BridgeSang Pvt Ltd CDM Hand Book

Bridge Sang
The Job Genesis of
the World

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BridgeSang Pvt Ltd CDM Hand Book

Index
Module 1 Clinical Trial
Module 2 Drug Discovery
Module 3 Clinical Trial Design
Module 4 Clinical Trial Management
Module 5 Clinical Research
Module 6 Introduction to Clinical Data Management
Module 7 Coding of Clinical Data and Coding management
Module 8 Coding for adverse event
Module 9 CRF design
Module 10 Data Entry
Module 11 Data Storage and Archival
Module 12 Data base closure
Module 13 Discrepancy Management

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BridgeSang Pvt Ltd CDM Hand Book

Module 1 – Clinical Trial

Introduction to clinical trial
History
Food and cosmetic Act
Nuremberg Code
Kefauver-Harris Amendments
IRB approval
1 What is placebo
2 Write about sulfonamide and thalidomide tragedies
3 Write about food, drug and cosmetic act, 1938

Module 2: Drug Discovery

Introduction
History
Registration and Market scenario
Top CRO’s and R and D
Drug discovery methods
Target selection
Cellular and genetic target
Genomics
Proteomics
Bioinformatics
HTS
In-vitro and in vivo studies
Clinical trials and phases of clinical phases

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Gene therapy
Orphan Drugs
1 Write about registration of newly discovered drug.
2 Explain different methods of drug discovery
3 Write about target selection of drug
4 Write about high throughput screening
5 Explain about SAR studies, in-Vivo & ex-Vivo studies
6 Write about different phases of clinical trials
7 Write a note on gene therapy
8 What are orphan drugs

Module -3 Clinical Trial Design

Clinical Trial Design Types
Cohort Study
Case Control
Cross Sectional Study
Parallel Group Design
Randomization
Bias
Blinding and Types of Blinding
Double Dummy Technique
Cross Over Study Design
Factorial Study Design
What is the difference between SAD and MAD phase?
▪ What are the importance of Phase 1, Phase 2, Phase 3, and Phase 4 ?
▪ What do you mean by SDR and SDV ?
▪ What do you mean by randomized double blinded study ?
▪ What is the full form of DCGI ?

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BridgeSang Pvt Ltd CDM Hand Book

Module 4 – Clinical Trial Management

Drugs
Pharmacokinetics
Pharmacodynamics
Effects of drugs
Therapeutic effect
Effects of drugs on body

Module 5– Clinical Research

Agenda
Informed consent process
Informed consent and vulnerable populations
Investigator's Brochure
FDA Form 1572
Confidential disclosure agreement (CDA)
Clinical trial agreement (CTA)
Investigator’s undertaking
Essential documents

Module 6 - Introduction to Clinical Data Management

Introduction to CDM
Definition, Meaning
Importance of CDM

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Objectives of CDM
CDM process
Data dictionaries
Data review and data queries

Module 7- Coding of Clinical Data and coding

management
Coding
Structure of dictionaries
Different Forms of coding
Process of coding
Coding Dictionaries
WHO DD
MedDRA
Dictionary Maintenance/Updates
Auto-coders/Auto-encoders

Module 8- Coding for adverse event

Coding of Adverse Events
Coding of Concomitant Medication

Module 9- CRF design

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BridgeSang Pvt Ltd CDM Hand Book

CRF introduction
Why CRF
Who should design CRF
Consideration in CRF Design
Standard CRF Modules
Demography
Inclusion / Exclusion
Medical History
Concomitant Medication
Adverse Events
Study Disposition
Investigator Declaration/signature

Module 10- Data Entry

Overview
Log in Fields
Data Entry Comparison Reconciliation
How to browse
The audit trial
Data Entry Using the DCI Book - Query Mode

Module 11- Data Storage and Archival

Goals of effective data storage
Types of data storage

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BridgeSang Pvt Ltd CDM Hand Book

Physical storage
Electronic storage and warehousing
Data Archival
SOP’s for Data storage & Data archival
Data migration
Problems with data storage

Module 12- Database closure

Introduction
Term used in Database lock
Interim analyses
Final Analyses
Data base closure, Preclosure checks, Approval
Safety analysis
AE Analysis
SAE Analysis
Con Med Analysis
Efficacy of Trial Medication

Module 13-Discrepancy Management

Data Inconsistencies
Discrepancy Types
Univariate discrepancies
Multivariate discrepancies
Manual Discrepancies

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BridgeSang Pvt Ltd CDM Hand Book

Key protocol violations

Consistency checks
Range Checks
Visit Sequence Checks

Useful Links :
https://www.ecfr.gov/current/title-21

ICH GCP :

2.1 Clinical trials should be conducted in accordance with the ethical principles that
have their origin in the Declaration of Helsinki, and that are consistent with GCP
and the applicable regulatory requirement(s).

2.2 Before a trial is initiated, foreseeable risks and inconveniences should be

weighed against the anticipated benefit for the individual trial subject and society.
A trial should be initiated and continued only if the anticipated benefits justify the
risks.

2.3 The rights, safety, and well-being of the trial subjects are the most important
considerations and should prevail over interests of science and society.

2.4 The available nonclinical and clinical information on an investigational product

should be adequate to support the proposed clinical trial.

2.5 Clinical trials should be scientifically sound, and described in a clear, detailed
protocol.

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2.6 A trial should be conducted in compliance with the protocol that has received
prior institutional review board (IRB)/independent ethics committee (IEC)
approval/favourable opinion.

2.7 The medical care given to, and medical decisions made on behalf of, subjects
should always be the responsibility of a qualified physician or, when appropriate,
of a qualified dentist.

2.8 Each individual involved in conducting a trial should be qualified by education,

training, and experience to perform his or her respective task(s).

2.9 Freely given informed consent should be obtained from every subject prior to
clinical trial participation.

2.10 All clinical trial information should be recorded, handled, and stored in a way
that allows its accurate reporting, interpretation and verification

ADDENDUM
This principle applies to all records referenced in this guideline, irrespective of the
type of media used.
2.11 The confidentiality of records that could identify subjects should be
protected, respecting the privacy and confidentiality rules in accordance with the
applicable regulatory requirement(s).

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2.12 Investigational products should be manufactured, handled, and stored in

accordance with applicable good manufacturing practice (GMP). They should be
used in accordance with the approved protocol.

2.13 Systems with procedures that assure the quality of every aspect of the trial
should be implemented.

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