STUDENT HANDBOOK

AND
REQUIREMENT SPECIFICATION DOCUMENT

- Prajakta Khobragade
Introduction and Objective
Raw datasets contains the information collected at the trial sites during clinical
trials.
This information can be in Excel sheets or SAS datasets.
These raw datasets act as input for the Analysis Datasets which contains a lot of
additional analysis-related information based on raw datasets.
Excel files can be read with the help of DDE or Procedure Import.
Requirements
Requirement Specification Document (RSD)
Input Datasets Raw Datasets and Analysis Datasets
Standard Artifacts




STUDENT HANDBOOK
Output
Assignment Related-
Modified Initial.SAS
Adlb.SAS
Adlb.log
Adlb.sas7bdat
Supporting Document-
Updated Issue Log
Developers Checklist
Minutes of Meeting
Assignment Tracking Sheet
Milestone Tracking Sheet

STUDENT HANDBOOK
Procedure
Check if all the inputs are present in the folder
If not, inform the supervisor

Read and follow SOPs and guidelines documents which are accessible through Common
Document folder

Modify and Execute Initial.sas


Read RSD very carefully
If there are any Queries ,
update your issue log

Proceed to write SAS code to create ADLB dataset


Check whether your Issue Log is clean



Update the Developers Testing Checklist


And archive and submit all deliverables as per RSD and SHB.
Folder Structure
01Study_files -------- ADD001RSD, ADD001SHB, Issue log, MOM, Tracking
Sheets and Developers Checklist
02data_raw ------------- Raw datasets
03data_analysis -------- Output dataset
04utility ----------------- Issue Log
05pgm_setup
06macrolib
08pgm_analysis -------- SAS code for Analysis dataset
09out_logs ------------- Log
10out_listing
11out_tables
12out_graphics
13validate
STUDENT HANDBOOK
The Requirement Specification Document (RSD) lays down the detailed
specifications required to accomplish the Analysis Dataset development task.
The RSD defines the variables required, their algorithm and other details which
need to be followed while developing the Analysis Dataset.
RSD or Requirement Specification Document contains
Project Title
Description
Input
Dataset Specification
Output
Any Additional Information


REQUIREMENT SPECIFICATION
DOCUMENT
Input Dataset
Lb Dataset (laboratory raw dataset)
ADSL Dataset (Analysis Subject Level Dataset)
Labtest.xls (list of laboratory tests required for analysis)
Adlb_paramcd.csv
Output Dataset
Adlb Dataset
REQUIREMENT SPECIFICATION
DOCUMENT
Writing the Code
i. Define the SAS library with the help of %include
ii. Read the .csv and .xls files and sort and merge the SAS datasets
iii. Assign avisit and avisitn
iv. Calculate mean of base , change from baseline and percent change from baseline
v. After deleting duplicate observations , assign minimum, maximum and last flags
vi. Assign acat and acatn
vii. Assign Criteria flags and label the variables
viii. Keep the variables that are needed in the adlb dataset and label the dataset
ix. After saving the dataset in the 03data_analysis folder delete the temporary files from the
work library
x. Using Procedure Printto save the log file in the 09out_log
xi. And archive and submit all the essentials to their respective folders

REQUIREMENT SPECIFICATION
DOCUMENT
THANK YOU