Before a study can proceed in the CRF, investigators must provide the following documentation:
- Study protocol.
- Informed consent form and patient information leaflet.
- Research Ethics Committee application and approvals.
- Health Products Regulatory Authority (HPRA) approval (if the research is a clinical trial).
- CVs, current medical registration, GCP certificate and Basic Life Support certificate for medical and nursing staff.
- St. James’s Hospital Research & Innovation Application / Registration Form.
Applications to the CRF can be made in tandem with ethics and HPRA applications. In such cases, a copy of the ethics and HPRA approval letter must be submitted to the Operational Management Team before a project can commence.
Please submit completed applications and supporting information to: firstname.lastname@example.org
Derval Reidy – Assistant Director of Nursing, Wellcome HRB Clinical Research Facility