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[UCL SOP TEMPLATE Please amend the examples that are highlighted in yellow and delete the guidance notes in [ … ] ]
Standard Operating Procedure for Pharmacovigilance
SOP ID Number: JBRU/SPON/S0X/0X[Each SOP has a “SOP number” and a version number. The QA manager will allocate the “SOP number”, the first version of your SOP should be /01] / Effective Date: 11/12/09
[Should postdate the date of Authorisation outlined in this table, as it needs to provide enough time for SOP training]
Version Number & Date of Authorisation: V03, 25/11/09 [should predate the Effective date, to leave time for SOP training if necessary] / Review Date: 11/12/11
[Should be 2 years from the effective date above]
eDocument kept: EXAMPLE: S:\CLINICAL_TRIALS\SOPs\EFFECTIVE_SOPs_Guides\SPONSOR SOPs\SPON_S01,UCL SOP template V3, 261209.doc
Revision Chronology:
SOP ID Number: / Effective Date: / Reason for Change: / Author:
JBRU/SPON/S01/03 / 11/12/09 / EXAMPLE: “increased the review date time line from one year to two years or before if necessary.” / Marguerite Duras
ACRONYMS:
JBRU / Joint Biomedical Research Unit http://www.ucl.ac.uk/joint-rd-unit
GCP / Good Clinical Practice
SOP / Standard Operating Procedure
CI / Chief Investigator
PI / Principal Investigator
TMF / Trial Master File
ISF / Investigator Site File
MHRA / Medicines and Healthcare Products Regulatory Agency
MREC / Main Research Ethics Committee
QA / Quality Assurance
[Please carry out the following:
View/Header and footer/Insert AutoText/File name and path
View/Header and footer/Insert AutoText/Page X of Y]
Standard Operating Procedure for Pharmacovigilance [Replace what is in yellow by your SOP title]
1. PURPOSE
This Standard Operating Procedure (SOP) has been written to describe the procedure for Pharmacovigilance.
2. JOINT UCLH/UCL BIOMEDICAL RESEARCH UNIT POLICY
All SOPs produced from the JBRU must be used in conjunction with local NHS Trust and UCL policies and procedures.
The JBRU acts as the representative of the Sponsor and will be the official name used on all SOPs.
3. BACKGROUND
All SOPs are written in accordance with applicable GCP requirements as outlined in Directives 2001/20/EC and2005/20/EC (in the UK, these Directives were transposed into UK law by SI 2004/1031, SI 2006/1928) and subsequent amendments and where applicable incorporates elements of ICH GCP tripartite guidelines (E6)"
[EXAMPLE: As part of implementing Good Clinical Practice (GCP) the Sponsor needs to implement systems with procedures that assure the quality of every aspect of the trial.]
[EXAMPLE 3.1 Definition of SOP:]
[SOPs are detailed written instructions to achieve uniformity of the performance of specific functions and set out the way practice and procedures must (i.e. mandatory) or should (i.e. advisory) be performed. ]
[EXAMPLE 3.2 Sponsor SOPs:
These SOPs will focus on internal processes and procedures.]
4. SCOPE OF THIS SOP
[EXAMPLE This SOP relates to the preparation, review, approval, and revision of SOPs that are produced from JBRU for either trials solely sponsored by UCL or UCLH/UCL jointly sponsored trials.]
5. RESPONSIBLE PERSONNEL
[EXAMPLE: The Head of Quality Assurance (QA) will be responsible for the following, in relation to SOP production and management.]
6. PROCEDURE
6.1 Please ensure you that are using the most recent UCL SOP Template by looking up http://www.ucl.ac.uk/joint-rd-unit
6.2 Issuing a SOP ID number
The Head of QA Will:
· issue the next sequential SOP ID number to be used,
7. REFERENCES [Do not forget to ref the websites]
http://www.ucl.ac.uk/joint-rd-unit
ICH Harmonised Tripartite Guideline for Good Clinical Practice (1996)
“COMMISSION DIRECTIVE 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products”.
8. APPENDICES
9. TEMPLATES/LOGS ASSOCITATED TO THIS SOP [If available, provide the weblinks from where the most recent templates can be obtained]
EXAMPLE:
1 / UCL SOP TEMPLATE, http://www.ucl.ac.uk/joint-rd-unit2 / SOP training log (Section 12 of each SOP), http://www.ucl.ac.uk/joint-rd-unit
3 / Individual Staff SOP and courses log, http://www.ucl.ac.uk/joint-rd-unit
10. SOP DISSEMINATION AND TRAINING
SOPs will be distributed to the concerned staff, by the named author on the front page of the SOP. Staff concerned by the SOP will sign the SOP training log (12. SOP TRAINING LOG) which is part of each SOP. In addition, each staff should have an “Individual Staff SOP and courses log” (template available in the http://www.ucl.ac.uk/joint-rd-unit website) and will need to update it once trained on the SOP.
In some instances, the SOP or the changes to the SOP will be basic. The training will constitute of the person reading the SOP and being provided with the opportunity to ask specific questions to the author of the SOP. In some instances, the staff member being trained will carry out the procedure under supervision of the author of the SOP or under supervision of a staff member who has been trained and is using the SOP. Both trainee and trainer (should the SOP require training) will need to sign and date the “SOP training log” in section 12 of each SOP and the “Individual staff SOP and courses log”.
SOPs relevant to “JBRU staff and investigators” or investigators only will be provided to the investigators at the time of the trial initiation. The investigator will sign section 12 of the SOP, the “SOP training log”.
New SOPs relevant to “JBRU staff and investigators” or investigators only will be emailed to the investigators by the author of the SOP. The investigators will be requested to read the new SOP and email back to acknowledge receipt and understanding of the new SOP. The email sent to the investigators and their emails acknowledging receipt and understanding of the SOP should be printed out and filed in the JBRU SOP folder together with the relevant SOP.
The SOPs and relevant templates and logs will be available on the JBRU website shortly after having been released.
If relevant, the Cancer Trial Centre and other Departments should be emailed the new SOPs or the website link to the SOP.
11. SIGNATURE PAGE
Author and Job Title:Signature:
Date:
Authorised by:
Name and Job Title
Signature:
Date:
[Do not forget to put the title of your SOP in the footer EXAMPLE: “SOP on Pharmacovigilance”, and also the SOP number and the version number ]
SOP on Pharmacovigilance
JBRU/SPON/S01/03
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12. SOP TRAINING LOG
/ Name of Staff (Capital letters) / Job Title:Department: / Training Date / I confirm that I understand & agree to work to this SOP
SIGNATURE / Name of Trainer (if training required) / Signature / Date /
1
2
3
4
5
6
7
8
9
10
11
12
13
SOP on Pharmacovigilance
JBRU/SPON/S01/03
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