Clinical sas course syllabus
- 1. SoftlogicSystemsPvt. Ltd www.softlogicsys.in|86818 84318 Clinical SAS Course Syllabus: The syllabus of will be framed as per the requirement of corporate. We are mainly concentrating in the following syllabus Introduction to drug discovery and development process Overview of highly regulated drug development process, from discovery to bringing a biopharmaceutical product to market. Understanding major phases (Phase I – IV) of clinical trials and clinical data management Food and Drug Administration (FDA) regulations and Guidance (21 CFR part 11, GCP, eCTD) Regulatory overview and approval process including IND/NDA to FDA Types and parameters of Clinical trial Getting in depth knowledge about the functional group and working of CRO/Pharmaceutical industry and knowing in and out of guidelines pertaining to company involved in clinical trials Learning about the general department structure of pharmaceutical industry, roles and responsibilities of SAS programmer in the company Understanding clinical study and documents {e.g. Protocols, Case Report Form (CRF), annotated and electronic Case Report Form (aCRF and eCRF), Statistical Analysis Plan (SAP)} Learning more about types of analysis in clinical trials (Pharmacokinetic, Pharmacodynamics, Efficacy, Safety, etc.) Introduction to Clinical Trial Data Learn to prepare and clean clinical trial data Know how to categorize and summarize clinical data Studying and classifying different types of clinical trial data {Safety (ISS) and Efficacy (ISE) Data} Getting acquainted with new Clinical Data Interchange Standards Consortium (CDISC) Implementation in categorizing clinical data. Using SAS to Create Analysis Data sets Key concepts for creating and transforming analysis data sets (Using DATA steps and PROC TRANSPOSE)
- 2. SoftlogicSystemsPvt. Ltd www.softlogicsys.in|86818 84318 Comparing Data sets using PROC COMPARE Understanding and creating Time-to-Event, Change-from-Baseline, Critical variables data sets. Generate Customized Clinical Trials Tables, Listings and Graphs/Figures Using PROC TABULATE to create clinical trial tables Using PROC REPORT to report clinical trials tables and listing Creating summaries of Adverse Event, Concomitant medication, Laboratory data using DATA steps and various SAS Procedures Creating Kaplan-Meier Survival Tables using PROC LIFETEST or PROC GPLOT Using ODS with PROC REPORT and PROC TABULATE to generate nice looking tables and Listings. Generating Graphs and Plots using SAS/BASE, SAS STAT and SAS/GRAPH Producing Bar and Pie charts using PROC GPLOT and PROC GCHART Creating Box and Scatter Plot using PROC BOXPLOT, PROC GPLOT and PROC UNIVARIATE Performing Common Analyses and Obtaining Statistics Obtaining Descriptive Statistics Obtaining Inferential Statistics from Categorical Data Analysis Obtaining Inferential Statistics from Continuous Data Analysis Obtaining Time-to-Event Analysis Statistics Performing Common Analyses and Obtaining Statistics Using the SAS XPORT Transport Format Creating XML Files
- 3. SoftlogicSystemsPvt. Ltd www.softlogicsys.in|86818 84318 _________________________________________________________________________________________________________ For more details about our training, Please call me at +91 86818 84318 or email me at enquiry@softlogicsys.in | www.softlogicsys.in _______________________________________________________________________________________ ****