Course Overview
SAS Clinical Data Integration supports the pharmaceutical-industry needs for transforming, managing, and verifying the creation of industry-mandated data standards such as those created by Clinical Data Interchange Standards Consortium (CDISC). To reduce the possibility of errors due to human entry, the systems employ various means to verify the data.
SAS CDM Training ConceptsClinical Trails and Clinical Data Management:
Phase trails: preclinical, Drug discovery and development, ICH GCP, Computer system validation, CFR, CRF designing, Pharmacokinetics, Pharmacovigilance, Clinical data management process, CDISC introduction, CTM systems, Data management plan
Sub Chapter
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
Base/SAS, SAS/STAT, SAS/Graph, SAS/ACCESS, SAS procedures, SAS Procedures, SAS Macros, SAS (working with sql).
Open clinical
Data base design, Protocol planning, CRF Data entry, Data management, Study planning, Study design, Oracle clinical (overview).
Highlights
