Clinical Data Management (CDM) involves the systematic collection, cleaning, and reporting of data from clinical trials to ensure high quality and integrity for statistical analysis, adhering to FDA and ICH guidelines. Various data collection methods include paper or electronic records, interactive systems, electronic data capture, and direct patient reporting. CDM systems, such as Oracle Clinical and Medidata Rave, are used to manage and analyze data, employing coding and statistical tools to evaluate drug safety and efficacy.

1. INTRODUCTION TO
CLINICAL DATA
MANAGEMENT
PRESENTED BY-
MONIKA MOHANTY
IQVIA BANGALORE

2. CONTENTS-
1- CLINICAL DATA MANAGENT- OVERVIEW
• Clinical data and collection tools
• Clinical data management system
• Data Analysis
2- Clinical Data Management Team

3. CLINICAL DATA
MANAGENT-
OVERVIEW
CDM is the process of collecting, entering,
cleaning and reporting of data recorded in
clinical trials. It is the technology that
manages clinical data to produce the high
quality, clean and analyzable database. It is
performed in accordance with applicable
FDA and ICH guidelines and regulations.
CDM team is responsible for ensuring that
the clinical data collected throughout the
clinical trial is complete, accurate and of the
highest quality and integrity which can be
made available for statistical analysis.

4. CLINICAL DATA AND DATA COLLECTION TOOLS-
• There are various different methods available to collect the data in CDM which
are discussed below-
1- PAPER OR ELECTRONIC MEDICAL
RECORDS-
If medical records are collected in
paper form and then they are enter
into respective CRF fields; if records
are available electronically then
they are transferred electronically
to the database.
2- INTERACTIVE VOICE RESPONSE
SYSTEMS-
A technology that automates
interaction with telephone and
communication system, allows
for an efficient exchange of
information to from a database.

5. 3- EECTRONIC DATAL CAPTURE (EDC)-
It is a computerized system designed for the
collection of clinical trial which replace
traditional paper based data collection
methodology. It is widely accepted by
pharmaceutical company and CROs.
4- FILE TRANSFERS-
Data collection through file transfer by Electronic
data interchange (EDI) is the exchange of
documents in standardized electronic form
between organization in an automated manner
directly from a computer application from one
organization to an application in other
organization.
5- ELECTRONIC PATIENT REPORT OUTCOME-
It is a system for data collection directly
from patients, where data collection can
be done through IVRS, Web or tablets.

6. CLINICAL DATA MANAGEMENT SYSTEM (CDMS)-
• CDMS is used in clinical research to capture, clean and manage the data generated in
clinical trial. The function of CDMS is described below-
• Some of the CDMS primarily in used are-
• Oracle Clinical
• Medidata Rave system
• Clintrial sysytem
1- The clinical trial data
collected at site in the CRF
will be entered and stored in
the CDMS.
• Some of the medical dictionary primarily in
used are-
• MedDRA (Medical Dictionary for regulatory
Acitivities)
• WHO-DD (World Health Organization- Drug
Dictionary)
2- Coding of data in the
CDMS which involves coding
of CRF data into universally
acceptable medical language
using regulatory approved
medical dictionaries.

7. DATA ANALYSIS-
• Clinical data analysis involves analysis of the
clinical trial data which collected, cleaned,
coded and stored in a clinical data base. It is
the process where the data collected during
the process of trials and reviewed during the
CDM is analyzed to decide upon the safety
and efficacy parameters of the drug.
• Analysis is done by TFLs from the data with
the help of statistical analysis software.
• Following are the examples of data analysis
tool-
1- SAS- Statistical Analysis Software
2- STATISTICA
3- IBM SPSS

8. CLINICAL DATA
MANAGEMENT
TEAM-