Hi there, we see you're using OS, why not try our app?
Download

Support we provide

We support researchers through the different stages of the clinical trial journey, from the initial idea to the dissemination of results. Please click below for more information.

To see a diagram of the life cycle of a clinical trial, click here

Procedures and forms

We have a suite of procedures and forms available on the NHS Blood and Transplant (NHSBT) controlled document system which are used to ensure good clinical practice and regulatory compliance in the conduct of the clinical trials, and consistency of working across trials. NHSBT employees may access these documents via the controlled document library. Collaborators from outside NHSBT may request copies of any of our procedures or forms by emailing CTU@nhsbt.nhs.uk with their request.

Site selection

MPD988
Site Selection
Site Selection
FRM4477
Site Selection
Site assessment questionnaire template
FRM4536
Site Selection
Trial Synopsis Template
FRM4888
Site Selection
Site Assessment Visit report
DAT2203
Site Selection
Investigator responsibilities

 

Site set-up

MPD989
Clinical Study Site Set-Up Procedures
Clinical Study Site Set-Up Procedures
DAT2204
Clinical Study Site Set-Up Procedures
Essential Documents Before trial Starts
FRM4479
Clinical Study Site Set-Up Procedures
SIV report
FRM5456
Clinical Study Site Set-Up Procedures
Site Authorisation to recruit form (non- CTIMP studies)

 

Interim monitoring

MPD986
Trial Monitoring Visits
Trial Monitoring Visits
FRM4473
Trial Monitoring Visits
Interim Monitoring Visit Report

 

End of study

MPD990
End of Study Procedures
End of Study Procedures
FRM4486
End of Study Procedures
Site Close-Out Visit report
FRM4487
End of Study Procedures
Site self-assessment Close-out form
FRM4488
End of Study Procedures
End of Study Report template

 

Safety reporting

MPD984
Safety Reporting in Clinical trials of Blood Components
Safety Reporting in Clinical trials of Blood Components
MPD1098
Safety Reporting in Clinical trials of Blood Components
CTU - Safety reporting/pharmacovigilance in clinical trials of investigational medicinal products and Urgent Safety Measures
FRM5439
Safety Reporting in Clinical trials of Blood Components
DSUR Template

 

Serious breaches

MPD985
Serious Breaches of Good Clinical practice or the Protocol in Clinical trials
Serious Breaches of Good Clinical practice or the Protocol in Clinical trials
FRM4471
Serious Breaches of Good Clinical practice or the Protocol in Clinical trials
Serious Breach Report Form

 

Additional documents

MPD1180
CTU-Preparation of Patient Information
CTU-Preparation of Patient Information
MPD983
CTU-Preparation of Patient Information
Informed Consent Procedure
MPD980
CTU-Preparation of Patient Information
Protocol development
FRM4679
CTU-Preparation of Patient Information
Protocol tracking form
FRM4894
CTU-Preparation of Patient Information
CTU CTIMP Protocol template
MPD1124
CTU-Preparation of Patient Information
CTU responsibilities and procedures for maintaining the Trial Master File
FRM5015
CTU-Preparation of Patient Information
CTU Pharmacy File Index
FRM5034
CTU-Preparation of Patient Information
CTU Trial Site File Index
FRM4480
CTU-Preparation of Patient Information
CTU TMF List of Contents
MPD928
CTU-Preparation of Patient Information
CTU Randomisation, Blinding and Code Break Procedures
FRM5225
CTU-Preparation of Patient Information
Randomisation Specification Form
MPD1093
CTU-Preparation of Patient Information
CTU-IMP Management and Accountability
FRM5144
CTU-Preparation of Patient Information
CTU IMP Recall form
FRM5146
CTU-Preparation of Patient Information
CTU Drug Accountability Log
FRM5150
CTU-Preparation of Patient Information
CTU Drug Destruction Log
FRM5147
CTU-Preparation of Patient Information
CTU IMP Handling Manual
FRM5148
CTU-Preparation of Patient Information
CTU IMP Temperature Deviations
FRM5145
CTU-Preparation of Patient Information
CTU IMP Tracker
FRM5143
CTU-Preparation of Patient Information
CTU Prescription
MPD1072
CTU-Preparation of Patient Information
CTU-Regulatory Release of Investigational medicinal product
FRM5228
CTU-Preparation of Patient Information
CTU- Trial Level Green Light form
FRM5229
CTU-Preparation of Patient Information
CTU-Site level Green Light Form
MPD979
CTU-Preparation of Patient Information
CTU Trial Management Plan
FRM4474
CTU-Preparation of Patient Information
TMG Charter Template
FRM4475
CTU-Preparation of Patient Information
TSC Charter template
FRM4736
CTU-Preparation of Patient Information
TSC Report Template
FRM4476
CTU-Preparation of Patient Information
DMC Charter template
FRM4737
CTU-Preparation of Patient Information
DMC Report Template
DAT2708
CTU-Preparation of Patient Information
CTU Document Naming Conventions and version control guidelines
MPD1125
CTU-Preparation of Patient Information
CTU Risk Assessment of Clinical trials
FRM4470
CTU-Preparation of Patient Information
CTU Risk Assessment Template
FRM5149
CTU-Preparation of Patient Information
CTU Trial Monitoring Plan
MPD981
CTU-Preparation of Patient Information
Research Ethics Application and Approval
MPD982
CTU-Preparation of Patient Information
CTU -Gaining Regulatory Approvals
FRM4478
CTU-Preparation of Patient Information
Principal Investigator Statement
MPD1185
CTU-Preparation of Patient Information
CTU- Clinical Trial Contract management including financial disclosure
MPD991
CTU-Preparation of Patient Information
CRF Development
FRM4489
CTU-Preparation of Patient Information
CRF Transmittal Form
FRM4490
CTU-Preparation of Patient Information
CRF approval form
MPD993
CTU-Preparation of Patient Information
Database development and testing
FRM4491
CTU-Preparation of Patient Information
Database Project specification template
FRM4494
CTU-Preparation of Patient Information
Metadata template
DAT2291
CTU-Preparation of Patient Information
Metadata completion Guidelines
FRM4493
CTU-Preparation of Patient Information
Requirements and functional specification
FRM4731
CTU-Preparation of Patient Information
Database test plan
FRM4732
CTU-Preparation of Patient Information
Unit and system test conditions
FRM4492
CTU-Preparation of Patient Information
User acceptance test conditions
FRM4495
CTU-Preparation of Patient Information
Test scripts template
FRM4733
CTU-Preparation of Patient Information
Database validation report
FRM4734
CTU-Preparation of Patient Information
Database implementation Plan
FRM4735
CTU-Preparation of Patient Information
Site Code Authorisation
FRM4496
CTU-Preparation of Patient Information
Database version control
FRM4497
CTU-Preparation of Patient Information
Database delegation log
FRM4846
CTU-Preparation of Patient Information
Data Management Study File Index
MPD996
CTU-Preparation of Patient Information
Post-Go-Live Database change control
MPD1178
CTU-Preparation of Patient Information
MACRO User training and Support
MPD995
CTU-Preparation of Patient Information
Data checking and query process
FRM4727
CTU-Preparation of Patient Information
Data Management Plan
MPD997
CTU-Preparation of Patient Information
Database final QC and lock procedures
FRM4834
CTU-Preparation of Patient Information
Database Closure - Data Manager Checklist
FRM4816
CTU-Preparation of Patient Information
Final Database Lock
FRM4835
CTU-Preparation of Patient Information
Final QC report
FRM4817
CTU-Preparation of Patient Information
Database Unlock/re-lock
MPD1177
CTU-Preparation of Patient Information
CTU-Data Handling, Transfer and Security
MPD998
CTU-Preparation of Patient Information
Statistical Analysis and Reporting
FRM4828
CTU-Preparation of Patient Information
Statistical master file content list
FRM4827
CTU-Preparation of Patient Information
Statistician trial checklist
FRM4672
CTU-Preparation of Patient Information
Data Analysis Report
FRM4671
CTU-Preparation of Patient Information
Statistical Analysis Plan
DAT2865
CTU-Preparation of Patient Information
CTU Controlled documents training Matrix


You may also be interested in