Template Standard Operating Procedure for Pharmacovigilance

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					                                                                                    CU/08/T04/3.0



                            Template Trial Specific SOP for
                            Adverse Event (AE) reporting.

Instructions for use
This template is designed to be used in conjunction with the Standard Operating Procedure
for the Managing and Reporting Research related Adverse Events in Clinical Trials of an
Investigational Medicinal Product (IMP) (CU/07/S06). The Chief Investigator (CI) should
ensure that an adequate Pharmacovigilance reporting system is described in the trial
protocol and/or trial SOPs. Where the Pharmacovigilance system is not adequately described
in the Protocol or Trial SOP, the CI should use this Cardiff University template for creating a
trial Pharmacovigilance SOP.

 Sponsor number:
 Trial Title



 Chief Investigator



 SOP Number:                                                      Effective Date:

 Version Number and Date:                                         Review Date:

 Superseded Version Number and Date:



 Author:
                                        Position:
                                                    ______________________            _________

 Approved by:


 Name:                                  Position:
                                                    ______________________            _________
                                                             Signature                   Date




Definitions

An Adverse Event (AE) is any untoward medical occurrence in a participant to whom an
investigational medicinal product (IMP) has been administered, including occurrences which
are not necessarily caused by or related to that product.

An Adverse Reaction (AR) is any untoward and unintended response, in a participant, to an
IMP which is related to any dose administered to that participant. An Adverse Reaction is
an Adverse Event with a causal relationship to the IMP.
                                                                                       Page 1 of 5

                   Pharmacovigilance SOP for [INSERT TRIAL IDENTIFIER]
                               [INSERT VERSION NUMBER]
                                                                                 CU/08/T04/3.0


Serious Adverse Event (SAE), Serious Adverse Reaction (SAR) or Serious unexpected
Adverse Reaction (SUSAR) is defined as an Adverse Event, Adverse Reaction or unexpected
Adverse Reaction that:

                 results in death;
                 is life-threatening1;
                 requires hospitalisation or prolongation of existing hospitalisation2;
                 results in persistent or significant disability or incapacity;
                 consists of a congenital anomaly or birth defect; or
                 is medically significant3;
                 [INSERT TRIAL SPECIFIC PARAMETERS TO BE DEFINED AS AN SAE].
1
 The term “life-threatening” in the definition of serious refers to an event in which the
participant 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.
2
 Hospitalisation is defined as an inpatient admission, regardless of the length of stay, even if
the hospitalisation is a precautionary measure, for continued observation. Pre-planned
hospitalisation e.g. for pre-existing conditions which have not worsened or elective
procedures does not constitute an adverse event.
3
  Other events that may not result in death are not life-threatening, or do not require
hospitalisation may be considered as a serious adverse event when, based upon appropriate
medical judgement, the event may jeopardise the participant and may require medical or
surgical intervention to prevent one of the outcomes listed above.

Pregnancy in either a participant or the partner of a participant taking trial medication
should be reported as a SAE.

A Suspected Unexpected Serious Adverse Reaction (SUSAR) is an adverse reaction that is
both serious and unexpected (i.e. the nature and severity of which is not consistent with the
information about the IMP in question set out in the Summary of Product Characteristics
(SmPC) for that product and/or in the Investigator's Brochure or study protocol).



1. Expected Adverse Reactions
Expected Adverse Reactions to the trial treatment(s) are detailed below:

       INSERT DETAILS



The above list should not be relied upon. Always refer to the current Investigator’s
Brochure/Summary of Product Characteristics when assessing the expectedness of an
Adverse Reaction.




                                                                                     Page 2 of 5

                   Pharmacovigilance SOP for [INSERT TRIAL IDENTIFIER]
                               [INSERT VERSION NUMBER]
                                                                                   CU/08/T04/3.0


2. Participating Centre Responsibilities
[INSERT INSTRUCTIONS on which types of AEs Principal Investigators (PIs) will be required to
report during the trial and how the AEs should be recorded, eg on the Trial Case Report Form
(CRF) or Adverse Event Form]

AEs will be collected from [e.g. the time the participant signs the trial consent form] until
[e.g. one month after the last trial visit].

2.1 Assessing AEs

The PI should assess the AE for [DELETE AS APPROPRIATE]: seriousness, causality and
expectedness.

Seriousness
An AE should be assessed as serious if it meets one or more of the following criteria:

           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;
           Is medically significant; or
           Requires intervention to prevent any one of the above outcomes.
           [INSERT TRIAL SPECIFIC PARAMETERS TO BE DEFINED AS AN SAE - These must
                        concur with what is written in the protocol & SAE form].

The PI should exercise medical judgement in deciding whether an Adverse Event/Reaction is
serious in other situations.

All SAEs should be reported to the [INSERT DETAILS] by the PI immediately (24hrs) of them
becoming aware of the event. SAEs which are expected consequences of the treatment are
defined as follows and therefore do not need immediate reporting:

       [INSERT DETAILS]
    
    

The SAEs which do not require immediate reporting should be recorded and reported
[INSERT DETAILS OF RECORDING AND REPORTING REQUIREMENTS e.g. as per non-serious
AE/AR procedure].

Causality

[INSERT DETAILS of responsibilities for assessing Causality and methods for making that
assessment].

Expectedness

[INSERT DETAILS of expected AEs and responsibilities for assessing Expectedness and
methods for making that assessment]. The expectedness of an adverse reaction shall be
determined according to the reference documents as defined in the study protocol (e.g.
                                                                                      Page 3 of 5

                    Pharmacovigilance SOP for [INSERT TRIAL IDENTIFIER]
                                [INSERT VERSION NUMBER]
                                                                                 CU/08/T04/3.0


Investigator Brochure or marketing information). It is therefore important to identify all
potential adverse reactions in the study protocol.

2.2 Reporting procedures

[INSERT DETAILS on how AEs should be reported and to whom they should be reported.]

All [INSERT details on AEs to be reported] must be reported immediately by the PI to [INSERT
DETAILS –usually the Chief Investigator (CI) or Trials Unit] unless specified as not requiring
immediate reporting (refer to section xxx)

                          Serious Adverse Event (SAE) Fax Number:

                                    [Enter Telephone No.]


Initial reports should be submitted as soon as the following minimum criteria are met:
              A suspected IMP is identified;
              An identifiable participant (e.g. trial participant code number);
              An AE assessed as serious and unexpected, and for which there is a
                  reasonable suspected causal relationship.
              An identifiable reporting source (e.g. a PI)

Following the Initial Report, all SAEs should be followed to resolution. The participant
should only be identified by trial number, date of birth and initials. The participant’s name
should not be used on any correspondence.

PIs are responsible for reporting AEs to their NHS Trust as per their local NHS Trust
procedures.

3. Chief Investigator Responsibilities
Following the initial report the PI may be requested to provide further information.

Once an SAE is received by the CI, it will be evaluated by the CI (or his/her delegate) for
seriousness, expectedness and causality.

The [INSERT DETAILS] will notify the MHRA and main REC of all SUSARs according to the
following timelines: Fatal and life threatening SUSARs not later than 7 days after notification
that the case fulfilled the minimum criteria for initial expedited reporting; Non fatal or non
life-threatening SUSARs not later than 15 days after notification that the case fulfilled the
minimum criteria for initial expedited reporting. Follow up information should be reported
within 8 days of receipt of the follow up information.

In addition to reporting to the relevant REC and the MHRA, the CI shall notify the following
bodies within [INSERT TIMEFRAME] of all [INSERT AEs to be notifieid, e.g. SAEs]:

               Other bodies specified in the protocol (e.g. a Trial Steering Committee);
               Other bodies specified in contractual agreements (e.g. a Pharmaceutical
                company supplying the Trial drug).



                                                                                    Page 4 of 5

                   Pharmacovigilance SOP for [INSERT TRIAL IDENTIFIER]
                               [INSERT VERSION NUMBER]
                                                                                 CU/08/T04/3.0


The CI shall ensure that all PIs receive regular safety updates of SUSARs that occur in relation
to any IMP in that trial. [FREQUENCY OF REPORTS TO BE DETERMINED BY THE TRIAL RISK
ASSESSMENT].

3.1 Safety Report/ Line Listing
One year following the granting of a CTA, and thereafter annually, the CI should compile an
annual safety report [refer to Template T08 – annual safety reports].

3.2 Urgent Safety measures

Urgent safety measures which are implemented immediately by the PI should be notified to
[INSERT DETAILS] immediately, along with the reasons for the measure being taken.

The CI shall be responsible for reporting urgent safety measures to MHRA and REC. This
should include an initial contact with a medical assessor at the MHRA to discuss the urgent
safety measure, followed by a detailed written report within 3 days. The report should
include details of the urgent safety notification, the measures taken and the reason for the
measures and details of any discussion with the MHRA medical assessor.

4. Summary of Adverse Event recording and reporting procedures
It is useful to include a diagram summarising the above procedures.




                                                                                     Page 5 of 5

                   Pharmacovigilance SOP for [INSERT TRIAL IDENTIFIER]
                               [INSERT VERSION NUMBER]

				
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