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

 

Site set-up

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

 

Interim monitoring

MPD986 Trial Monitoring Visits
FRM4473 Interim Monitoring Visit Report

 

End of study

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

 

Safety reporting

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

 

Serious breaches

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

 

Additional documents

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


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