Standard Operating Procedures

All University of Warwick staff may access the Standard Operating Procedures (SOPs) and associated documents which have been developed by the Clinical Trials Unit. These are applicable to all University staff undertaking clinical research activity.

Contact WCTUQA@warwick.ac.uk if you have any feedback.

CLICK HERE TO GO DIRECTLY TO GUIDANCE AND TEMPLATESLink opens in a new window

Changes to terminology and definitions in line with new clinical trial regulations

The new clinical trial regulations are updating some terminology and introducing some new definitions. Our SOPs will be updated with these changes during their biennial reviews. Any key changes required to SOPs will be updated by the implementation date in April. Awareness will be raised with staff of these terminology updates through various communication methods along with requesting staff completion of updated GCP training. For an overview of the changes please visit the HRA websiteLink opens in a new window.

Table containing the checklist for setup, management and closedown of clinical trials; the trial closure roadmap; a comprehensive SOP glossary document.
Document Name	Description	Version	Effective Date
Trial Setup, Management, and Closedown Checklist	A checklist to support the setup, management and closedown of a clinical trial or study. Document contains the tasks involved, those who are responsible for completion of these tasks, and related SOPs.	10.0	Mar 2025
Trial Closure RoadmapLink opens in a new window	This document provides an overview of the processes and the order they should be completed during the closedown of a clinical trial or study. This includes those who have responsibility for each process, along with any supporting SOPs or documents.	6.0	Dec 2024
Comprehensive SOP Glossary	The Glossary is designed to support staff who are new to clinical trials, and those who are experienced, due to the large number of acronyms used.	3.0	May 2023

Templates, Checklists, and Guidance: The following link will take you to the WCTU templates, checklists and guidanceLink opens in a new window web page. In the final column of the table below you will find document references relevant to each SOP to aid in locating these documents on the aforementioned web page.

Table containing a list of the University of Warwick SOPs related to clinical research conducted on behalf of the University of Warwick. In addition each SOP has a description of the contents and there are links to related templates, guidance, and checklists along with links to relevant external guidance.

SOP

TITLE

What is covered in this SOP?

Applicable to:

Required to read all SOPs:

CTU Director, Head and Deputy Head of Operations, SPMs, TM/TCs, CIs, and QA team.

Document References for related Templates, Checklists, and Guidance

External Guidance

CDS

Clear Desk and Screen PolicyLink opens in a new window

Version: 3.0

Effective Date: June 2024

Requirements for WCTU colleagues to have a clear desk and screen
Process for oversight of compliance with policy

ALL

RCP

Research Code of PracticeLink opens in a new window

The University of Warwick's guiding principles and standards of good practice in research across all subject disciplines and fields of study in the University

ALL

H&S

Health & Safety Policy and ResponsibilitiesLink opens in a new window

The University of Warwick's Health & Safety Policy
The Leadership & Management of Health & Safety at the UoW document contains requirements for staff to fulfil their responsibilities in relation to health and safety (staff only need to read the sections of this document relevant to their role)

ALL

WCTU RA

WCTU Building - Risk AssessmentLink opens in a new window

Version: 3.0

Effective Date: Nov 2024

Risk assessment for working in the WCTU building
WCTU staff should review the building risk assessment to ensure they are aware of any risks and their responsibilities in relation to these risks

ALL

SOP Development and Approval for Warwick-Sponsored StudiesLink opens in a new window

Version: 5.0

Effective Date: Dec 2025

Biennial and proportionate review process for SOPs
Circulation of SOPs

ALL

Research Applications and ContractsLink opens in a new window

Version: 3.0

Effective Date: Jun 2025

Content of a funding application
Research application process
Procedure for accepting research awards and contracts
Studies involving NHS Trusts
Due diligence undertaken by R&IS

RA/F

NOI Form - Clinical TrialsLink opens in a new window

NOI Form - Other ResearchLink opens in a new window

AcoRD online training module from NIHRLink opens in a new window

Research SponsorshipLink opens in a new window

Version: 5.0

Effective Date: Dec 2025

Requirement for sponsorship
How to apply for University of Warwick sponsorship
Intention to sponsor/sponsorship in principle for grant applications
Sponsorship arrangements when CI leaves University of Warwick

RA/F

Research & Impact Services webpageLink opens in a new window

Trial/Research Study ProtocolLink opens in a new window

Version: 4.0

Effective Date: Mar 2024

Generation, review and approval of a research protocol
Content of a research protocol

RA/F, S, HE

Link to TemplatesLink opens in a new window

T15 Protocol Non-CTIMP

T16 Protocol CTIMP

C04 Protocol Checklist

T09 Key Document Approval Template

G37 Patient Accessibility

HRA Qualitative Protocol Guidance and TemplateLink opens in a new window

Part 1 Gaining Initial Ethical Approval for Research StudiesLink opens in a new window

Version: 6.0

Effective Date: Apr 2025

Part 2 Gaining Initial Regulatory ApprovalsLink opens in a new window

Version: 5.0

Effective date: Feb 2024

Part 3 Communication with Approval BodiesLink opens in a new window

Version: 5.0

Effective Date: Mar 2025

Process to obtain REC/HRA approval
IRAS submission
Determining whether a CTA is required
Applying for a EudraCT number and a Clinical Trial Authorisation (CTA)
Temporary halts
Annual reports
Developmental Safety Update Reports (DSURs) /CESP
Suspension and termination of clinical trials
Declaration of end of trial and summary reports

RA/F

Link to TemplatesLink opens in a new window

G23 Pharmacy Assurance

G24 Radiation Assurance

C10 EoT Notification Checklist

HRA Toolkit to support research carried out across borders in the UKLink opens in a new window

Amendments to Approved Study DocumentsLink opens in a new window

Version 7.0

Effective Date: Dec 2025

Process for making amendments to approved documents
Amendment submissions to REC/HRA and MHRA
Amendments - inc. funder permissions
Substantial/non-substantial amendments

RA/F

Diagram of 35 day implementation period for devolved nationsLink opens in a new window

HRA Template Amendment History LogLink opens in a new window

Participant Information and ConsentLink opens in a new window

Version: 3.0

Effective Date: Mar 2024

Why consent is required
Generation, review and approval of Participant Information and Consent
Obtaining consent in different populations and scenarios
GDPR transparency requirements for the PIS
Withdrawal of consent
Information for participants at the end of study

ALL

Link to TemplatesLink opens in a new window

C01 ICF Checklist

C03 PIS Checklist

T09 Key Document Approval Template

G05 PPI Data Protection

G33 Email Approval Guidance

G37 Patient Accessibility

Statistical ConsiderationsLink opens in a new window

Version: 3.0

Effective Date: Feb 2024

Statistical input into planning the study and development of the protocol
Input into the Statistical Analysis Plan (SAP)
Data validation and programming/code checks
Interim and final analyses
Statistics Approval Form

RA/F, S

Link to TemplatesLink opens in a new window

T21 Statistical Analysis Plan

T64 Statistics Approval Form

G30 Statistics Road Map

C13 Statistical Processes

Randomisation in Research StudiesLink opens in a new window

Version: 4.0

Effective Date: Mar 2025

Definitions
Suitable methods of randomisation
The randomisation process
Checks to make pre-randomisation

ALL

Insurance for Clinical Research StudiesLink opens in a new window

Version: 5.0

Effective Date: Aug 2025

Where to locate insurance information
Links to information about when referral may be required or additional premiums

RA/F

Clinical Trial Insurance Specific Trial Policy

Essential RecordsLink opens in a new window

Version: 5.0

Effective Date: Dec 2025

Definition of essential records
Guidance on the content and control of the study master file (includes sponsor T/SMF, ISF, and Pharmacy File)

ALL

Link to TemplatesLink opens in a new window

T08 ISF Index

T14 PSF Index

T26 TMF Index

T73 International TMF Index

G40 Resource Account

GCP Defined Responsibilities Part 1: Trial/Study Management Group and day-to-day activitiesLink opens in a new window

Version: 4.0

Effective Date: Jun 2024

GCP Defined Responsibilities Part 2: Trial/Study Steering CommitteeLink opens in a new window

Version: 4.0

Effective Date: Nov 2025

GCP defined responsibilities Part 3: Data Monitoring CommitteeLink opens in a new window

Version 5.0

Effective Date: Nov 2025

Defines role types and associated responsibilities for a study TMG & day-to-day activities
Procedures for change or loss of study CI or PI
Defines roles and purpose of oversight committees (inc. template charters)
Reporting structures for oversight committees

ALL

Link to TemplatesLink opens in a new window

T23 Coordinating Centre Del. Log

T27 TMG Charter

T28 TMG Agenda

T29 Decision & Action Log

T30 UoW Style Agenda

T31 UoW Style Minutes

T36 TM/TC Handover Guidance

CI Short Term Absence GuidanceLink opens in a new window

T37 TSC Charter

T38 DMC Charter

T45 Intro for PPI Reps

T46 Data Snapshot/Lock Form

T60 TSC Agenda

T61 Confidentiality Statement for Observers

T62 DMC Members Insurance Letter

NIHR Guidance on Oversight CommitteesLink opens in a new window

SOP 13 Operation of a Data Monitoring Committee (DMC) is now obsolete and DMC responsibilities are covered in SOP 12 part 3

Clinical Trial Software DevelopmentLink opens in a new window

Version: 6.0

Effective Date: Apr 2025

Development workflow
Planning
Development
Testing
User acceptance
Support from the programming team
Reporting

The Template documents referred to in this SOP are available from the programming team on request.

Link to TemplatesLink opens in a new window

T75 EDC Validation Plan

15(1)

Information Handling: Part 1: Security, Protection and Management of Data for Clinical ResearchLink opens in a new window

Version: 5.0

Effective Date: Apr 2024

Data Flow Maps and associated data protection procedures
Defining Data Items
Generation review and approval of DMP
Training
Data collection, receipt, tracking and entry of data
Queries (inc. resolution)

ALL

Link to TemplatesLink opens in a new window

T41 DFM Builder

T75 EDC Validation Plan

G33 Email Approval Guidance

G01 DCF Guidance

G69 DMP Template

G70 Data Items List

G08 Sensitive Calls Flowchart

G09 Sensitive Calls Guidance

G10 Sensitive Calls Tips

G11 Participant Voicemail

G12 Core Outcome Phone calls

G37 Patient Accessibility

G43 Data Entry Guidelines

15(2)

SOP 15 part 2 Electronic Security has been incorporated into SOP 15 part 1

15(3)

Part 3: Sharing DataLink opens in a new window

Version: 4.0

Effective Date: May 2024

Checks to enable safe sharing
Data classification
Safe transfer
Data Sharing & Data Processing Agreements

ALL

Link to TemplatesLink opens in a new window

T04 Data Sharing Green Light

15(4)

Part 4: Extraction of Data for Analysis and Data LockLink opens in a new window

Version: 3.0

Effective Date: Apr 2024

Extracting and saving data outputs
Data freeze, snapshot and lock
Process for recording a snapshot or lock
Process for requesting unlock

ALL

Link to TemplatesLink opens in a new window

T46 Confirmation of Snapshot/lock Form

T47 Request to Unlock Form

C13 Statistical Processes

Case Report Forms (CRF)Link opens in a new window

Version: 4.0

Effective Date: Mar 2024

Generation, review and approval of the CRF
Amendments to the design
\Defining data items
CRF annotation

ALL

Link to TemplatesLink opens in a new window

T09 Key Document Approval Template

T70 Data Items List

G33 Email Approval Guidance

G37 Patient Accessibility

G39 Questionnaires

G43 Data Entry Guidelines

Part 1: Pharmacovigilance for Clinical Trials of Investigational Medicinal Products (CTIMPS)Link opens in a new window

Version: 4.0

Effective Date: Nov 2024

Part 2: Safety Reporting for Clinical Trials other than those of Investigational Medicinal ProductsLink opens in a new window

Version: 4.0

Effective Date: Nov 2024

Part 3: Urgent Safety MeasuresLink opens in a new window

Version: 4.0

Effective Date: Dec 2023

Part 4: Reference Safety InformationLink opens in a new window

Version: 3.0

Effective Date: Dec 2023

Part 1:

Safety Reporting process and timelines for CTIMPs
Monitoring the safety profile

Part 2:

Safety Reporting process and timelines for non-CTIMPs
Monitoring the safety profile

Part 3:

Identification and implementation of Urgent Safety Measures
Parties to notify and timelines for USMs

Part 4:

Selecting, defining and approving RSI
Using RSI to assess expectedness of SARs in CTIMPs
Updates/changes to RSI and how to manage them

ALL

Link to TemplatesLink opens in a new window

T05 DSUR Template

T51 - T57 SAE Templates

T63 RSI Implementation Log

User Reference Guide - Individual Case Safety Report (ICSRs) SubmissionsLink opens in a new window

FAQ - ICSR SubmissionsLink opens in a new window

Risk Assessment & MonitoringLink opens in a new window

Version: 3.0

Effective Date: Sept 2024

Generation, review and approval of Risk Assessments and Monitoring Plans
Data Protection Impact Assessments (DPIAs)
Planned and triggered monitoring visits, reports, findings and their resolution

RA/F, S, HE

Link to TemplatesLink opens in a new window

T19 RAMP Template - for a copy contact QA Team

T58 Trial Monitoring Checklist

T10 Home Visit RA

T11 Lone Worker RA

T12 Lone Worker Visit Details

WMS Lone Working GuidanceLink opens in a new window

HSS Lone Working GuidanceLink opens in a new window

G16 Source Data

T25 Source Data Location Log

T09 Key Document Approval Template

G33 Email Approval Guidance

Quality ControlLink opens in a new window

Version: 3.0

Effective Date: Dec 2024

Cross checking of essential documents by the QA team
Quality control of accumulating data
Quality control of data entry (data checking)
Quality control of intervention delivery
Quality control of IMP
Quality control of final study results

RA/F, S

Closing Research Study Recruitment SitesLink opens in a new window

Version: 5.0

Effective Date: Feb 2026

Closing an investigator site (inc. early closure)
Template letters and checklists

S, RT

Link to TemplatesLink opens in a new window

T33 Site Closure Checklist

T34 Site Closure Letter

G38 Data Transfer to Sites

T76 Template email for site data transfer (Non-CTIMP)

T77 Template email for site data transfer (CTIMP)

T78 Study Closure Plan

Statistical Analysis PlanLink opens in a new window

Version: 3.0

Effective Date: Oct 2023

Generation, review and approval of the SAP
Template contents

RA/F, S

Link to TemplatesLink opens in a new window

T09 Key Document Approval Template

T21 SAP

C13 Statistical Processes

Publication and DisseminationLink opens in a new window

Version: 3.0

Effective Date: Mar 2024

Generation, review and approval of publications
Study reports and presentation of findings for funders, participants and collaborators
Considerations for journal publication
Sharing and dissemination

RA/F, S, HE

Link to TemplatesLink opens in a new window

T17 P&P Operating Procedures

G27 Data Sharing Statements

G37 Patient Accessibility

Archiving

Version: 5.0

Effective Date: Nov 2025

Preparation and transfer to the archive for paper and electronic documents
Maintenance and review of archived documents
Retrieval and control of access to archive
Destruction of archived documents

ALL

Essential Training and Training RecordsLink opens in a new window

Version: 4.0

Effective Date: Feb 2026

Content of a training record
Essential training requirements
Required reading incl. SOPs
Provisions for temporary and honorary staff
Retention of training records for staff leaving WCTU

ALL

Auditing of Clinical TrialsLink opens in a new window

Version: 3.0

Effective Date: Apr 2024

Types of audit and remit
Notification and reporting of findings (inc. classification)
Responding to audit findings
Escalation of overdue findings

Clinical Research Study Activation, Site Selection and InitiationLink opens in a new window

Version: 5.0

Effective Date: July 2025

Activation of a clinical research study (Sponsor green light for study to commence)
Selection of sites
Set-up, site initiation and activation of sites

Link to TemplatesLink opens in a new window

T18 Green Light RCT Activation

T22 Site Delegation Log

T23 Coordinating Centre Del. Log

T25 Source Data Location Log

T50 Site Initiation Report Letter

T71 Site Feasibility Questionnaire

T72 International Head of Terms

T74 Green Light RCT Activation for ICC

C05 SIV Checklist

C09 Site Activation

C12 International Site Activation

G13 Site Training and Qualification Evidence

G14 SIV Guidance

G15 Site Delegation Log Review

G16 Source Data

G36 International Collaboration on Clinical Trials

Management of Investigational Medicinal Products (IMPs) for Clinical TrialsLink opens in a new window

Version: 3.0

Effective Date: Mar 2024

IMP supply considerations
Labelling of IMP
Drug accountability
Storage and transfer of IMP

RA/F

Link to TemplatesLink opens in a new window

T06 IMP Accountability Log

T07 IMP Prescription

Transparency in Clinical Research StudiesLink opens in a new window

Version: 4.0

Effective Date: Oct 2023

Registration of studies
Making results public
Letting participants know about results
Making data available for future research

ALL

Link to TemplatesLink opens in a new window

G27 Data Sharing Statements

G37 Patient Accessibility

EudraCT FAQs pageLink opens in a new window

SOP 29 (Gaining NHS Trust R&D Approval) is no longer required due to changes to the NHS permissions system. See SOP 6 for details.

SOP 30 has been incorporated into SOP 15

Handling non-compliances, research misconduct and serious breaches of GCP and/or Study ProtocolLink opens in a new window

Version: 5.0

Effective Date: Aug 2025

Definitions of deviations, violations and serious breaches - who to involve and the timelines for each
Contents of a CAPA
Guidance on forming an investigation team in the event of a potential serious breach

ALL

Link to TemplatesLink opens in a new window

G04 Serious Breach Investigation Team

T13 CAPA Report Form

G29 Non-Compliance reporting for UHCW Sponsored Studies

G25 Non-Compliance Log Working Instruction

MHRA: Report a Serious Breach pageLink opens in a new window

Service Provider Selection and Oversight for Clinical Research StudiesLink opens in a new window

Version: 4.0

Effective Date: Dec 2025

Identifying the need for a product or service
Identification and evaluation of potential providers – inc. Finregs and information security considerations
Contracting
Conflict of interest
Oversight of vendors/suppliers

RA/F

Link to TemplatesLink opens in a new window

T59 Vendor Questionnaire

Health Economic Evaluation ConsiderationsLink opens in a new window

Version: 3.0

Effective Date: Jul 2024

Planning and preparation for HE content of a study
Data collection and monitoring
Health Economic Analysis Plan
Analysis of HE data (inc. missing data)
Publication

RA/F, S, HE

Link to TemplatesLink opens in a new window

T09 Key Document Approval Template

Generation, Review and Approval of Trial Specific Working InstructionsLink opens in a new window

Version: 3.0

Effective Date: Dec 2024

Who should review and approve working instructions
How should amendments be handled

RA/F, DC

Link to TemplatesLink opens in a new window

T39 Review Approval Working Instructions

T65 Working Instruction Template

G43 Data Entry Guidelines

Handling Requests for InformationLink opens in a new window

Version: 3.0

Effective Date: May 2024

Dealing with requests for information from participants or members of the public
Dealing with the press
Dealing with Freedom of Information (FOI) and Data Protection Act (DPA) requests

ALL

Link to TemplatesLink opens in a new window

T02 Communications Plan

G08 Sensitive Calls Flowchart

G09 Sensitive Calls Guidance

G10 Sensitive Calls Tips

List of clinical staff available to assist with requests for information

Red Flag card for phone call supportLink opens in a new window

Data Breach Incident Management ProcedureLink opens in a new window

Version: 4.0

Effective Date: Jul 2024

Types of incident
Forming and investigation team
Assessment and reporting of incidents

ALL

Maintenance of the WCTU Record of Processing Activities & Information Asset RegisterLink opens in a new window

Version: 3.0

Effective Date: May 2024

Adding new assets to the register
Reviewing and updating the asset register (inc who is responsible)
Recording and oversight of data sharing activity via the register

ALL

Link to TemplatesLink opens in a new window

G19 IAR Guidance

Research Passports, Letters of Access (LOA) and Honorary Research Contracts (HRCs)Link opens in a new window

Version: 3.0

Effective Date: Oct 2024

Procedures to identify where a research passport may be required in order to obtain a Letter of Access (LOA) or an Honorary Research Contract (HRC)
How to apply
How to maintain a valid Research Passport

RA/F

SOP 39 WCTU Vulnerability and Penetration Testing Procedure has been incorporated into SOP 14

WCTU Business Continuity PlanLink opens in a new window

Version: 3.0

Effective date: Dec 2025

Process for response to an incident that could disrupt normal service/activities in WCTU
Continuity team procedures
Requirement for project teams to identify priority activities

ALL

Blinding and Unblinding in Research StudiesLink opens in a new window

Version: 3.0

Effective Date: Dec 2024