Standard Operating Procedures (SOP) Research and Development Office Title of SOP: Maintaining Training Records SOP Number: 20 Version Number: 2.0 Supercedes: 1.0 Effective date: August 2013 Review date: August 2015 Author: Approved by: Alison Murphy, Research Manager Endorsed by Paul Carlin Dr David Hill Signed: Date: 01 August 2013 Page 1 of
Version History: Version No. Date Author Reason for Change 1.0 Sept 2007 Katrina Hughes N/A 2.0 Aug 2011 Alison Murphy Revised to reflect new format for SOPs. Additions of Staff Training Log to appendix Page 2 of
Table of Contents 1. Introduction 2. Objective 3. Scope 4. Procedure 4.1 Creation of Training Record File 4.2 Content of a Staff Training Record 4.3 Updating of Training Record File 4.4 Archiving of Training Record File 5. Regulations, Guidelines, References, SOP Links etc.. Appendices.1 Staff Training Log Page 3 of
1. INTRODUCTION The EU Clinical trials Directive 2001/20/EC, EU Good Clinical Practice Directive 2005/28/EU and The Medicines for Human Use (Clinical Trials) Regulations 2004 require clinical trials to be conducted according to the principles of Good Clinical Practice (GCP). Staff working on research studies must ensure that they are familiar with the requirements of Good Clinical Practice and that they maintain their own training records to show that all members of the trial team are qualified by education, training and experience to perform his or her respective task(s) (ICP GCP 2.8) All training undertaken by the study s staff must be carried out in conjunction with associated Trust policies and procedures. 2. OBJECTIVE The objective of this Standard Operating Procedure (SOP) is to describe the process for maintaining training records. 3. SCOPE This SOP applies to all South Eastern Health and Social Care Trust staff carrying out clinical research or related activities 4. PROCEDURE The following procedure should be used for maintaining training record files: 4.1 Creation of Training Record File All members of staff should have their own training record file. An individual s line manager or the Chief Investigator/Principal Investigator is responsible for ensuring a training record file is established for a new member of staff. The responsibility for the set up and maintenance of a training record file containing the items as stated in section 4.2 lies with the individual. 4.2 Content of a Staff Training Record An individual s training record should contain the following Page 4 of
Current Job description and any previous job descriptions which are relevant to the current post. It is important to add the dates of these positions if they are not noted in the curriculum Vitae (CV). Current CV which demonstrates education, training, qualifications and experience to date. Training record logs, both current and previous training record logs. These should list all training that the individual has undertaken which shows that they are able to undertake the responsibilities delegated to them in a study. (See appendix 1) Certificates of course attendance and agenda of courses/meetings. These may by photocopies or originals. Details of any relevant training conducted prior to appointment, which may not be listed in the current CV. 4.3 Updating of Training Record File It is responsibility of individual members of staff to maintain their own training record file on an ongoing basis. The staff member s manager should review the training annually to ensure completeness and to identify possible future training needs. An individual should ensure their training record file is available for audits and inspections. 4.4 Archiving of Training Record File When an individual member of staff leaves their employment, they can take their training record file with them. A copy of the training record file should be taken and archived by the CI with the date of leaving added to the CV. The copies should be kept for 5 years or as stipulated by protocol and/or sponsor agreement with the archived documents. 5. REGULATIONS, GUIDELINES, REFERENCES, SOP LINKS etc. ICH-GCP (199) EU directive on clinical trials (2001/20/EC) EU Good Clinical Practice Directive 2005/28/EC The Medicines for Human Use (Clinical Trials) regulations 2004 Page 5 of
. APPENDIX.1 Appendix 1: Staff Training Log.1 Appendix 1 Staff Training Log Name: Position: Training Session Provided by Date Review Date Page of