The document outlines the process for setting up clinical data management and pharmacovigilance processes. It discusses developing the protocol and case report forms, designing the database, installing software like Oracle Inform and Argus, and preparing documents like the data management plan. It also describes the data entry, validation, query resolution, medical coding, biostatistics, and database locking and freezing aspects of the clinical data management and pharmacovigilance setup process.

1. CLINICAL DATA MANAGEMENT
PROCESS SETUP
PHARMACOVIGILANCE PROCESS
SETUP

2. CDM /PV Process setup
 CLINICAL DATA MANAGEMENT PROCESS
 PHARMACOVIGILANCE PROCESS
 ORACLE INFORM SOFTWARE
INSTALLATIONAND IMPLEMENTATION

3. CDM /PV Process setup
 ORACLEARGUS SOFTWARE INSTALLATION
AND IMPLEMENTATION
 SAS CLINICAL SOFTWARE INSTALLATION
AND IMPLEMENTATION
 RECRUITMENT

4. CDM /PV Process setup
 Finalized Protocol
 CRF (Case report form )Designing
 Database designing

5. CDM /PV Process setup
 DATA MANAGEMENT PLAN Document
preparation
 Quality control Process for Database Design

6. CDM /PV Process setup
 Preparation of EDC (Edit check document)
 Data Entry –First Pass /Second Pass
 BatchValidation
 Data Descrepancy

7. CDM /PV Process setup
 Descrepant data flagged in the form of
queries
 Raising the queries to the sites
 Queries will be raised in the from of DCF(Data
clarification form)

8. CDM /PV Process setup
 Sites will resolve the Queries and revert back
to DM
 Medical History, Adverse Events,
Concomitant Medications, Surgical History
are coded using Medical Dictionaries
(MEDdra,WHODD

9. CDM /PV Process setup
 Biostatistics
 TLG Generation
 Data base locking
 Database Freezing