CTMS
Clinical Trial Management System: operational management and tracking of the study.
Simulators
Clinical Research Simulators for Professional Practice
Hands-on clinical research training through simulations of systems, documentation and situations related to professional work.
Not only learning what a CRA does, but practicing how a CRA thinks, analyzes and decides.
Simulations are designed to build practical application and professional judgment: working on real documentation, spotting inconsistencies and justifying decisions the way it is done inside a study.
Systems and documentation you practice with
CRF / eCRF
Case Report Form: patient data entry, review and validation.
TMF
Trial Master File: organization and control of essential study documentation.
IWRS / IRT
Randomization and investigational product supply management.
Simulated situations
Beyond the systems, practice covers documents and situations from day-to-day work.
Practice
- Informed consent
- Source Data Verification (SDV)
- Source Data Review (SDR)
- Medical records as source data
- Investigational product
- Monitoring visits
- Discrepancy management
- Study documentation
Why practice with simulators
In clinical research, judgment is built by working on cases: reviewing a data point, checking it against the source document, identifying a deviation and deciding how to act.
Simulators make that experience possible during training, in a controlled environment and with instructor feedback, before facing it in a real study.
Frequently asked questions about simulators
What are clinical research simulators?
They are practice environments that reproduce the systems and documentation of a clinical trial — CTMS, CRF/eCRF, TMF and IWRS — so the tasks of the role can be trained without working on real patient data.
How can I practice Source Data Verification?
Within the program, SDV is practiced by checking the data entered in the CRF against simulated source documentation, identifying discrepancies and recording the corresponding actions, with instructor feedback.