STANDARD OPERATING PROCEDURE 24. Training Records

Transcription

1 STANDARD OPERATING PROCEDURE 24 Version: 1.4 Issue Date: 07 February 2018 Effective Date: 21 February 2018 Review Due: 21 February 2020 Author: Jill Wood, QA Manager WCTU WCTU Reviewers: Sponsor Reviewers: WCTU approval: Amy Ismay, QA Support Officer, WCTU Jaclyn Brown, Senior Project Manager, WCTU Mathew Gane, Research Governance & Quality Assurance Manager, R&IS Natalie Strickland, WCTU Manager Sponsor approval: Dr Catherine Cochrane, Director R&IS Review Lead: WCTU QA Team Page 1 of 5

2 Revision Chronology: Effective date: Reason for change: Version February 2018 Version th September 2015 Version th August 2013 Biennial review: Updated to new version of SOP template. Updated to reflect SOP sign off via Q-pulse. Minor amendments to text. Link added to UoW policy on retention of records. Included information regarding Epigeum research integrity online training. Biennial review: Updated to include reference to the University s Research Code of Practice To include provisions for archiving PDFs. August 2011 Version nd May 2009 Biennial review no changes. Biennial review. Minor changes to text regarding review process. Version rd April 2007 Page 2 of 5

3 1. Purpose This Standard Operating Procedure (SOP) describes the procedure for setting up and maintaining a Personal Development Folder (PDF) to ensure that all training is documented. 2. Background International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) and Medical Research Council (MRC) GCP guidelines both state that Each individual involved in conducting a trial should be qualified by education, training and experience to perform his or her respective task(s). (Section 2.8). To comply with these regulations, all research staff must maintain a complete record of their on-going personal development to demonstrate that they are competent to perform duties appropriate to their role in each study. 3. Procedure 3.1 Who? For studies managed within WCTU, the WCTU QA team will maintain an oversight of SOP sign off and compulsory training via Q-Pulse for WCTU staff members, however it remains the responsibility of each individual staff member to ensure they maintain and accurate and complete PDF. Line Managers or their delegate (e.g. QA Manager) should periodically check PDFs for completeness and sign and date the PDF Review Log. For studies being managed outside of WCTU, research staff should be able to demonstrate up to date training that is relevant to their role. As part of this, the University, via the Research Governance and Ethics Committee expects that all staff and students (and their supervisors) undertaking research, research ethics committee members and research support staff (technical and administrative) are strongly encouraged to complete the Epigeum online research integrity training, which is available via the following link: A copy of the certificate for this course should be kept within staff/ student training records. 3.2 When? A PDF should be set up for all new members of staff working on clinical trials. Folders should be updated on a regular basis and reviewed periodically for completeness. Training records should be available for inspection by internal or external parties at all times. 3.3 How? It is recommended that the following documents should be filed in the PDF: Introductory Documentation Signed Research Code of Practice Declaration Form (see section 3.3.1) Section 1: Induction Process Documentation Induction Plan Probation sign off Page 3 of 5

4 Section 2: Job Descriptions These should be present in ascending order and labelled with start and replacement dates Section 3: Full Curriculum Vitae (CV) This should be up-to-date for the role being performed, signed and dated Section 4: Internal training records Initial SOP sign off Protocol Sign-off /record of trial specific training Compulsory training IT training Divisional seminars Trial specific training (e.g. Protocol training, Data Management Training) Agendas/certificates (where available) Please note: For new SOPs that are published, sign off is performed and tracked via the Q-pulse system, therefore SOPs that have been read and signed off in this way do not need to be documented here. Section 5: External training records Events, courses, conferences not organised by the UoW Copy of request/authorisation to attend Details of Course/agenda Certificate of attendance (where available) Section 6: Publications Copies of publications Copies of conference presentations Copies of abstracts University of Warwick Research Code of Practice The University s Research Code of Practice and Declaration Form are included in the Introductory Documentation section of each newly-issued PDF. All staff must read the Code and sign the Declaration Form as soon as possible. The signed Declaration Form should then be photocopied, with one copy filed in the Introductory Documentation section in the individual s PDF and the other copy passed to the Quality Assurance (QA) team Retention of PDFs from WCTU staff leaving the University PDFs for study staff may be required for inspection purposes at any time, including after staff have left employment at the University. Therefore, when a member of WCTU staff leaves, their PDF will be requested by the QA Team for retention. Individual files will then be archived in a dedicated area within the Clinical Trials Unit s document storage area for a period of at least 5 years from the end date of the last study they worked on or longer as stipulated by the UoW policy: h_code_of_practice/datacollection_retention Page 4 of 5

5 List of Abbreviations ICH GCP International Conference on Harmonisation Good Clinical Practice MRC GCP Medical Research Council Good Clinical Practice PDF Personal Development Folder QA Quality Assurance R&IS Research and Impact Services SOP Standard Operating Procedure UoW University of Warwick WCTU Warwick Clinical Trials Unit Templates Template 24-1 Template 24-2 Template 24-3 Template 24-4 Template 24-5 Template 21-6 PDF Index PDF Review Log SOP Sign Off Form Internal Training Log External Training Log Protocol Sign-off Log Page 5 of 5