SOP10v2 typed names - Accord - University of Edinburgh

ACCORD/ECTUSOP Number: ACCORD/ECTU/SOP10/2.0NHS Lothian R&D and Version: 2.0The University of Edinburgh Effective Date: 27/10/2008STANDARD OPERATING PROCEDURE FOR ESTABLISHINGAND MAINTAINING A TRAINING RECORDSOP NUMBER:ACCORD/ECTU/SOP10/2.0VERSION NUMBER: 2.0PREVIOUS VERSIONS: 1.0EFFECTIVE DATE: 27/10/2008REVIEW DATE: 26/10/2010AUTHOR:Fiona Sloan (Clinical Trials Monitor)APPROVED BY (1):.....Tina.McLelland...................................(R&D Governance Manager, NHS Lothian)DATE APPROVED: 24/10/2008APPROVED BY (2):..... Anne.Langston................................(Associate Director, ECTU, University of Edinburgh)DATE APPROVED: 23/10/2008RELEASED BY:.....Alex.MacLellan........................................(QA Manager, ECMC, University of Edinburgh)DATE RELEASED: 24/10/2008Controlled Document – Do Not CopyPage 1 of 5

ACCORD/ECTUSOP Number: ACCORD/ECTU/SOP10/2.0NHS Lothian R&D and Version: 2.0The University of Edinburgh Effective Date: 27/10/2008DOCUMENT HISTORYVersion Edited by (job title):Number:2.0 Alex MacLellan (QAManager)1.0 Fiona Sloan (ClinicalTrials Monitor)Effective Details of editions made:Date:27/10/2008 Format changes as per SOP01,minor text changes.19/04/2007 New1. PURPOSETo describe the procedure for establishing and maintaining training records for allstaff involved in clinical research in NHS Lothian and/or the University of Edinburgh.2. APPLICABILITYApplies to all researchers participating in or running research studies sponsored byNHS Lothian and/or the University of Edinburgh.Applies to all members of the ACCORD office who have responsibility for managingor advising on research studies undertaken in NHS Lothian and/or the University ofEdinburgh.3. POLICYAll staff involved in clinical research conducted within NHS Lothian and/or theUniversity of Edinburgh will be appropriately qualified by education, training andexperience to carry out his or her respective tasks in accordance with the principlesof GCP and the Research Governance Framework for Health and Social Care. Allstaff involved in clinical research within NHS Lothian and/or the University ofEdinburgh will be able to provide evidence of this education, training and experienceby establishing and maintaining a training record. This training record will be madeavailable for review during any internal or external audits as appropriate.All training undertaken by NHS staff should be carried out in conjunction with NHSpolices and procedures.4. PROCEDURE4.1 ESTABLISHING A TRAINING RECORD4.1.1 It is the responsibility of the individual to establish his or her own trainingrecord.4.1.2 A training record should be established within one month of startingemployment in clinical research.4.1.3 New staff should establish a training record according to the ACCORD/ECTUtraining record guidance (see section 4.2 and attachment 1).Controlled Document – Do Not CopyPage 2 of 5

ACCORD/ECTUSOP Number: ACCORD/ECTU/SOP10/2.0NHS Lothian R&D and Version: 2.0The University of Edinburgh Effective Date: 27/10/20084.1.4 New staff that have previously worked in clinical research and have a trainingrecord from their previous employment should update their existing trainingrecord with a revised CV and new job description.4.2 CONTENT OF A TRAINING RECORD4.2.1 A training record should contain, as a minimum, the following documents;• Current CV - this should be signed and dated and include current position• Current job description• Previous job descriptions – to be provided if detail of previous posts notalready given in CV• Training Log – the training log is an ongoing, cumulative list of all internal andexternal training. Training undertaken in a previous post may also beincluded. In addition to formal training courses, attendance at seminars,forums and relevant meetings should be recorded in the training log.• Original certificates from all courses attended.• SOP signature review pages – copies of signed SOP signature review pagesshould be kept in the training record, originals will be kept by the SOPmanager.4.3 MAINTAINING A TRAINING RECORD4.3.1 It is the responsibility of the individual to ensure that his or her training recordis kept up-to-date and reviewed appropriately.4.3.2 The training record should be updated each time the individual attendstraining courses, seminars, forums or if their job description changes.4.3.3 Training records should be kept in a secure but accessible manner andshould be available for review by the Clinical Trials Monitor and/or regulatoryauthorities as appropriate.4.3.4 Training records should be taken with individuals if they leave their currentemployment. A photocopy of the training record should be left with theprevious manager in case of future audit or inspection.5. ATTACHMENTS1. Training log template6. DEFINITIONSACCORDECTUAcademic and Clinical Central Office for Research and Development).The ACCORD office is a collaboration between NHS Lothian and theUniversity of Edinburgh to form a joint research and developmentoffice to facilitate clinical research.Edinburgh Clinical Trials UnitControlled Document – Do Not CopyPage 3 of 5

ACCORD/ECTUSOP Number: ACCORD/ECTU/SOP10/2.0NHS Lothian R&D and Version: 2.0The University of Edinburgh Effective Date: 27/10/20087. REFERENCESThe Medicines for Human Use (Clinical Trials) Regulations 2004, (SI 2004 No. 1031).The Medicines for Human Use (Clinical Trials) Amendment Regulations 2006, (SI2006 No. 1928).Good Clinical Laboratory Practice (GCLP), BARQA 2003.Declaration of Helsinki, Clarification of 5 th Revision, 2004.Research Governance Framework for Health and Social Care, Second Edition (2005)Research Governance Framework for Health and Community Care, Second Edition(2006)National Cancer Research Network SOP number 13 (version 2, 01/07/2005),“Performing and Documenting Training for Researchers”Controlled Document – Do Not CopyPage 4 of 5

ACCORD/ECTUSOP Number: ACCORD/ECTU/SOP10/2.0NHS Lothian R&D and Version: 2.0The University of Edinburgh Effective Date: 27/10/2008ATTACHMENT 1TRAINING LOGTrainingdate(s)TrainingproviderType oftraining/activity(e.g.internal/external,workshop,conference,seminar etc)TrainingcoveredSignature oftrainer(if applicable)Controlled Document – Do Not CopyPage 5 of 5