Unit 1 - Introduction to Clinical Data Management and SOPs

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Clinical Trial
What is Clinical Trial?

As per ICH GCP- Section 1.12 Clinical Trial/Study

Any investigation in human subjects intended to discover or verify the clinical, pharmacological

and/or other pharmacodynamic effects of an investigational product(s), and/or to identify any

adverse reactions to an investigational product(s), and/or to study absorption, distribution,

metabolism, and excretion of an investigational product(s) with the object of ascertaining its

safety and/or efficacy. The terms clinical trial and clinical study are synonymous

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Multidisciplinary Teams in CT

Clinical
Investigator

Pharmacovigilanc
Site coordinator
e

Clinical Data
Management Clinical Biostatistician

Trials
Regulatory affairs Project manager

Ethics committee Monitor

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Introduction to CDM
What is Clinical Data Management?

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 of such data for analysis as possible that adheres to federal,

state, and local regulations.

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Why CDM
• Review & approval of new drugs by Regulatory Agencies is dependent upon a trust that clinical trials

data presented are of sufficient integrity to ensure confidence in results & conclusions presented by

pharma company

• Important to obtaining that trust is adherence to quality standards & practices

• Hence companies must assure that all staff involved in the clinical research are trained & qualified to

perform data management tasks

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DM Role in Clinical Research
CDM has evolved from a mere data entry process to a much diverse process today
• The data management function provides all data collection and data validation for a clinical trial
program

• Data management is essential to the overall clinical research function, as its key deliverable is the data to
support the submission

• Assuring the overall accuracy and integrity of the clinical trial data is the core business of the data
management function

• It provides data and database in a usable format in a timely manner

• It ensures clean data and a ‘ready to lock’ database

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Definition of Data
Data with reference to CDM means the

• Patient Information which is collected during Clinical trial.

• Data is collected to establish whether the objective of the Clinical Trial is met

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Important Abbreviations
• DM – Data Management

• CRF – Case Report Form

• DB – Database

• QC – Quality Control

• DMP – Data Management Plan

• CSR – Clinical Study Report

• UAT – User Acceptance Test

• DBL – Database Lock

• CDISC - Clinical Data Interchange Standards Consortium

• SDTMIG - Study Data Tabulation Model Implementation Guide for Human Clinical Trials

• CDASH - Clinical Data Acquisition Standards Harmonization

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CDM Overview

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Objective of CDM
Data Collection --
• Paper, Electronic and Remote data capture

Data integration --
• Integration of data received from all sources in a single DB.

System / Data Validation --

• Ensures consistency and correctness System validation done via UAT, QC and
Programming Data Validation via Edit check programs and manual review

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Scope of CDM
• Main scope of CDM is to Collect, Validate and Analyze the clinical data

• Design and development of

• data collection instrument such as Paper CRF, Electronic CRF, Clinical database etc

• tools for Validation such as Edit Checks, User Acceptance Testing etc

• tools for Analyzing data such as DDR/DDS (Derived Dataset Requirement/Specification)

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Importance of CDM
CDM is a vital vehicle in Clinical Trials to ensure integrity & quality of data being transferred from trial

subjects to a database system. It helps :

• To provide consistent, accurate & valid clinical data

• To support accuracy of final conclusions & report

Clinical Data Management ensures:

• That collected data is complete & accurate so that results are correct

• That trial database is complete, accurate & a true representation of what took place in trial

• That trial database is sufficiently clean, to support statistical analysis, its subsequent presentation & interpretation

• At the study level, data management ends when the database is locked and the Clinical Study Report is final

• At the compound level (of the drug), data management ends when the submission package is assembled and complete
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CDM Communication and interfaces

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Interdependent groups in CDM

Data Cleaning

Programming Biostatistics

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CDM Activities – At different stage of study

Conduct
• CRF Design Phase • Database QC
• Data Base Design • Database Lock
• Edit Check • Data Entry
• Database Activated • Query Management
• Coding of Medical Terms
• SAE Reconciliation
• Data Base Update
Start Up Closeout
Phase Phase

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CDM Activities – Start Up Phase

Protocol

CRF Design

Database • QC at each step

Design • To & Fro Communication

Validation/
Deviation
Procedure

Database
Activation 16
CDM Activities – Conduct Phase
Data
Database Entry/Loading Discrepancy
Activation (CRF and external Management
data)

Safety Data
Coding Terms
Reconciliation

Query
Resolution

Resolution and
Update DB

Manual Check &

QC
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CDM Activities – Closeout Phase

Safety Data
Reconciliation

Discrepancy Query Resolution and/or

Management Generation Update DB

Manual Check, QC
Coding Terms
& CRF Tracking

DB Lock and
freeze

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CDM Activities – Startup to Closeout Phase
Start up phase Conduct phase Closeout phase

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CDM Activities – Start Up Phase
Roles and Responsibilities
CRF Designers -Design CRF as per protocol

DB designers -Design DB as per protocol OR CRF OR CRF Specs and activate the same

Programmers -Program Validation and Derivation procedures, and activate the same

Data Managers -Review the CRF prior to activation, test the database prior to activation, write the

validation and derivation procedures/checks and test the same prior to activation

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CDM Activities – Conduct & Closeout Phase
Roles and Responsibilities
Data Entry/Data Loaders- Manually enter the data (in case of paper studies), load data in case of

electronic studies) and external data (Example: lab, ECG, subject diaries etc.)

Data Managers -Identify and resolve discrepancies, issue queries to site & resolve them, carry out manual

checks, lab review and CRF tracking

Safety Data Managers -Perform the safety reconciliation by comparing the clinical database with the

safety database

Dictionary Coders -Code medical terms collected during clinical trial. Example: Medications and Adverse

events
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Data Capture Tools
• Paper Based eCRF

• Electronic Based eCRF

• Differences:

Paper eCRF Electronic eCRF

Data is entered on Paper Case Report Data is captured in electronic Case

Form Report Form

Data Entry associate will enter the Investigator enters the data into the
data in to the Clinical Data base database

Real time access to the data Remote

No real time access to the data
data entry/ capture
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