The Research Department makes a decision on the continuation of the study at STH in
      relation to the reported event based on the risk.
   5. The Research Department informs the STH PI and Sponsor if the study is to be discontinued
      at STH.




                                                                                             A122 SOP Version 1.4
                            Recording, Management and Reporting, of Adverse events for externally sponsored studies
                                                                                                02 September 2009
                                                                                                        Page 3 of 5
                          CONTROLLED DOCUMENT- DO NOT COPY




Appendix 1

Glossary 2

Adverse Event (AE)
Any untoward medical occurrence in a subject to whom a medicinal product has been administered,
including occurrences which are not necessarily caused by or related to that product.

Adverse Reaction (AR)
Any untoward and unintended response in a subject to an investigational medicinal product which is
related to any dose administered to that subject.

Serious Adverse Event/Reaction (SAE/SAR)
Any adverse event or adverse reaction that
    a. results in death
    b. is life threatening 3
    c. requires hospitalisation or prolongation of existing hospitalisation
    d. results in persistent or significant disability or incapacity
    e. consists of a congenital anomaly or birth defect.

Suspected Serious Adverse Reaction (SSAR)
Any adverse reaction that is classed in nature as serious and which is consistent with the information
about the medicinal product in question set out
   a. In the case of a licensed product, the summary of product characteristics (SmPC) for that
        product
   b. In the case of any other investigational medicinal product, the Investigator’s Brochure (IB)
        relating to the trial in question.

Suspected Unexpected Serious Adverse Reaction (SUSAR)
Any adverse reaction that is classed in nature as serious and which is not consistent with the
information about the medicinal product in question set out:
     a. In the case of a licensed product, the summary of product characteristics (SmPC) for that
        product
     b. In the case of any other investigational medicinal product, the Investigator’s Brochure (IB)
        relating to the trial in question.




2
 Glossary taken from Medicines for Human Use (Clinical Trials) Regulations 2004
3
 Life-threatening in the definition of an SAE or SAR refers to an event in which the subject was at risk
of death at the time of the event. It does not refer to an event which hypothetically might have caused
death if it were more severe
                                                                                              A122 SOP Version 1.4
                             Recording, Management and Reporting, of Adverse events for externally sponsored studies
                                                                                                 02 September 2009
                                                                                                         Page 4 of 5
                                 CONTROLLED DOCUMENT- DO NOT COPY


Appendix 2

Associated Documents

           Document                Research Department network location          Website       Database       Created by
1   Delegation of study duties     S:\General\Research Governance\Project       No            No             PC
    log                           Authorisation\Templates\Site file documents




                                                                                                    A122 SOP Version 1.4
                                   Recording, Management and Reporting, of Adverse events for externally sponsored studies
                                                                                                       02 September 2009
                                                                                                               Page 5 of 5

								
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