Standard Operating Procedure: Production, Review and Approval of Standard Operating Procedures

Transcription

1 NORTH Standard Operating Procedure: Production, Review and Approval of Standard Operating Procedures SOP Number: 1 Version Number & Date: / 09-Dec-2010 Superseded Version Number & Date (if applicable): V1.0/ , V2.0/ , V3.0/ Effective Date: 03-Feb-2011 (to allow sufficient lead-in time) Review Date: 03-Feb-2013 Author: Name: Caroline Campbell <Signature on File> 13/12/2010 Data Manager Signature Date Approved by: Name: Dr Marianne Nicolson <Signature on File> 14/12/2010 Clinical Lead for Research Signature Date Name: Dr Shelagh Bonner- <Signature on File> 20/12/2010 Shand Research Network Manager Signature Date BACKGROUND Standard Operating Procedures (SOPs) form part of the Scottish Cancer Research Network s (SCRN) Quality Management System and are written to ensure that clinical trials are conducted and data generated, documented and reported in compliance with the protocol, good clinical practice (GCP), and the applicable regulatory requirements (as per Section 5 of ICH GCP). Standard Operating Procedures (SOPs) are written instructions which aim to achieve uniformity in the performance of specific functions (as per Section 1.55 of ICH GCP) 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 the SCRN-North (SCRN-N) following consultation and discussion as appropriate. SOPs should be clear, concise, of common style, format and content, available where and when needed and be subject of a system of document control. Page 1 of 9

2 PURPOSE To describe the procedure for the production, review, approval, distribution and revision of SOPs for Clinical Research Team members (CRTM). ABBREVIATIONS CLR Clinical Lead for Research CRT Clinical Research Team CRTM Clinical Research Team members GCP Good Clinical Practice ICH The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) NOSCAN North of Scotland Cancer Network SCRN-N Scottish Cancer Research Network North SOP Standard Operating Procedure PROCEDURE 1. WHO? SOPs should be written by experienced members of the CRT (Clinical Research Team). The Scottish Cancer Research Network-North (SCRN-N) Research Network Manager is responsible for ensuring that SOPs are reviewed, revised, approved and issued according to this SOP. The SCRN-N Research Network Manager is responsible for: Implementing and/or managing a system of dissemination of SOPs and retrieval of superseded SOPs and maintain records of these activities. Maintaining the SOP Folder. Ensuring that any delegation of the SOP-related responsibilities listed here is documented and maintained in the SOP Folder(s). Informing relevant staff of the implementation of a new SOP or updates to existing SOPs. Ensuring that clinical research staff receive training in the implementation and application of SOPs. Notifying SOP authors that existing SOPs are due for scheduled review and providing support as necessary. The Clinical Lead for Research (CLR) and the SCRN-N Research Network Manager are responsible for approving all SOPs. Where the CLR or SCRN-N Research Network Manager is the author of the SOP, another suitably qualified and experienced individual should be designated to approve the SOP. Page 2 of 9

3 All CRTM are responsible for identifying any deficiencies in the SOPs and notifying the SCRN-N Research Network Manager. Each individual SOP will define the scope of responsibility. 2. WHEN? New SOPs An SOP should be written as soon as the need for a standard written procedure for an activity is identified. Routine Scheduled Review SOPs can become outdated as a result of changes in clinical practice and the regulatory environment. All SOPs should be peer reviewed three to six months after first implementation and every 2 years thereafter as an integrated part of clinical research practice. All such scheduled reviews should be documented as evidence that the review has taken place, even if it is decided that no amendments/updates to the SOP are necessary. Non-Scheduled Amendments Deficiencies requiring SOP amendments should be rectified at the earliest opportunity but no later than the next SOP review. Where an SOP needs to be updated to ensure regulatory compliance this should be implemented and addressed as soon as possible. 3. HOW? SOPs will be maintained in a specific file incorporating a contents page. Each research site should have an individually numbered SOP file. A central electronic file will be maintained. The contents page should be updated as new SOPs are prepared and as superseded SOPs are replaced. All SOPs should be prepared according to the standard format defined in Appendix A. A draft SOP will be produced by a member of the CRT who is competent and experienced to do so. The draft SOP will be clearly labelled as DRAFT in the header and Effective Date sections of the SOP to ensure that all staff are aware of the implementation status of the SOP. Each SOP should be reviewed at draft stage by CRTM, and any issues addressed. This should be done within 4 weeks of the draft SOP being sent for review. All CRTM must respond using Form 1, SOP review form (see Appendix B). The names of the author and the approver will be entered in the table on page 1. A master copy will be printed and maintained by the SCRN-N central office. Each site will receive a copy to file or will be given a link to its location on the North of Scotland Cancer Network (NOSCAN) website. Page 3 of 9

4 The author will sign and date the table on page 1 to document date of preparation. The Research Network Manager or designee and the CLR will conduct a final review of the SOP and once satisfied will authorise it by signing and dating the table on page 1 indicating date of approval. The Research Network Manager will enter effective from and review date at this stage. The Review date should be: The effective Date + 6 months for new SOPs The effective date + 2 years for existing SOPs A change in the review and effective date (page 1) will record when statutory review has been completed and no changes were required. Any revision of the SOP following review will be recorded with a new version number. Each SOP should indicate if it replaces a previous version and if so which. If the SOPs are to be made available electronically, the following text will be inserted in the Signature sections of the front page: <Signature on File> The SOP should be saved as a PDF which will ensure that any hyperlinks are retained. The original wet-ink SOPs will be retained in the SOP file at the SCRN-N central office. The maintenance of the SOP file will be the responsibility of the SCRN-N Research Network Manager. All SOPs should be reviewed every two years by the SOP Author and appropriate staff members (i.e., process owners) as identified by the SCRN-N Research Network Manager and SOP Author. During the review cycle, SOPs being amended should be listed as DRAFT and an effective and review date added by the Approvers as per the process for new SOPs. Deficiencies in SOPs should be recorded and notified as soon as possible to the SCRN-N Research Network Manager, who will arrange for appropriate SOPs to be prepared or existing ones modified to address these deficiencies. Superseded versions of SOPs will be returned to the SCRN-N Research Network Manager, who will document their return. Copies of superseded SOPs will be destroyed, and only the master copy (original wet-ink signature copy) retained and archived in order for regulatory bodies to review (as required). The SCRN-N central office will be responsible for, and manage a system of, dissemination of SOPs and retrieval of superseded SOPs and maintain robust records. The SCRN-N Research Network Manager/designee will be responsible for the training of clinical research staff in the implementation and application of SOPs. 4. OTHER RELATED PROCEDURES None Page 4 of 9

5 5. APPENDICES Appendix A Format for standard operating procedure documentation Appendix B SOP Review Form 6. REFERENCES ICH GCP ICH Harmonised Tripartite Guideline for Good Clinical Practice E6(R1) (CPMP/ICH/135/95), May 1996 Page 5 of 9

6 Appendix A FORMAT FOR STANDARD OPERATING PROCEDURE DOCUMENTATION Title page: Header (as below). NORTH Standard Operating Procedure: TITLE OF SOP SOP Number: Version Number & Date: Effective Date: Review Date: Superseded Version Number & Date (if applicable): Author: Name: <Insert Name> Position: <Insert Position> Signature Date Approved by: Name: <Insert Name> Clinical Lead for Research Signature Date Name: <Insert Name> Research Network Manager Signature Date The SOP should contain the following sections: BACKGROUND Briefly discuss the background to the procedure, making reference to legal requirements and national or international guidance. Consider the driving forces or why the procedure is necessary. PURPOSE Describe the procedure to be followed and the setting in which the SOP applies. ABBREVIATIONS Definition of all abbreviations used in the SOP. Page 6 of 9

7 PROCEDURE 1. WHO? Each SOP will define the scope of responsibility. 2. WHEN? Describe at what stage of clinical trial activity the SOP applies. 3. HOW? Standardised step-by-step description of the procedure to be followed. 4. OTHER RELATED PROCEDURES List of other SOPs referenced in the document, or related to the procedure. 5. APPENDICES List appendices attached to SOP in alphabetical order. 6. REFERENCES Hyperlinked list of references cited in the SOP. Page 7 of 9

8 Appendix A (Cont.) Header: Footer: Main Body Text: Heading/s: Line Spacing: SOP Number & Title Version number (version 1.0, 1.1, 1.2 etc) Version date Arial 11 font, black, centred Page X of Y (e.g. Page 1 of 3) Arial 11 font, bold, black Arial 11 font, black, not indented Arial12 font, bold, black, numbered (e.g. 1., 2., 3. etc) Single line spacing Margins: Top Margin 2 cm Bottom Margin 2 cm Left Margin 2.5 cm Right Margin 2.5 cm Gutter: From edge header: From edge footer: Justification: Bullet point 1: 0 cm 1 cm 0.5 cm On Normal bullet points (not arrows or boxes) Indented at 0cm, text position indented at 0.63cm Bullet point 2: Dash bullet point - Indented at 0.5cm, text position indented at 1.2cm Paper size: A4 SOP Review Form as an appendix to this SOP. More guidelines on version number control. Page 8 of 9

9 Appendix B SOP Review Form SOP Review Form NORTH SOP: Section Comment Background Purpose Abbreviations Who When How Appendices References Name: Date: Page 9 of 9