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Standard Operating Procedure for the Preparation, Review and Approval of Standard Operating Procedures for UCL Sponsored Clinical Trials
SOP ID Number:JRO/SPON/S01/04 / Effective Date: 11/01/2012Version Number & Date of Authorisation:V04, 11/01/2012 / Review Date: 11/01/2014
SOP eDocument kept:S:\CLINICAL_TRIALS\SOPs\EFFECTIVE_SOPs_Guides\SPONSOR SOPs\SPON_S01 SOPs on SOPs\SPON_S01_ SOP on SOPs_V04.doc
Revision Chronology:
SOP ID Number: / Effective Date: / Reason for Change: / Author:
CRN/04/S01/00 / 25/11/04 / N/A / Yvanne Enever
BRD/04/S01/01 / 20/04/05 / Administrative changes updating CRN to Biomedicine R&D Unit. / Yvanne Enever
BRD/04/S01/01 / 30/09/05 / Administrative changes i.e. new corporate header. Changes in job title. Clearer definition of version control P2. / Yvanne Enever
JRO/07/INT/S01/00 / 18/06/07 / Newly created Joint SOP for UCL/UCLH joint unit. New numbering system adopted for joint SOPs so SOP became an original version. / Yvanne Enever
JRO/INT/S01/01 / 11/07/08 / Updated content and standardised format providing template SOP. Removed date in SOP ID. / Yvanne Enever
JRO/SPON/S01/02 / 06/10/08 / Removed ‘superseded version number and date’ from table in on front page as information is in the Revision Chronology Table. Replaced INT in the SOP ID with SPON, added author definition, defined the different type of dates more clearly, clarified the procedure section. / Joanna Galea-Lauri
JRO/SPON/S01/03 / 10/01/10 / Document was due for review, increased the review time line from “one year” to “two years or before if necessary”, added a SOP training log, and a “List of template & Logs associated with the SOP” table. Added an “Acronyms table”. Added on the front page a row “SOP eDocument kept: “, to facilitate the location of the electronic version of the SOPs. Added in the header “file name and path” to facilitate the identification of the electronic document. A UCL only logo as moving forward, UCLH will no longer sponsor CTIMPs. / Helen Cadiou
JRO/SPON/S01/04 / 11/01/12 / Few changes, the due date for review was up. The Department’s name was changed from JBRU to JRO. The “Individual staff SOP and courses log” is no longer used. / Helen cadiou
ACRONYMS:
JRO / Joint Research Office (RF/UCLH/UCL)
GCP / Good Clinical Practice
SOP / Standard Operating Procedure
CI / Chief Investigator
PI / Principal Investigator
MHRA / Medicines and Healthcare Products Regulatory Agency
REC / Research Ethics Committee
QA / Quality Assurance
Standard Operating Procedure for the Preparation,
Review and Approval of Standard Operating Procedures
for UCL Sponsored Trials
1. PURPOSE
This Standard Operating Procedure (SOP) has been written to describe the procedure for the preparation, approval, review and revision of SOPs for the Joint RF/UCLH/UCL Research Unit (JRO) for trials sponsored by University College London (UCL).Please look up the“UCL SOPTEMPLATE”on the JRO website: prior to reading this SOP.
2. JOINT RF/UCLH/UCL RESEARCH UNIT (JRO) POLICY
All SOPs produced from the JRO must be used in conjunction with local NHS Trust and UCL policies and procedures. SOPs should be written by individuals (authors) deemed competent and experienced to do so and written in accordance with this SOP using the SOP template. The author should be involved in the activity described in the SOP. This will ensure that the SOP actually reflects the practicalities of carrying out the task.
The JRO acts as the representative of the Sponsor and will be the official name used on all SOPs.
3. BACKGROUND
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. This is achieved in part by means of SOPs, which need to be written to an agreed format.
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)"
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. SOPs are written instructions and records of procedures agreed and adopted by individual study teams. They must clearly define ’who does what’ referring to personnel by their job title rather than their name. SOPs should be clear, concise, of common style, format and content, available where and when needed. They should be subject to a system of document control and fit for use. A SOP should be written as soon as the need for a standard written procedure for an activity is identified.
As and when necessary, the JRO will be responsible for producing two “suites” of SOPs: one suite called Sponsor SOPs (for Sponsor only or for Sponsor and Investigators) and another called Investigator SOPs (specifically written for investigators).
3.2 Sponsor SOPs:
These SOPs will focus on:
3.2.1 internal processes and procedures that must be followedby members of staff at the JROin relation to clinical trial management or
3.2.1 processes which are relevant to both the JRO and investigators
and will be referred to throughout this document as ‘Sponsor’ SOPs.
Sponsor SOPs will be issued with a unique SOP number e.g. (SPON/S01/01). This number identifies firstly, the origin of the document from the JRO(JRO), SPON will indicate that this is a Sponsor SOP and is for internal JRO use onlyor shared between the JRO and the investigators, the SOP number Example: (S01) and the version number example:(01)indicates the original document. Any further version change will be altered accordingly i.e. 02, 03. This information is referred to as the identity (ID) number of the SOP and will be recorded on the front page of the SOP in the table provided and in the footer of the SOP.
Please note: In a previous SOP the original document was numbered (00). The numbers for these SOPs will not be changed from 00 to 01.
File name of the e-versions:The file names of these SOPs and templates associated to these SOPs should be saved as SPON_S0X, so that the templates and actual SOPs can be identified easily.
3.3 Investigator SOPs:
These SOPs will outline processes and procedures specific to the Investigators and their teams in relation to clinical trial management at a site.
Each Investigator SOP will be issued with a unique SOP number e.g. (JRO/INV/S01/01) located in the table on the front page and in the footer of the document. This number identifies firstly, the origin of the document from the JRO(JRO), INV will indicate that this is an investigator only SOP, the SOP number (S01) and the version number (01). (01) indicates the original document. Any further version change will be altered accordingly i.e. 02, 03. This information is referred to as the identity number of the SOP and will be recorded on the front page of the SOP in the table provided and in the footer of the SOP.
File name of the e-versions:The file names of these SOPs and templates associated to these SOP should be saved as INV_S0X, so that the templates and actual SOPs can be identified easily.
3.4 Dates
Date of authorisation: this date refers to the date when the SOP is finalised and authorised for training and implementation by the authorised person. This date will be marked by the date the SOP is signed by both the author and the person authorised to sign off the SOP.
Effective date: this date refers to the date of implementing the use of the SOP. The effective date will allow sufficient time for training should the nature of the changes requires training.
Review date: this date refers to the date the SOP is up for review. This will be 2 years from the effective date. However this review date will on occasions need to be brought forward if there is a justification for the need of early revision.
3.5 Authorship:
The author of a SOP is the person who has been assigned the responsibility to write it or the person who has requested to write a new SOP in recognition that one is needed for a procedure not yet covered by those already existing. In situations where the named author no longer works at the JRO, the person who is responsible for updating the existing SOP will become the new named author. A history of authorship is maintained through the ‘Revision Chronology’ Table. Personnel invited to comment on SOPs do not automatically become joint authors, unless agreed by the lead author.
3.6 Authorisation of SOP:
This refers to the person who authorises the use of the SOP. This person is the Quality Assurance Manager or in his/her absence the Divisional Manager of the JRO. On occasions when both are unavailable, the Head of Clinical Trials will authorise the use of the SOP (unless he or she has authored the SOP).
4. SCOPE OF THIS SOP
This SOP relates to the preparation, review, approval, and revision of SOPs that are produced from JRO for UCL sponsored trials. This SOP covers “SOP dissemination and training” and entails aSOP TRAINING LOG.
5. RESPONSIBLE PERSONNEL
The Quality Assurance (QA) Manager will be responsible for the following, in relation to SOP production and management;
- Providing sequential SOP numbers for all Sponsor SOPs generated by the JRO
- Providing sequential SOP numbers for all Investigator SOPs generated by the JRO
- Reviewing and authorising all SOPs produced by the JRO ensuring that they are consistent with this SOP
- Maintaining a master copy of all signed, effective and archived SOPs on the shared server (S drive)
- Ensuring that all SOPs produced from the JRO are reviewed before the review date assigned on the SOP.
In the absence of the QAManager theDivisional Manager and/or Head of Clinical Trials for the JRO will have responsibility for reviewing and approving SOPs in accordance with this SOP.
6. PROCEDURE
6.1Use the UCL SOP Template available in theJRO website, and in_the_S:DrivefolderS:\CLINICAL_TRIALS\SOPs\EFFECTIVE_SOPs_Guides\SPONSOR SOPs\SPON_S01 SOPs on SOPs\SPON_S01_ SOP on SOPs c
6.2Issue the SOP ID number
The QA Manager will:
- issue the next sequential SOP ID number to be used,
SPON_SXX_SHORT NAME OF SOP_vYY_DRAFT.doc (for sponsor SOP), or
INV_SXX_SHORT NAME OF SOP_vYY_DRAFT.doc (for investigator SOP).
where XX is the SOP number, v refers to version and YY the version number.
6.3Layout and Format of SOP
The SOP template has been set to the required fonts and therefore will not need to be altered.
Footer: The footer of all SOPs must contain the short SOP title, SOP identifier and page X of Y. The footer in the master template SOP has been set with these requirements. For Sponsor SOPs the identifier will include “SPON” to indicate internal as per Section 2 of this SOP.
SOP on SOPs
JRO/SPON/S01/01
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Content of all SOPs
Title: Standard Operating Procedure on XYZ
Following the title of the SOP, the following headings and text inserts must be written in the order below. All headings throughout the SOP will be numbered numerically i.e.1.2. 3.Please see UCL SOP template for details of what needs to be in each section
1. PURPOSE
2. JOINT UCLH/UCL BIOMEDICAL RESEARCH UNIT POLICY
3. BACKGROUND
4. SCOPE OF THIS SOP
5. RESPONSIBLE PERSONNEL
6. PROCEDURE
7. REFERENCES
8. APPENDICES
9. TEMPLATES/LOGS ASSOCIATED TO THIS SOP
10. SOP DISSEMINATION AND TRAINING
11. SIGNATURE PAGE
12. SOP TRAINING LOG
6.4Next step following the first draft of the review
Once a draft JROSOP is ready for review, the author will send an email to the clinical trials team asking for review of the draft SOP. The email must state;
- the title of the draft SOP produced
- the location of the SOP
Following comments from the trials team, the author must review and either accept or reject the comments in consultation with the team and Head of Clinical Trials or the QA Manager.
6.5Final step of the SOP
Once the draft SOP is finalised, the author must send it to the QA Manager for final review and approval. The QA Manager will insert the effective date on the SOP (indicating the implementation date) along with the next review date. The SOP will need to be saved and to change the file name such that the word DRAFT is no longer part of it. Two versions of the same file will be needed a .doc version and a pdf version. Both versions will be saved in the EFFECTIVE SOPs and Guides Folder.
6.6Storing the SOP
The SOP must then be printed and signed and dated by the author and QA Manager. In the absence of the QA Manager, the Divisional Manager will sign and if he/she is unavailable this responsibility can be devolved to the Head of Clinical Trials if he/she has not authored that SOP. This will be the master copy and will be stored in a designated binder within the JRO.
Any further changes to the SOP after this point will have to be undertaken through the Document Control System.
7. REFERENCES (Do not forget the websites)
ICH Harmonised Tripartite Guideline for Good Clinical Practice (1996)
8. APPENDICES
9. TEMPLATES/LOGS ASSOCIATED TO THIS SOP: (Give websites where the most recent templates/logs can be obtained)
1 / UCL SOP TEMPLATE2 / Individual Staff SOP and courseslog
10. SOP DISSEMINATION & TRAINING
SOPs relevant to the JRO only, will be distributed to the concerned JRO 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 JROstaff has an “Individual Staff SOP and courses log” 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.
SOPs relevant to “JRO 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 “JRO 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 JRO SOP folder together with the relevant SOP.
The SOPs and relevant templates and logs will be available on the JRO 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: / Helen Cadiou, Quality Assurance ManagerSignature:
Date:
Authorised by:
Name and Job Title
Signature:
Date:
SOP on SOPs
JRO/SPON/S01/04
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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 trainingrequired) / Signature / Date
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SOP on SOPs
JRO/SPON/S01/04
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