Clinical Trial, conduct, management & monitoring
Clinical Trials Conduct, Management and Monitoring
We conduct high quality trials and studies, through management and monitoring:
- amendment preparation and approvals
- patient recruitment and retention, including design of
- recruitment and retention strategies
- informed consent procedures
- ongoing communication with trial sites and investigators
- preparation of trial newsletters
- risk assessment review
- set-up and maintenance of trial web-sites
- maintenance of TMF and ISF
- adverse event monitoring and reporting
- ensuring that compliance with MHRA / ethics / research governance requirements
- designing and implementing appropriate systems for monitoring and reporting
- training trial personnel in implementation of study protocol and procedures
- all aspects of trial monitoring (central, off-site/remote and on-site monitoring)
- monitoring of supporting departments (e.g. Pharmacy, Laboratories)
- deviation and violation management
- database and data management
- database changes
- data queries and validation
- data downloads
- preparation and submission of progress reports and amendments to:-
- funding body / Sponsor
- MHRA
- Research Ethics Committees
- R&D departments in participating NHS trusts
- review and confirmation of recruitment data for NIHR portfolio
- in collaboration with Trial Statisticians
- prepare reports for Trials Steering Committee (TSC) and Independent Data Monitoring Committee (IDMC) meetings
- interim analyses as appropriate
- organisation of TSC, TMG and IDMC meetings
- project management