Clinical Research and Clinical Trials: Intermediate
Go from coordinator to clinical research professional: risk based monitoring, CRA skills, data management to database lock, and pharmacovigilance.
- Duration
- 8 weeks
- Level
- Intermediate
- Content
- 48 lessons
- 8 modules · 15 h 8 min
- Certificate
- Included
- On completion
- Access
- Fee by email
What you'll learn
Who this course is for
- Beginner level graduates ready to move into CRA or clinical data management roles
- Clinical Research Coordinators who want structured, professional level monitoring and data skills
- Professionals preparing for ACRP CCRA or SOCRA CCRP certification examinations
- Anyone who wants hands on experience with risk based monitoring and pharmacovigilance
Skills you'll gain
This course includes
Course content
8 modules · 48 lessons · 15 h 8 min
Advanced GCP and quality systems, clinical monitoring and the CRA role, risk based monitoring and trial oversight, site management recruitment and project delivery, a minor project running a full monitoring engagement, clinical data management and biostatistics, pharmacovigilance safety and regulatory submissions, and a major project managing a complete study lifecycle.
Requirements
- Completion of the Beginner level, or working knowledge of ICH GCP, trial design, informed consent, source documentation, and site operations
- A computer with a reliable internet connection
- Comfort with basic clinical research terminology and documentation
About this course
Level up from coordinator to clinical research professional. This intermediate program from Ucanly takes practitioners with working knowledge of ICH GCP, trial design, informed consent, source documentation, and site operations into professional monitoring and data management: advanced GCP quality systems, CAPA methodology, and the Clinical Research Associate role across SIV, IMV, and COV visit types. You will master risk based monitoring, building oversight plans with defined key risk indicators and centralized statistical signal detection, and in your minor project in week five, run a complete monitoring engagement including source data verification, a findings report, and a CAPA plan. You will build clinical data management skills through database lock, CDISC CDASH and SDTM standards, and biostatistics fundamentals, then move into pharmacovigilance with MedDRA coding, SUSAR reporting, and regulatory submissions including the eCTD. You will graduate having managed a complete study lifecycle in your week ten major project as both a Clinical Research Associate and data professional, covering startup, risk based monitoring across sites, data management to database lock, safety case processing, inspection readiness, and a clinical study report contribution. All studies, subjects, and data used in this program are entirely simulated, and this program teaches ethical, compliant clinical research practice only.
Earn a Ucanly certificate
Complete this course to earn a Ucanly certificate with its own page and QR code. Save it as a PDF, share its link, or add it to the certifications on your LinkedIn profile.
Frequently asked questions
It is recommended, but working knowledge of ICH GCP, trial design, informed consent, source documentation, and site operations is sufficient to start.
No, all studies, subjects, and data used in this program are entirely simulated. This program teaches ethical, compliant clinical research practice only, and never substitutes for regulatory or medical judgement.
Yes, you will build skills as both a Clinical Research Associate running risk based monitoring and a data professional managing databases to lock, including pharmacovigilance and regulatory submissions.
A full study lifecycle managed as a Clinical Research Associate and data professional, covering startup, risk based monitoring across sites, data management to database lock, safety case processing, inspection readiness, and a clinical study report contribution.