1. INTRODUCTION 2. SCOPE 3. PROCESS

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2 1. INTRODUCTION This document describes the procedure for establishing and maintaining records for staff training and complies with the principles of good clinical practice (GCP) for clinical trials of investigational medicinal products (CTIMPs). 2. SCOPE Unless otherwise specified in a clinical trial site agreement, this document applies to CTIMP s sponsored or co-sponsored by the NUH, where written confirmation of sponsorship was confirmed on or after 1st November The site agreements for studies sponsored by organisations other than NUH but which involve NUH, staff or facilities should make reference to a GCP-compliant SOP. This SOP is aimed at all Chief Investigators (CIs), Principal Investigators (PIs), managers of clinical trials, researchers, trial co-ordinators and supervisors who are responsible for staff training records and/or the delegation of duties within a clinical trial. 3. PROCESS All staff employed in the conduct of a clinical trial that is sponsored, or co-sponsored by NUH and another organisation, will maintain up-to-date training records to ensure that all staff allocated duties within a clinical trial are qualified by education, training and experience to perform their delegated tasks. Procedure 1. A Training Record must be kept for each member of staff involved with establishing and running a clinical trial. 2. The location of the Training Records should be made clear in the Trial Master File. Training Records must be available for inspection as required by regulatory and other relevant authorities. 3. It is the responsibility of the CI/PI to ensure that all staff allocated duties on the Delegation of Responsibility Log are suitably trained in activities linked to those duties. 4. All research staff working on clinical trials sponsored or co-sponsored by NUH must be conversant with requirements of ICH Good Clinical Practice (GCP) and aware of any applicable regulatory requirements pertaining to clinical trial conduct, before the study commences. Specifically each staff member is to attend a GCP course at the first opportunity on commencing Page 2

3 work involved with clinical trials. Documented proof of attendance must be kept in the Training Record. 5. Staff should be conversant with changes to legislation that require GCP or other training to be updated. It is expected that GCP training will be renewed every two years. 6. The CI/PI and other appropriate departmental staff can initially arrange training on trial specific procedures but staff are encouraged to be pro-active with regard to their own training. 7. No member of staff is to be allowed to conduct trial visits or clinical trial participant appointments without appropriate training. Staff are to observe trial procedures, read the relevant SOPs, be closely supervised when carrying out procedures themselves and only be signed-off as trained when fully capable of working without supervision. How long this will take is dependent on the individual and the emphasis will be on quality of work and not speed of learning. 8. Training records must be reviewed regularly to identify gaps. If a member of staff feels that he or she requires extra training on procedures, arrangements should be made to provide this training. Refresher courses are to be arranged on procedures where expertise may have lapsed. 9. On permanently leaving the employment of NUH, staff members may take their training records with them. However, a full copy must be retained along with other trial documentation until the trial s document archiving period (usually five years) has expired. 10. See Appendix I for an example of a Training Record. SOP REVIEW PERIOD This procedure will be reviewed by the owner on a biennial basis, unless new local, national and/or international recommendations force an earlier review. Page 3

4 APPENDIX 1 TRAINING LOG NUH R&D Department Name: Date commenced in team: Date of Study/ Course Training/Reading/Online course/cme/meeting Verified by Certificate or Manager Comments NUH R&D Department Training Log Version 1, August 2009 In Accordance with SOP 19 - Training and Completion/Maintenance of Training Records Page 4

5 APPENDIX 2 RESEARCH STAFF FAMILIARISATION LOG NUH R&D Department Name: Date commenced in team: SOP Title / Number / Version Superseded SOP Title / Number / Version Staff Signature Manager Signature NUH R&D Department SOP Familiarisation Log Version 1, August 2009 In Accordance with SOP 19 - Training and Completion/Maintenance of Training Records Page 5