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.

Grant application and trial set-up

We can support the researcher at the trial set-up phase by:

Assisting with the Grant application - whether outline or full applications
Identifying an appropriate funding stream

We offer statistical support, for example:

Sample size calculations
Methodology advice
Advice on appropriate outcome measures
Generation of randomisation sequence

We can also support the researcher by:

Setting the budget and timeline
Feasibility and site selection activity
Protocol preparation
Patient information and consent form writing
Designing data capture forms and guidelines
MACRO database design
Writing study specific procedures/SOPs
Preparing the study handbook for site staff
Ethics and regulatory submissions
Obtaining NIHR portfolio adoption
Obtaining R&D permissions from each site
Data Monitoring Committee and Trial Steering Committee set-up
Organising Investigator Meetings
Conducting site initiation visits
IMP management
Setting up trial master file
Registration of trial on a publicly accessible website
Setting up a trial website
Setting up a randomisation service

Recruitment phase

We can support the researcher at the recruitment phase with the following

Site oversight, motivation and monitoring (on site and remote)
Site support, including recruitment strategies
Preparation and dissemination of newsletters
Maintenance of trial website
Adverse event management
Data Management
- Data entry
- Generation of data queries
- Screening log management
Statistical services
- Interim analyses as required
Provision of unblinded data for Data Monitoring Committee (DMC) reports
- Input into other reports as required
Assist with preparation and submission of interim reports to:
- Sponsor
- R&D departments
- Ethics committee
- Regulatory authorities
Organisation of Trial Steering Committee (TSC) and DMC meetings

Close down and analysis

Once recruitment is complete, we can support the investigator with the following activities:

Prompt resolution of outstanding data queries
Data cleaning
Database Quality Assurance activities
Statistical analysis and interpretation of results
Report writing for funders, sponsors, ethics committee and regulatory authorities
Close down of sites
Archiving of trial documentation

Dissemination of results

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. Click on the relevant sections to see the forms and procedure documents available.

Site selection

Site set-up

Interim monitoring

End of study

Safety reporting

Serious breaches

Additional procedures

MPD1180 - CTU-Preparation of Patient Information
MPD983 - Informed Consent Procedure
MPD980 - Protocol development
MPD1124 - CTU responsibilities and procedures for maintaining the Trial Master File
MPD928 - CTU Randomisation, Blinding and Code Break Procedures
MPD1093 - CTU-IMP Management and Accountability
MPD1072 - CTU-Regulatory Release of Investigational medicinal product
MPD979 - CTU Trial Management Plan
MPD1125 - CTU Risk Assessment of Clinical trials
MPD981 - Research Ethics Application and Approval
MPD982 - CTU -Gaining Regulatory Approvals
MPD1185 - CTU- Clinical Trial Contract management including financial disclosure
MPD991 - CRF Development
MPD993 - Database development and testing
MPD996 - Post-Go-Live Database change control
MPD1178 - MACRO User training and Support
MPD995 - Data checking and query process
MPD997 - Database final QC and lock procedures
MPD1177 - CTU-Data Handling, Transfer and Security
MPD998 - Statistical Analysis and Reporting
DAT2708 - CTU Document Naming Conventions and version control guidelines
DAT2291 - Metadata completion Guidelines
DAT2865 - CTU Controlled documents training Matrix

Additional forms

FRM4679 - Protocol tracking form
FRM4894 - CTU CTIMP Protocol template
FRM5015 - CTU Pharmacy File Index
FRM5034 - CTU Trial Site File Index
FRM4480 - CTU TMF List of Contents
FRM5225 - Randomisation Specification Form
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
FRM5228 - CTU- Trial Level Green Light form
FRM5229 - CTU-Site level Green Light Form
FRM4474 - TMG Charter Template
FRM4475 - TSC Charter template
FRM4736 - TSC Report Template
FRM4476 - DMC Charter template
FRM4737 - DMC Report Template
FRM4470 - CTU Risk Assessment Template
FRM5149 - CTU Trial Monitoring Plan
FRM4478 - Principal Investigator Statement
FRM4489 - CRF Transmittal Form
FRM4490 - CRF approval form
FRM4491 - Database Project specification template
FRM4494 - Metadata template
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
FRM4727 - Data Management Plan
FRM4834 - Database Closure - Data Manager Checklist
FRM4816 - Final Database Lock
FRM4835 - Final QC report
FRM4817 - Database Unlock/re-lock
FRM4828 - Statistical master file content list
FRM4827 - Statistician trial checklist
FRM4672 - Data Analysis Report
FRM4671 - Statistical Analysis Plan

Support we provide

Procedures and forms

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