Regulatory Documents

• ICH GCP – E3, E6, E8 Guidelines 

• 21 CRF PART 11 

• CDISC – CDASH, SDTM, ADAM, Define.xml 

Study Level documents

• Protocol, SAP, CRF, ACRF 

• EDC database, About RAW data 

Dictionaries & Versions

• MEDDRA / WHODDrug 

• Overview of Clinical Trails 

• Drug development phases  

• PreClinical, phase 1 to 4, IND, NDA approvals, Ethics committee 

• Objectives (Primary, Secondary), End points (Primary, Secondary) 

• SAS software introduction, web application, create student account, setup 

• SAS introcution, uses in diffferent domains/sectors 

• Different tabs in SAS softeware and its importance- Code, Log, Ouput, files 

• About PDV concept 

• Accessing data – Libraries, storage folders, Datasets, Variables, Columns 

• libname statement 

• filename statement 

• infile statement – to read external data into sas 

• Dictionary.vcolumn 

• Dictionary.tables 

• Creating SAS Data Sets – Data steps/proc steps 

• Understanding DATA Step Processing 

• SET, KEEP, DROP, RENAME statements 

• SAS Language Errors – Identifying and Correcting them 

• SAS libraries – Default (work) & User defined. SASHELP.Class, Car’s datasets 

• SAS naming conventions for Library, Dataset, Variable

Using Functions to Manipulate Data

• Mathematical – ABS, LOG, SUM, MIN, MAX, AVG, STD, count 

• Character – cat, compress, strip, left, trim, scan, substr, compbl, lowcase, upcase, propcase, tranwrd, translate, index, find 

• Date & time – today, time, mdy, intck 

• Truncation – round, ceil, floor 

• Other – input, put, length, cmiss, nmiss, n, lag 

• Statements – label, Sum, Keep, drop, rename, output, length, format, put, input, options, title, footnotes 

• Options – Keep, drop, rename, label, 

Filtering data & conditional flag/output 

• WHERE 

• IF condition 

• IF – THEN condition 

• Where VS IF 

DO Loops

• DO loops – nested do-loop – creating dummy datasets 

• ARRAYS with DO loops 

Combining SAS Data Sets

• with SET statement 

• with MERGE statement 

• one-to-one or one-to-many merging 

Creating Reports / Creating Outputs

• data _NULL_; 

• Proc print and ODS system (.rtf,.pdf,.xls) 

• Proc contents 

• Proc sort 

BY-Group Processing

• SUM/RETAIN statement 

• FRIST.VAR and LAST.VAR variables. 

Types of Statistics   

• Discritive – data is summarised through the given observations 

• Inferential – used to interpret the meaning of Descriptive statistics(p-value) 

• and used to compare the differences between the treatment groups. 

• proc append, SET statement 

• Proc report 

• proc freq 

• proc means/summary 

• proc univariate 

• proc format, informat proc transpose 

• Proc Tabulate 

• proc import 

• proc export 

• proc glm 

• proc t test 

• proc corr 

• proc chart 

• proc plot 

• Proc compare 

Advance SAS topics

• Macro definition, uses 

• Parameters – keyword, positional 

• Creating macro var using diff. ways 

• Example with data steps, Do loops & PROCs 

• PROC SQL 

• JOINS 

• Flags creation 

• apply conditions 

• Calculations 

• Functions 

Domain  

SDTM v3.2

• Introduction, mapping specifications 

• Types of Domains/classes 

Types of flags

• Trial Domains 

• DM 

• AE 

• CM 

• VS 

• LB 

ADAM v1.0

• ADAM IG for introduction 

• Mapping Specification 

• Types of Domains/classes, Complex derivations 

• ADSL, common/core vars, Derivations like study day 

• ADAE 

• ADVS  

Introduction, Mockshells, stats team 

Tables

• Demographic  

• Ae summary 

• cm summary 

• VS table 

Listings

• Demographic  

• Ae summary 

• cm summary 

Figures

• About Clinical SAS industry 

• different SAS Roles/designations 

• edit checks team/clinical sas team 

• bio stats team 

Roles in SAS Programming

• Developer 

• Validator 

• Reviewer (Manager/Senior Programmer) 

• Issue logs (for Raw, SDTM, ADAM, TFLs) 

• Different types of analysis 

• Study Delivery timelines 

• Pinnacle 21 

• USFDA submission docs – SDRG, ADRG, Define