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 |
|
9.0 | Feb 2023 |
Trial Closure Road MapLink opens in a new window |
|
4.0 | Feb 2022 |
Comprehensive SOP Glossary |
|
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 |
|
ALL | |
RCP |
|
ALL | ||
H&S |
Health & Safety Policy and ResponsibilitiesLink opens in a new window |
|
ALL | |
WCTU RA |
WCTU Building - Risk AssessmentLink opens in a new window Version: 2.0 Effective Date: Dec 2023 |
|
ALL | |
1 |
Version: 4.0 Effective Date: Nov 2023 |
|
ALL | |
2 |
Research Applications and ContractsLink opens in a new window Version: 2.0 Effective Date: Jun 2022 |
|
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 |
|
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 |
|
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 Approvals Version: 5.0 Effective date: Feb 2024 Part 3 Communication with Approval BodiesLink opens in a new window Version: 2.0 Effective Date: Dec 2021 |
|
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 |
|
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 |
|
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 |
|
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 |
|
ALL | |
10 |
Insurance for Clinical Research StudiesLink opens in a new window Version: 2.0 Effective Date: Jun 2022 |
|
RA/F | Clinical Trial Insurance Specific Trial PolicyLink opens in a new window |
11 |
Version: 4.0 Effective Date: Nov 2023 |
|
ALL |
Link to TemplatesLink opens in a new window T08 ISF Index T14 PSF Index T26 TMF Index |
12 |
Version: 3.0 Effective Date: Oct 2023
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 |
|
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 |
|
P | The Template documents referred to in this SOP are available from the programming team on request. |
15(1) |
Version: 4.0 Effective Date: Mar 2022 |
|
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: 3.0 Effective Date: Mar 2022 |
|
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: 2.0 Effective Date: Feb 2023 |
|
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 |
|
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 |
Version: 3.0 Effective Date: August 2022 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:
Part 2:
Part 3:
Part 4:
|
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 |
18 |
Risk Assessment & MonitoringLink opens in a new window Version: 2.0 Effective Date: Jun 2022 |
|
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 |
|
RA/F, S, ST | |
20 |
Closing Research Study Recruitment SitesLink opens in a new window Version: 4.0 Effective Date: Oct 2023 |
|
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 |
|
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 |
Version: 3.0 Effective Date: Mar 2024 |
|
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 |
|
ALL | |
24 |
Essential Training and Training RecordsLink opens in a new window Version: 3.0 Effective Date: Oct 2023 |
|
ALL | |
25 |
Auditing of Clinical TrialsLink opens in a new window Version: 2.0 Effective Date: Apr 2022 |
|
DC | |
26 |
Clinical Research Study Activation, Site Selection and InitiationLink opens in a new window Version: 4.0 Effective Date: May 2023 |
|
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 |
Version: 3.0 Effective Date: Mar 2024 |
|
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 |
|
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 |
Version: 4.0 Effective Date: Jul 2023 |
|
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 |
|
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 |
|
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 |
|
RA/F, DC |
Link to TemplatesLink opens in a new window T39 Review Approval Working Instructions T65 Working Instruction Template |
35 |
Handling Requests for InformationLink opens in a new window Version: 2.0 Effective Date: March 2022 |
|
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 windowRed 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 |
|
ALL | |
37 |
Maintenance of the WCTU Information Asset RegisterLink opens in a new window Version: 2.0 Effective Date: Mar 2022 |
|
ALL |
Link to TemplatesLink opens in a new window G19 IAR Guidance |
38 |
Version: 2.0 Effective Date: Aug 2022 |
|
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 |
|
ALL | |
41 |
Blinding and Unblinding in Research StudiesLink opens in a new window Version: 2.0 Effective Date: Oct 2022 |
|
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 |
|
S, HE, P | |
43 |
Version: 2.0 Effective Date: Mar 2024 |
|
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 |
|
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 |
|
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) |