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Clinical Trails 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
- Clinical data management process
- CDISC introduction
- CTM systems
- Data management plan
- This module gives you an description about Clinical Trail monitoring system, CRA, its responsibilites, 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
- Informed consent form
- ICH history
- GPC guidelines
- FDA history
- FDA guidelines
- 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.
- SAS procedures
- SAS Macros
- SAS (working with sql)
- By the end of this module, you will have a good understanding about Data base design, protocol planning and CRF data entry.
- Data base design
- Protocol planning
- CRF Data entry
- Data management
- Study planning
- Study design
- Oracle clinical (overview)