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 |