SAS Clinical Data Management Online Training

SAS Clinical Data Management online training course content concepts :

Clinical Trails and Clinical Data Management : 

1.Phase trails: preclinical1,2,3 and 4

2.Drug discovery and development

3.ICH GCP

4.Computer system validation

5.21 CFR 11

6.CRF designing

7.Pharmacokinetics

8.Pharmacovigilance

9.Clinical data management process

10.CDISC introduction

11.CTM systems

12.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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Resource: Online-training-sas.com