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

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RoleResponsibility
SponsorCompany responsible for the trial (may outsource tasks to a CRO but stays accountable)
CROContract 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 monitorPhysician who reviews safety and medical data
Biostatistician / statistical programmerAnalysis plan, datasets, tables and figures
PharmacovigilanceManages serious adverse event reporting