SOFTWARE DEVELOPMENT FOR CLINICAL RESEARCH COMPUTER SYSTEMS - SOP Number BTC-SOP-IT-001 - Version 3.0

Sep 12, 2026

This SOP defines the standard procedures for the new and ongoing development of Clinical Research Computer Systems by Bristol Trials Centre (BTC). It sets expectations for capturing, processing, managing, and reporting clinical study data in line with ICH GCP requirements for computerized systems and electronic trial data handling. The document covers purpose, scope, key definitions, roles and responsibilities, and specific procedures across the lifecycle. It also includes review, release and implementation dates plus change history and supporting materials.

LanguageEnglish

CategoryPresentations

FormatPDF

Pages10

Reading Time4 min

AccessFree to download

INTRODUCTION AND PURPOSE

SCOPE

DEFINITIONS

RESPONSIBILITIES

Sponsor or delegate

Chief Investigator (CI) or delegate

Lead Research Systems Technical Developer or delegate

Trial Manager/Co-ordinator

Study Statistician

SOP Author(s) or delegate

SOP user

SPECIFIC PROCEDURES

General Principles

Commissioning

User Requirements elicitation, analysis and definition

Pre-validation process

Implementation and coding

Testing

Computerised System Validation, Sign-off and release

SUPPORTING DOCUMENTS TO BE USED

CHANGE HISTORY

APPENDICES

Appendix 1 - Flow Chart of Process

SOFTWARE DEVELOPMENT FOR CLINICAL RESEARCH COMPUTER SYSTEMS SOP Number: BTC-SOP-IT-001 SOP Version: 3.0 Click here to record your training for this SOP | | NAME | TITLE | | --- | --- | --- | | Authors | David Carmichael, Martin House | Research Systems Technical Developer | | Reviewer | Matt Hewson | Quality Assurance Coordinator | | Authoriser | Melanie Lewcock | Head of BTC Strategy | | Release Date: | 13/04/26 | Implementation Date: | 28/04/26 | | --- | --- | --- | --- | | Review Due: | 28/04/28 | | --- | --- | Note to User: It is your responsibility to ensure that you are using the latest approved version of this SOP. Please note that versions may be superseded before their planned review date. THIS IS AN UNCONTROLLED VERSION WHEN PRINTED. If you are reading this document in printed form, please check that the version number and date match the most recent SOP’s details. Current versions of all Bristol Trials Centre (BTC) SOPs and accompanying documents are available on the BTC Teams QA channel. Contents 1. INTRODUCTION AND PURPOSE ......................................................................................... 3 2. SCOPE .................................................................................................................................. 3 3. DEFINITIONS ........................................................................................................................ 4 4. RESPONSIBILITIES .............................................................................................................. 4 4.1 Sponsor or delegate ........................................................................................................ 4 4.2 Chief Investigator (CI) or delegate................................................................................... 4 4.3 Lead Research Systems Technical Developer or delegate ............................................. 4 4.4 Trial Manager/Co-ordinator ............................................................................................. 4 4.5 Study Statistician............................................................................................................. 4 4.6 SOP Author(s) or delegate .............................................................................................. 5 4.7 SOP user ........................................................................................................................ 5 5. SPECIFIC PROCEDURES..................................................................................................... 5 5.1 General Principles ........................................................................................................... 5 5.2 Commissioning ............................................................................................................... 6 5.3 User Requirements elicitation, analysis and definition ..................................................... 6 5.4 Pre-validation process..................................................................................................... 6 5.5 Implementation and coding ............................................................................................. 7 5.6 Testing ............................................................................................................................ 7 5.7 Computerised System Validation, Sign-off and release ................................................... 8 6. SUPPORTING DOCUMENTS TO BE USED ......................................................................... 8 7. CHANGE HISTORY ............................................................................................................... 9 8. APPENDICES ...................................................................................................................... 10 8.1 Appendix 1-Flow Chart of Process ...........................................................

FAQs

What is the purpose of this SOP for BTC clinical research computer systems?

It describes standard procedures for developing clinical research computer systems to capture, process, manage, and report clinical study data in alignment with ICH GCP guidance for electronic data collection.

What does ICH GCP require regarding computerized systems and electronic trial data handling?

The SOP references requirements for documenting system conformance to established sponsor requirements (completeness, accuracy, reliability, intended performance), maintaining audit trails and security, managing authorized change access, backing up data, and safeguarding blinding when applicable.

Who is responsible for activities covered by this SOP?

Responsibilities are defined for the Sponsor or delegate, Chief Investigator or delegate, Lead Research Systems Technical Developer or delegate, Trial Manager/Co-ordinator, Study Statistician, SOP Author(s) or delegate, and the SOP user.

Sep 12, 2026

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