Clinical Trial Set-Up
Clinical Trial Set-Up
We will work with you to set up clinical trials and studies:
- turning a proposal for funding into a full protocol
- developing consent forms and patient information sheets (PIS)
- feasibility
- risk assessments
- development of data capture forms and systems
- programming/set up of trial databases
- development and implementation of randomisation strategy
- acquisition of questionnaires
- development of trial-specific manuals of procedures and standard operating procedures (SOPs)
- development of trial-specific documentation (e.g. delegation logs, monitoring plans, data management plans)
- set-up of supporting departments and documentation required (e.g. Laboratory Manual, delegation logs)
- application for NIHR portfolio adoption
- application to MHRA, HRA/HCRW and Research Ethics Committee (REC)
- registering study with EUDRACT
- completing IRAS to apply for permissions and approvals
- registration of the trial on a publicly accessible database/register (e.g. ISRCTN)
- applications for other permissions and approvals as required
- set-up of Trial Master File (TMF)
- set-up of Investigator Site Files (ISF)
- liaison with trial sites, including international sites
- investigator meetings and site initiation
- Contract/agreement negotiation and approvals
- establish trial oversight committees (e.g. TSC, IDMC, TMG)
- training trial personnel
- green lighting of trial sites