Standard Operating Procedure CPFT/SOP006 GCP Training Procedure for Clinical Trial Staff

Transcription

1 Standard Operating Procedure CPFT/SOP006 GCP Training Procedure for Clinical Trial Staff Author: Sponsor/Executive: Responsible committee: Ratified by: Consultation & Approval: (Committee/Groups which signed off the policy, including date) This document replaces: Research and Development Medical Director Date ratified: 13/9/2018 Date issued: Review date: 13/9/2020 Version: 1 Policy Number: Purpose of the Policy: If developed in partnership with another agency, ratification details of the relevant agency Policy in-line with national guidelines: Research and Development Operations Committee Research and Development Operations Committee Research and Development Operations Committee CPFT/SOP006 This SOP describes Good Clinical Practice training procedure for all staff undertaking clinical trials Sponsored by CPFT

2 Version Control Page Version Date Author Comments 1.0 September 2018 Jane Gaffa 2

3 Contents. Section Page 1 Introduction 4 2 Purpose 4 3 Scope 4 4 Definitions 4 5 Duties 5 6 Items Required 5 7 Method 5 8 Process for Monitoring Effective Implementation 6 9 References and Acknowledgements 6 Appendices 1 Introduction 3

4 The Joint research office; Cambridgeshire and Peterborough NHS Foundation Trust and Cambridge University NHS Foundation Trust organises training courses on the principles of Good Clinical Practice (GCP). The training is based on the ICH GCP guidelines together with the Medicines for Human Use (Clinical Trials) Regulations 2004 SI 2004/1031, and subsequent amendments. 2 Purpose To ensure that all staff working on Clinical Trials have appropriate good clinical practice training. GCP 2.1 Clinical Trials should be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki, and that are consistent with GCP and the applicable regulatory requirement(s). 3 Scope Clinical Trial Staff employed by The Trust or holding an honorary contract with The Trust. 4 Definitions The headings below contain the definitions of terms and meaning of abbreviations used within the document. Common abbreviations and definitions can be found in CCTU/INF001 Common Abbreviations and Definitions 4.1 Definitions Term Trust-Sponsored Epigeum GCP Clinical Trial/Study GCP 1.12 Definition Sponsored by Cambridgeshire and Peterborough NHS Foundation Trust (CPFT)or sponsored by CPFT jointly with The University of Cambridge On line GCP training provider Good Clinical Practice 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 ascertain if its safety and/or efficacy. The terms clinical trial and clinical study are synonymous. 4.2 Abbreviations Abbreviation NIHR Meaning National Institute for Health Research 4

5 5 Duties All staff working in clinical trials sponsored by or being conducted within The Trust 6 Items Required R&D/FRM001 Transfer of Expenditure Request Form GCP registration form 7 Method The following sections provide a description of the processes to be followed when implementing this document s procedures. 7.1 Trust Requirements It is a Trust requirement that all staff involved in clinical trials undertake GCP (Good Clinical Practice) training every two years. The Trust accepts certification of training done in the last two years for staff new in the Trust. There are different pathways for GCP training for CPFT staff. 7.2 R&D Tutor-led GCP Training Training dates and Registration Form can be found on the CUH R&D Website Complete a payment form R&D/FRM001 To book a place send completed paperwork to R&D box 277 or contact R&D (sylvie.robinson@addenbrookes.nhs.uk) 7.3. Online EPIGEUM GCP Training Register with EPIGEUM Registration and costs are automatically covered by R&D for holders of a CUH Honorary Contract or Letter of Access. Conditions of Booking for Online EPIGEUM Training; You hold an honorary contract with the CUHFT and have an Addenbrooke s account 7.4 NIHR Tutor-led GCP Training Details about the NIHR Eastern GCP training can be found via: NIHR Online GCP training Access to NIHR Learn is openly available to NHS, UK universities, and other publicly funded organisations conducting and supporting clinical research Evidence of Training Forward a copy of the training certificate to R&D Retain the original in personal training file File a copy according to local procedure if appropriate 5

6 8. Monitoring Compliance a. Process for Monitoring Compliance and Effectiveness As part of routine monitoring visits, audit and inspection b. standards/key Performance Indicators This process forms part of a quality management system. Documents are reviewed every two years 9. References and Acknowledgements The Institute of Clinical Research, 2008, Abbreviations used in Clinical Trials 6