Data Management SOP - Purpose

Sep 2, 2026

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Standard Operating Procedure outlining data management requirements for clinical research projects, including responsibilities across sponsor roles, chief investigator oversight, and potential delegation to clinical trials units or trial teams. Defines the SOP’s scope across University of Birmingham-sponsored studies, external sponsor studies subject to contract consistency, and projects mandated by UoB research ethics committee principles. Establishes implementation timing, stakeholder expectations, and background rationale emphasizing robust, ALCOA+ compliant data handling and reliable reporting.

LanguageEnglish

CategoryGeneral

FormatDOCX

Pages14

Reading Time5 min

AccessFree to download

Purpose

Scope

Implementation plan

Stakeholders

Background

Standard Operating Procedure: data management Access the HYPERLINK "https://www.birmingham.ac.uk/research/activity/mds/mds-rkto/governance/e-pathway/overview.aspx" \o "Link to the Clinical Research e-Pathway" Clinical Research e-Pathway for a roadmap to help navigate a complete project lifecycle. Contents TOC \o "1-3" \h \z \u HYPERLINK \l "_Toc215130790" Purpose PAGEREF _Toc215130790 \h 3 HYPERLINK \l "_Toc215130791" Scope PAGEREF _Toc215130791 \h 3 HYPERLINK \l "_Toc215130792" Implementation plan PAGEREF _Toc215130792 \h 3 HYPERLINK \l "_Toc215130793" Stakeholders PAGEREF _Toc215130793 \h 3 HYPERLINK \l "_Toc215130794" Background PAGEREF _Toc215130794 \h 4 HYPERLINK \l "_Toc215130795" Procedure PAGEREF _Toc215130795 \h 5 HYPERLINK \l "_Toc215130796" 1. Set-up of data management processes PAGEREF _Toc215130796 \h 5 HYPERLINK \l "_Toc215130797" Define data management processes PAGEREF _Toc215130797 \h 5 HYPERLINK \l "_Toc215130798" Develop data management tools PAGEREF _Toc215130798 \h 5 HYPERLINK \l "_Toc215130799" Set up and maintain study/trial systems PAGEREF _Toc215130799 \h 7 HYPERLINK \l "_Toc215130800" 2. Data collection and processing PAGEREF _Toc215130800 \h 8 HYPERLINK \l "_Toc215130801" 3. End of data collection PAGEREF _Toc215130801 \h 8 HYPERLINK \l "_Toc215130802" List of expected outputs PAGEREF _Toc215130802 \h 9 HYPERLINK \l "_Toc215130803" Study/trial systems PAGEREF _Toc215130803 \h 9 HYPERLINK \l "_Toc215130804" Related documents PAGEREF _Toc215130804 \h 10 HYPERLINK \l "_Toc215130805" Associated QMS documents PAGEREF _Toc215130805 \h 10 HYPERLINK \l "_Toc215130806" Additional QMS documents PAGEREF _Toc215130806 \h 10 HYPERLINK \l "_Toc215130807" References & frameworks PAGEREF _Toc215130807 \h 10 HYPERLINK \l "_Toc215130808" Abbreviations PAGEREF _Toc215130808 \h 11 HYPERLINK \l "_Toc215130809" Document contributors PAGEREF _Toc215130809 \h 12 HYPERLINK \l "_Toc215130810" Document history PAGEREF _Toc215130810 \h 13 HYPERLINK \l "_Toc215130811" Document version log PAGEREF _Toc215130811 \h 13 HYPERLINK \l "_Toc215130812" Document revision log PAGEREF _Toc215130812 \h 13 Purpose This standard operating procedure (SOP) describes the data management procedures that need to be followed for a clinical research project. Scope This SOP applies to: (1) clinical research sponsored by the University of Birmingham (UoB); (2) clinical research sponsored by another institution, except to the extent that the SOP is inconsistent with any contract between UoB and that institution; and (3) clinical research approved by a UoB research ethics committee (REC) in circumstances where the REC requires that the clinical research conform with the UoB Principles of Good Clinical Practice (GCP) for Clinical Research (UoB-GCP-POL-001). Where this SOP does not apply, the chief investigator (CI) of a clinical research project may at their discretion refer to it as a non-binding source of guidance. Implementation plan This SOP will be implemented in line with this document’s effective date, with the exception of procedural points 1.18, 1.22 and 3.5 that will be subject to a three-month implementation period. Stakeholders Note that where the UoB takes on the sponsor’s responsibility for data management, the UoB will delegate the majority of these duties to the chief investigator (CI) or to a clinical trials unit (CTU), who may delegate these duties further to their trials team(s). All delegation of duties will be documented (e.g., using the CI declaration and/or the Clinical Trials Task Delegation Log (UoB-SPO-QCD-001)). CI: the CI may delegate some activities to members of their research team, although evidence of CI oversight and approval is still required. It is highlighted within this SOP where activities are, and are not, appropriate for

FAQs

What is the purpose of this SOP?

It describes data management procedures that must be followed for a clinical research project.

Which clinical research projects does the SOP cover?

It applies to UoB-sponsored studies, externally sponsored studies when consistent with UoB contracts, and studies approved by a UoB REC where UoB GCP principles are required.

How is the SOP implemented and what timing exceptions apply?

Implementation follows the document’s effective date, except specified procedural points that have a three-month implementation period.

Sep 2, 2026

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