GHTU Trial Management
GHTU staff offer services and research possibilities for global health trials.
Our support and advice features include:
- Protocol, Participant Information Sheet (PIS), Case Report Form (CRF) and Informed Consent Form (ICF) development
- Budget allocation advice
- Grant and Funding applications
- Governance oversight
- Operational advice/oversight
- Investigational Medicinal Product (IMP) management
- Research ethics committee and regulatory applications
- Quality control procedures
- Participant recruitment
- Site Initiation and staff training
- Prepare and maintain Trial Master File (TMF)
- Prepare and disseminate Investigator Site File (ISF) and Pharmacy Site File (PSF)
- Arrangements for Trial Steering Committees (TSC), Data and Safety Monitoring Boards (DSMB) and Trial Management Groups (TMG)