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SAS CDM Online Training



Clinical Trails and Clinical Data Management Duration: 40 hrs Introduction Drug discovery and development Phase trails: preclinical1,2,3 and 4 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 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)

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