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Course Content
Clinical Trials And Clinical Data Management
- A clinical data management system or CDMS is a tool used in clinical research to manage the data of a clinical trial. In this module, you will learn Data management plan, Clinical data management process, Different types of phase trials and many more concepts.
- Phase trails: preclinical 1,2,3 and 4
- Drug discovery and development
- ICH GCP
- Computer system validation
- 21 CFR 11
- CRF designing
- Pharmacokinetics
- Pharmacovigilance
- Clinical data management process
- CDISC introduction
- CTM Systems
- Data management plan
Sub Chapter
- This module gives you a description of Clinical Trail monitoring system, CRA, its responsibilities, How to monitor CRA, FDA guidelines, history and many more.
- General abbreviated terms
- Introduction to clinical trails
- Responsibilities of CRA
- Activities of CRA in house
- CRA monitoring
- Clinical trail monitoring
- Responsibilities of PI
- IRB
- Informed consent form
- ICH history
- GPC guidelines
- FDA history
- FDA guidelines
- IND
- NDA reviews
- Clinical research study document
- CRF reviews and sample CRF’s
- CRF data submission, CRF receiving
- Introduction to SAS in CDM
Components Of SAS Different Data Types
- Learn all about SAS different data types in this module of training.
- Base/SAS
- SAS/STAT
- SAS/Graph
- SAS/ACCESS
- SAS procedures
- SAS Macros
- SAS (working with sql)
Open Clinical
- By the end of this module, you will have a good understanding of Database design, protocol planning and CRF data entry.
- Database design
- Protocol planning
- CRF Data entry
- Data management
- Study planning
- Study design
- Oracle clinical (overview)
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