STANDARD OPERATING PROCEDURE FOR PHLEBOTOMY ROOM SOPs: Preparing, Maintaining and Training

Transcription

1 STANDARD OPERATING PROCEDURE FOR PHLEBOTOMY ROOM SOPs: Preparing, Maintaining and Training SOP Number: Phleb Version Number & Date: 3 rd version; 28 Feb 2011 Superseded Version Number & Date (if applicable): Supersedes version Oct 2009 Effective Date: Review Date: Revision Chronology: Version Number Version Date Reason for Change Apr 2007 Initial Version Oct 2009 Revision Feb 2011 Review; Change review period Printed Name Signature Date (dd/mmm/yyyy) Written By: Shayna McKay / / Reviewed By: Sandra Halko / / Approved By: Grace Parraga / / Page 1 of 5 28 Feb 2011

2 1. INTRODUCTION & PURPOSE This standard operating procedure (SOP) describes the preparation and maintenance of the written procedures that this research team follows to ensure compliance with all Health Canada and University of Western Ontario Health Sciences Research Ethics Board regulations and guidelines, as well as the policies and procedures of the University of Western Ontario for all testing conducted at this investigative site. This SOP also describes procedures for training on SOPs and documentation of training. 2. SCOPE This SOP applies to the written procedures followed by this research team as it conducts all clinical research. 3. APPLICABLE REGULATIONS AND GUIDELINES Health Canada: Laboratory Biosafety Guidelines: 2004 National WHMIS Compliance Policy: 3 January 2002 University of Western Ontario: Health Sciences Research Ethics Board for Research Involving Human Subjects Guidelines: July 2001 Personal Health Information Protection Act (PHIPA): 1 November 2004 Guidelines for the Monitoring of Clinical Investigations: January 1988 FDA Compliance Program Guidance Manual : Clinical Investigators: September 1993 International Conference on Harmonisation; Good Clinical Practice: Consolidated Guidelines: May REFERENCES TO OTHER APPLICABLE SOPs This SOP is applicable to all Phlebotomy Room SOPs All SOPs on Good Clinical Practices are applicable to this SOP 5. ATTACHMENTS A. Training Compliance Form B. SOP Log Page 2 of 5 28 Feb 2011

3 6. RESPONSIBILITY It is the responsibility of the principal investigator at this investigative site to approve all SOPs. The principal investigator assumes ultimate accountability for all SOPs. It is the responsibility of all members of the clinical research team involved in supervising, managing or conducting study-related activities to follow the SOPs. This includes (but is not limited to) the following: Principal, Qualified and Co- Investigators Collaborators Research Assistants, Associates and Technicians Students 7. DEFINITIONS The following definitions apply to this SOP: Clinical Trial/Study: Any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of an investigational product(s), and/or to identify any adverse reactions to an investigational product(s), and/or to study absorption, distribution, metabolism, and excretion of an investigational product(s) with the object of ascertaining its safety and/or efficacy. Standard Operating Procedures (SOPs): Detailed, written instructions to achieve uniformity of the performance of a specific function. 8. PROCESS OVERVIEW A. Procedure for preparing new SOPs or revising previously issued SOPs B. Procedure for reviewing SOPs C. Procedure for providing training on new and revised SOPs Page 3 of 5 28 Feb 2011

4 9. PROCEDURES A. Procedure for preparing new SOPs or revising previously issued SOPs Based on the regulations and guidelines listed in Section 3, write a new SOP or revise a previously issued SOP that describes the new or revised procedures. Each SOP must include the following information on the first page: The title The number for that SOP The date of the current version The date of the previous version (for revisions) A log of all previous versions of that SOP The number of pages in the SOP The date by which the SOP must be reviewed Each SOP will have the following format: Introduction and Purpose Scope Applicable Regulations and Guidelines References to Other Applicable SOPs Attachments Responsibility Definitions Process Overview Procedures Review draft SOP to ensure accuracy and compliance Approve, sign and date each new/revised SOP after it is finalized Distribute new SOP to all team members. Collect superseded version, if applicable. Maintain a distribution list. Maintain an archive of all previously approved versions of SOPs to be available in the event of an audit. Page 4 of 5 28 Feb 2011

5 B. Procedure for reviewing SOPs At least every two years, review all Phleb SOPs. If revisions are required, follow the procedures described above. If no changes are required, document and file with archive of previously approved SOPs. C. Procedure for providing training on new and revised SOPs Provide training to all members of the research team within one month of a new or revised Phleb SOP becoming effective. Ensure that all personnel document the date of training on each SOP (using Attachment A, Training Compliance Form). Ensure that new personnel review all applicable Phleb SOPs prior to undertaking any responsibilities at this site for which the Phleb SOPs apply. Ensure that new personnel document the date of training and the relevant SOPs (using Attachment A, Training Compliance Form). Maintain a record of SOP training and review for all personnel at this site. Page 5 of 5 28 Feb 2011