SOP22a: Standard Operating Procedure for Data …

1 Canolfan Hap-dreialon Iechyd Gorllewin Cymru yn Abertawe West Wales Organisation for Rigorous Trials in Health (WWORTH) the Clinical Trials Unit in Swansea Prifysgol Abertawe Coleg Meddygaeth Swansea University College of Medicine Athrofa Gwyddor Bywyd 2, Parc Singleton Institute of Life Science 2, Singleton Park Abertawe SA2 8PP Swansea SA2 8PP Ffon (01792) 606545 Ebost Phone (01792) 606545 Email _____ Page 1 of 14 Not guaranteed if printed sop22a : Standard Operating Procedure for data Collection and Management Authorship Team.

2 Mel Storey and Stephen Allen for Joint SOP Group on Trial Techniques (viz Helen Snooks, Ian Russell, Bridget Wells, Frances Rapport, Julie Peconi, Moira Morgan, Simon Thompson, Sian Davies, Sinead Brophy, Steve Allen, Ceri Phillips) Approved by WWORTH JMG (Ian Russell in chair) Signature Date 07 May 2014 0 Version Record Version Number Effective Date Reason for Change 0 SOP approved by NWORTH 04 Mar 2009 Adapted SOP discussed by JSOPG 01 Apr 2009 Reviewed by JSOPG 07 Jul 2009 Comments for review at JMG by KT 15 Jul 2009 Amendment to SOP post-JMG review 07 Aug 2009 Further amendments 15 Sep 2009 Amendments to SOP following 2nd JMG review for final approval by KT 16 Sept 2009 Approved in principle 15 May 2010 Minor formatting amendments 19 Apr 2012 Minor formatting amendments, addition of training section.

3 Prepare SOP for JSOPG by MS. Egs in use CONSTRUCT, SAFER2, PRISMATIC, PROBAT 21 May 2012 Minor amendments following JSOPG 31 May 2012 Authorised for use by JMG 06 Jun 2013 Update header and formatting amendments 15 Jan 2014 Edits by MS. Inclusion of MACRO 4 software, 07 May 2014 Remove training log post JSOPG discussion - MS & CS Canolfan Hap-dreialon Iechyd Gorllewin Cymru yn Abertawe West Wales Organisation for Rigorous Trials in Health (WWORTH) the Clinical Trials Unit in Swansea Prifysgol Abertawe Coleg Meddygaeth Swansea University College of Medicine Athrofa Gwyddor Bywyd 2, Parc Singleton Institute of Life Science 2, Singleton Park Abertawe SA2 8PP Swansea SA2 8PP Ffon (01792) 606545 Ebost Phone (01792)

4 606545 Email _____ Page 2 of 14 Not guaranteed if printed 1 Table of Contents 0 Version Record .. 1 1 Table of Contents .. 2 2 Glossary .. 3 3 3 4 Purpose .. 3 5 Roles and Responsibilities .. 4 6 procedures .. 6 Procedural Flowchart .. 6 data Collection .. 7 data analysis plan .. 7 Database design .. 9 data Management ..10 data transfer .. 10 data storage .. 10 data security .. 11 Post collection data validation .. 11 Quality Assurance ..11 End of trial ..12 7 Training Plan ..12 8 References ..13 9 Related SOPs.

5 14 Canolfan Hap-dreialon Iechyd Gorllewin Cymru yn Abertawe West Wales Organisation for Rigorous Trials in Health (WWORTH) the Clinical Trials Unit in Swansea Prifysgol Abertawe Coleg Meddygaeth Swansea University College of Medicine Athrofa Gwyddor Bywyd 2, Parc Singleton Institute of Life Science 2, Singleton Park Abertawe SA2 8PP Swansea SA2 8PP Ffon (01792) 606545 Ebost Phone (01792) 606545 Email _____ Page 3 of 14 Not guaranteed if printed 2 Glossary The full Glossary is in Swansea University H drive/Documents/526-WWORTH/Development Group/Glossary.

6 3 Introduction Standard Operating procedures (SOPs) are succinct formal documents designed to achieve consistency in specified trial functions by specifying Standard practice in performing those functions (GCP & EMeA, 2002). While SOPs should cite relevant legislation & regulations, and key references & evidence, they need not expound theory. WWORTH SOPs should accord with all relevant regulations, including the European Union Clinical Trial Directive1, ICH Good Clinical Practice (GCP)2 and the current NHS Research Governance Framework3.

7 They will seek to distinguish between regulations for CTIMPs and for other research. This document describes the principles for collecting and managing data in trials. We are grateful to colleagues in the North Wales Organisation for Randomised Trials in Health for access to their SOP on data Management (NWORTH, 2007). The overall aim of this SOP is to ensure that data management procedures : manage personal data from trial participants in a legally responsible manner result in error-free, high quality trial data for analysis are efficient and cost-effective All staff must comply with the data Protection Act (1998)4 and should comply with the MRC s code on Personal Information in Medical Research5.

8 All staff are required to have read these documents, agree to uphold their principles and sign a log after completion of training in this SOP. 4 Purpose The purpose of this SOP is to define the major processes in the collection and management of trial data held by each trial or on behalf of WWORTH and the responsibilities of individuals involved. It also aims to describe good practice in trial data collection and management techniques. This SOP should be used when any form of data is collected, accessed, transferred or stored by a trial.

9 MACRO 4 is the single data management system that will centralise, automate, streamline and enhance the process of data collection whenever possible (WWORTH SOP 21 IT Databases). Canolfan Hap-dreialon Iechyd Gorllewin Cymru yn Abertawe West Wales Organisation for Rigorous Trials in Health (WWORTH) the Clinical Trials Unit in Swansea Prifysgol Abertawe Coleg Meddygaeth Swansea University College of Medicine Athrofa Gwyddor Bywyd 2, Parc Singleton Institute of Life Science 2, Singleton Park Abertawe SA2 8PP Swansea SA2 8PP Ffon (01792) 606545 Ebost Phone (01792)

10 606545 Email _____ Page 4 of 14 Not guaranteed if printed It should inform protocol development (see WWORTH SOP13 Protocol Development) and trial methods. Types of data can include the following: 1. Pre-consent data (including basic, non-identifiable participant identification details held at trial sites but not by the Trial Office) 2. Post-consent data (interviews, questionnaires, laboratory results, etc.) Random allocation information (held at research sites and at WWORTH; see WWORTH SOP24 Randomisation). 5 Roles and Responsibilities The personnel responsible for using and implementing this SOP are listed below.