Guided Notes
Trial Team Roles & the Clinical Systems Landscape
Sponsor, CRO, site, CRA, medical monitor, biostatistics and safety roles; the system landscape (EDC, CTMS, IRT, eTMF, safety database, ePRO, labs) and how data flows between them.
Who's who
Slide 1 / 5| Role | Responsibility |
|---|---|
| Sponsor | Company responsible for the trial (may outsource tasks to a CRO but stays accountable) |
| CRO | Contract research organization running parts of the trial (data management, monitoring…) |
| Principal Investigator (PI) | Doctor responsible at the site |
| Clinical Research Coordinator (CRC) | Site staff who enrolls patients and enters data |
| Clinical Research Associate (CRA/monitor) | Visits sites, verifies data against source, checks GCP |
| Medical monitor | Physician who reviews safety and medical data |
| Biostatistician / statistical programmer | Analysis plan, datasets, tables and figures |
| Pharmacovigilance | Manages serious adverse event reporting |