Clinical Data Management (CDM) is vital in clinical trials for ensuring the collection and management of quality data that adheres to regulatory standards. It involves multiple activities and professionals to process data effectively, ultimately aiming to support ethical drug development and patient health. This document outlines the importance of CDM, activities involved, relevant regulations, and tools used in the field.

1. Welcome
Clinical Data Management importance in Clinical Trial’s
Student’s Name : G . Ramya Reddy
Student’s Qualification :B.Pharmacy
Student ID: CSRPL_INT_OFL_WKD_204/1222
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2. What is Clinical Data Management [CDM] ?
• Clinical data management (CDM) is the process of collecting and managing research data
in accordance with regulatory standards to obtain quality information that is complete and
error-free.
• The goal is to gather as much such data for analysis as possible that adheres to federal,
state, and local regulations.
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3. CLINICAL DATA MANAGEMENT [CDM]
• Clinical data management (CDM) consists of various activities involving the handling of
data or information that is outlined in the protocol to be collected/analyzed. CDM is a
multidisciplinary activity
• Drug developers should ensure that the data submitted to regulatory bodies is definitive
from an ethical point of view.
• It helps to make efficient treatment decisions and ultimately affects patient health.
• For this, the quality of clinical trial data is crucial.
• To achieve this quality data, researchers need to have proper data management in clinical
trials using clinical data management platforms
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4. • This module will provide an overview of clinical data management and introduce the
CCR’s clinical research database. By the end of this module, the participants will be able
to:
• Discuss what constitutes data management activities in clinical research.
• Describe regulations and guidelines related to data management practices.
• Describe what a case report form is and how it is developed.
• Discuss the traditional data capture process.
• Describe how protocols are developed
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6. Clinical Data Management (CDM)
• Clinical Data Management (CDM) is a critical phase in clinical research, which
leads to the generation of high-quality, reliable, and statistically sound data from
clinical trials.
• This helps to produce a drastic reduction in time from drug development to
marketing.
• Team members of CDM are actively involved in all stages of clinical trials right
from inception to completion.
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7. Clinical Data Management
• A multi-disciplinary activity that includes:
• Research nurses
• Clinical data managers
• Investigators
• Support personnel
• Biostatisticians
• Database programmers
• Various activities involving the handling of information outlined in protocol
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9. Clinical Data Management Activities
• Data acquisition/collection
• Data abstraction/extraction
• Data processing/coding
• Data analysis
• Data transmission
• Data storage
• Data privacy
• Data QA
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10. Tools for CDM
• Many software tools are available for data management, and these are called Clinical
Data Management Systems (CDMS). In multicentric trials,
• a CDMS has become essential to handle the huge amount of data. Most of the CDMS
used in pharmaceutical companies are commercial, but a few open source tools are
available as well.
• Commonly used CDM tools are as follows
 ORACLE CLINICAL,
 CLINTRIAL,
 MACRO,
 RAVE,
 eClinical Suite
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11. CDM Process
• The CDM process, like a clinical trial, begins with the end in mind. This means that the whole process is
designed keeping the deliverable in view.
• As a clinical trial is designed to answer the research question, the CDM process is designed to deliver an error-
free, valid, and statistically sound database.
• To meet this objective, the CDM process starts early, even before the finalization of the study protocol.
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12. Regulations, Guidelines, and Standards in CDM
• In clinical research, CDM has guidelines and standards that must be followed. Since the
pharmaceutical industry relies on electronically captured data for the evaluation of medicines,
• There is a need to follow good practices in CDM and maintain standards in electronic data
capture. These electronic records have to comply with a Code of Federal Regulations (CFR),
21 CFR Part 11.
• This regulation is applicable to records in an electronic format that are created, modified,
maintained, archived, retrieved, or transmitted.
• Society for Clinical Data Management (SCDM) publishes the Good Clinical Data
Management Practices (GCDMP) guidelines, a document providing the standards of good
practice within CDM.
• GCDMP was initially published in September 2000 and has undergone several revisions
thereafter. The July 2009 version is the currently followed GCDMP document.
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13. Thank You!
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