Prajakta Khobragade RSD and SHB

8/12/2019 Prajakta Khobragade RSD and SHB

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STUDENT HANDBOOK

AND

REQUIREMENT SPECIFICATION DOCUMENT

- Prajakta Khobragade


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Introduction and Objective

Raw datasets contains the information collected at the trial sites during clinicaltrials.

This information can be in Excel sheets or SAS datasets.

These raw datasets act as input for the Analysis Datasets which contains a lot ofadditional 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 DatasetsRaw Datasets and Analysis DatasetsStandard Artifacts

STUDENT HANDBOOK


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Output

Assignment Related-

Modified Initial.SAS

Adlb.SASAdlb.log

Adlb.sas7bdat

Supporting Document-

Updated Issue Log

Developers Checklist

Minutes of Meeting

Assignment Tracking Sheet

Milestone Tracking Sheet

STUDENT HANDBOOK


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ProcedureCheck 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


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Update the Developers Testing Checklist

And archive and submit all deliverables as per RSD and SHB.


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Folder Structure

01Study_files -------- ADD001RSD, ADD001SHB, Issue log, MOM, TrackingSheets and Developers Checklist

02data_raw ------------- Raw datasets

03data_analysis -------- Output dataset04utility ----------------- Issue Log

05pgm_setup

06macrolib

08pgm_analysis -------- SAS code for Analysis dataset

09out_logs ------------- Log

10out_listing

11out_tables

12out_graphics

13validate

STUDENT HANDBOOK


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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


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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


DOCUMENT


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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 thework 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


DOCUMENT


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THANK YOU

Documents

Prajakta Khobragade RSD and SHB