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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

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.
9.0 Feb 2023
Trial Closure Road MapLink 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.
4.0 Feb 2022
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.

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: 2.0

Effective Date: May 2022

  • 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: 2.0

Effective Date: Dec 2023

  • 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  
1

Preparation, Review and Approval of SOPs for UoW Sponsored and Co-Sponsored StudiesLink opens in a new window

Version: 4.0

Effective Date: Nov 2023

  • Biennial and proportionate review process for SOPs
  • Circulation of SOPs
ALL  
2

Research Applications and ContractsLink opens in a new window

Version: 2.0

Effective Date: Jun 2022

  • Content of a funding application
  • Research application process
  • Procedure for accepting research awards and contracts
RA/F, ST AcoRD online training module from NIHRLink opens in a new window
3

Research SponsorshipLink opens in a new window

Version: 4.0

Effective Date: Nov 2023

  • 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, ST

Link to TemplatesLink opens in a new window

T01 Division of Sponsor Responsibilities


Research & Impact Services webpageLink opens in a new window

4

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, ST

Link to TemplatesLink opens in a new window

T15 Protocol Non-CTIMP

T16 Protocol CTIMP

C04 Protocol Checklist

G02 Key Document Approval Guidance

T09 Key Document Approval Template


HRA Qualitative Protocol Guidance and TemplateLink opens in a new window

5

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

Version: 5.0

Effective Date: Feb 2023

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: 3.0

Effective Date: April 2024

  • Process to obtain REC/HRA approval
  • 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

 

 

 

RA/F

 

 

 

RA/F

Link to TemplatesLink opens in a new window

G23 Pharmacy Assurance

G24 Radiation Assurance

C10 EoT Notification Checklist

6

Amendments to Approved Study DocumentsLink opens in a new window

Version 6.0

Effective Date: Sept 2023

  • 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
7

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

G02 Key Document Approval Guidance

T09 Key Document Approval Template

G05 PPI Data Protection

G33 Email Approval Guidance

8

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, ST

Link to TemplatesLink opens in a new window

T21 Statistical Analysis Plan

T64 Statistics Approval Form

G30 Statistics Road Map

9

Randomisation in Research StudiesLink opens in a new window

Version: 3.0

Effective Date: Dec 2022

  • Definitions
  • Suitable methods of randomisation
  • The randomisation process
  • Checks to make pre-randomisation
ALL  
10

Insurance for Clinical Research StudiesLink opens in a new window

Version: 2.0

Effective Date: Jun 2022

  • Where to locate insurance information
  • Links to information about when referral may be required or additional premiums
RA/F Clinical Trial Insurance Specific Trial PolicyLink opens in a new window
11

Essential Documentation: Creation and Maintenance of Trial Master and Investigator Site FilesLink opens in a new window

Version: 4.0

Effective Date: Nov 2023

  • Definition of essential documents
  • Guidance on the content and control of the study master file (includes sponsor T/SMF and ISF)
ALL

Link to TemplatesLink opens in a new window

T08 ISF Index

T14 PSF Index

T26 TMF Index

12

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: 3.0

Effective Date: Oct 2023

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

Version 4.0

Effective Date: Oct 2023 

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

ALL

 

 

 


 

 

 

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


T37 TSC Charter

T38 DMC Charter

T45 Intro for PPI Reps

T60 TSC Agenda

T61 Confidentiality Statement for Observers

T62 DMC Members Insurance Letter


NIHR Guidance on Oversight CommitteesLink opens in a new window

13 SOP 13 Operation of a Data Monitoring Committee (DMC) is now obsolete and DMC responsibilities are covered in SOP 12 part 3
14

Clinical Trial Software DevelopmentLink opens in a new window

Version: 5.0

Effective Date: Dec 2022

  • Development workflow
  • Planning
  • Development
  • Testing
  • User acceptance
  • Support from the programming team
  • Reporting
P The Template documents referred to in this SOP are available from the programming team on request.
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

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

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

16

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

G02 Key Document Approval Guidance

T09 Key Document Approval Template

G33 Email Approval Guidance

G70 Data Items List

17

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

Version: 3.0

Effective Date: August 2022

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

Version: 3.0

Effective Date: August 2022

 

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

 

 

 

ALL

 

 

 

ALL

 

 

 

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

18

Risk Assessment & MonitoringLink opens in a new window

Version: 2.0

Effective Date: Jun 2022

  • 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


G02 Key Document Approval Guidance

T09 Key Document Approval Template

G33 Email Approval Guidance

19

Quality ControlLink opens in a new window

Version: 2.0

Effective Date: Sept 2022

  • 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, ST  
20

Closing Research Study Recruitment SitesLink opens in a new window

Version: 4.0

Effective Date: Oct 2023

  • 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

21

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, ST

Link to TemplatesLink opens in a new window

G02 Key Document Approval Guidance

T09 Key Document Approval Template

T21 SAP

22

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, ST

Link to TemplatesLink opens in a new window

T17 P&P Operating Procedures

G27 Data Sharing Statements

23

ArchivingLink opens in a new window

Version: 4.0

Effective Date: Oct 2023

  • 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  
24

Essential Training and Training RecordsLink opens in a new window

Version: 3.0

Effective Date: Oct 2023

  • 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  
25

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
DC  
26

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

Version: 4.0

Effective Date: May 2023

  • 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

C05 SIV Checklist

C09 Site Activation

G13 Site Training and Qualification Evidence

G14 SIV Guidance

G15 Site Delegation Log Review

G16 Source Data

27

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

28

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


EudraCT FAQs pageLink opens in a new window

AllTrials guidance on uploading results/amending recordsLink opens in a new window

29 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.
30 SOP 30 has been incorporated into SOP 15
31

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

Version: 4.0

Effective Date: Jul 2023

  • 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

32

Supplier Selection for Clinical Research StudiesLink opens in a new window

Version: 3.0

Effective Date: Nov 2023

  • 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

33

Economic Evaluation ConsiderationsLink opens in a new window

Version: 2.0

Effective Date: Apr 2022

  • 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

G02 Key Document Approval Guidance

T09 Key Document Approval Template

34

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

Version: 2.0

Effective Date: Sept 2022

  • 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


Document management on Q-PulseLink opens in a new window

35

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 informationLink opens in a new window

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

36

Data Breach Incident Management ProcedureLink opens in a new window

Version: 3.0

Effective Date: Jun 2022

  • Types of incident
  • Forming and investigation team
  • Assessment and reporting of incidents
ALL  
37

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

38

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

Version: 2.0

Effective Date: Aug 2022

  • 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  
39

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

40

WCTU Business Continuity PlanLink opens in a new window

Version: 2.0

Effective date: Jan 2023

  • 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  
41

Blinding and Unblinding in Research StudiesLink opens in a new window

Version: 2.0

Effective Date: Oct 2022

  • Allocation concealment
  • Blinding
  • Unblinding – emergency and prior to analysis
ALL

Link to TemplatesLink opens in a new window

T42 Unblinding Request Form

T43 Statistician Unblinding Form

T44 Unblinding Log

42

Clinical Data Management System (CDMS) Planning & MaintenanceLink opens in a new window  

Version: 2.0

Effective Date: Mar 2023

  • CDMS considerations and processes for planning, setup, and study completion
  • Sprints and User Acceptance Testing
  • System Support including Bugs, Data Cleaning, and User Access
  • Reporting
S, HE, P  
43

Seeking and Maintaining Approval from the Confidentiality Advisory Committee (CAG)Link opens in a new window

Version: 2.0

Effective Date: Mar 2024

  • How to make an application to CAG and when it is required
  • Who to involve in your application
  • How to maintain the approval so that is compliant with CAG terms
  • Training requirements
ALL

Link to TemplatesLink opens in a new window

G31 CAG Application Crib sheet

44

NHS England: Applications, Receipt of Data & Compliance Link opens in a new window

Version: 2.0

Effective Date: Mar 2024

  • How to apply for data from NHS Digital
  • Who to involve in your application
  • How to make sure you are compliant with the terms
  • Training requirements
ALL

Link to TemplatesLink opens in a new window

G32 NHS Digital Application Crib sheet

45

Document ManagementLink opens in a new window

Version: 1.0

Effective date: Dec 2022

  • Use of templates to create key documents
  • Version Control
  • Naming convention
  • Review and approval process
ALL

Link to TemplatesLink opens in a new window

G33 Email Approval Guidance

Key: All Staff (ALL), Research Associate (RA), Research Fellow (RF), Statistician (S), Health Economist (HE), Data Clerk (DC), Programmer (P), STARS Team (ST)