ADVANCED CERTIFIED PROGRAM IN CLINICAL DATA MANAGEMENT ON ORACLE CLINICAL AND ORACLE CENTRAL DESIGNER/INFORMGratisol Academy Of Clinical Research
- 4 hours of class
Frequent Asked Questions
Minimum Eligibility Criteria For Application To The Course Would Be Either Of The Following: Applicants are recommended to have one of the following life Science degrees: Bachelor's, Master’s, or PhD, MBBS/ MD/B.D.S /M.D.S/ B.A.M.S / B.H.M.S /B.P.T/ B.Tech (Biotechnology / Pharmaceutical Science) / M.Tech (Biotechnology), B. Pharm /M.Pharm /BVSC / B.Sc. (Nursing) / B.Sc./M.Sc, M.Pharmacy, M.Sc /MA (Statistics) and all professionals working with Pharmaceutical companies, CROs and Hospital.
What you'll learn on the course
Clinical Data Management
Clinical Database Design
Teachers and trainers (1)
Clinical Data Management is a branch of Clinical Research concerned with managing and processing the data gathered during clinical trials. Clinical Data Management (CDM) is recognized as the crux of Drug Development process. It satisfies the specialized needs of the critically important Drug Development in terms of quality, accuracy, verifiability, consistency and above all, conformity to local regulations, and GCP. CDM plays a vital role in Drug Development and Clinical Trials. It assures integrity & quality of data being transformed from trial CRF to database system. The course comprises theory and practical sessions, case study assignments, and exercises. During all practical sessions, the students will get hands-on experience on Clinical Data Management software and its applications.
This course will provide extensive training in the niche domain of clinical data management. It incorporates end-to-end theoretical & practical training sessions on Oracle Clinical, Remote Data Capture (RDC) & Oracle Inform Central Designer.
Following Course Content will be covered during the training:
- Welcome and Introduction to Clinical Data Management
- Drug Development and Clinical Trial Phases
- Fundamentals of Clinical Research & Roles in a CRO
- Clinical Data Management Process & Life cycle
- ICH – GCP guidelines
- GCDMP guidelines
- Paper Vs Electronic Data capture
- Data Management Plan document
- Introduction to CDISC SDTM Standards
- Application of SDTM Standards.
- Clinical Study Documentations Setup
- CRF Annotation
- Creation of SDTM annotated CRF
- Creation of Database Structure Document
- Creation of Edit Check Specification Documents
- Study User Acceptance Test (UAT) documents
- Project Initiation
- CRF Design/ eCRF design
- 21 CFR Part 11 Regulations
- Questions and Discussions