A Practical Guide to Human Research and Clinical Trials


Regulatory bodies such as the European Medicine Agency have done tremendous work in collaboration with experts from the field to develop Good Clinical Practices that apply not only in Europe but also in emerging countries. Designed to be a teaching aid and reference guide, A Practical Guide to Human Research and Clinical focuses on ethics, regulations, and guidelines.

Conducting a successful clinical trial requires not only a strong basic knowledge, but also hands-on practical ...

See more details below
Hardcover (Reprint)
BN.com price
(Save 7%)$145.95 List Price
Other sellers (Hardcover)
  • All (6) from $117.65   
  • New (4) from $117.65   
  • Used (2) from $135.51   
Sending request ...


Regulatory bodies such as the European Medicine Agency have done tremendous work in collaboration with experts from the field to develop Good Clinical Practices that apply not only in Europe but also in emerging countries. Designed to be a teaching aid and reference guide, A Practical Guide to Human Research and Clinical focuses on ethics, regulations, and guidelines.

Conducting a successful clinical trial requires not only a strong basic knowledge, but also hands-on practical training. The book explains the intricate details of the subject to readers by citing concrete cases, exercises, and templates along with the theoretical aspects. Prof. M.U.R Naidu and his co-authors address all aspects of clinical trials from clinical research, drug development, and quality to methodology, biostatistics, and pharmacovigilance.

Read More Show Less

Product Details

  • ISBN-13: 9781466591172
  • Publisher: Taylor & Francis
  • Publication date: 2/1/2013
  • Edition description: Reprint
  • Pages: 350
  • Product dimensions: 6.40 (w) x 9.80 (h) x 1.00 (d)

Table of Contents

Clinical Research – A Clinical Investigator’s Perspective
Scientific and Practical Aspects
Financial Considerations

Medical Device Development, Process and Regulation
Categories of Medical Devices
Evaluation of Medical Devices
Regulatory Process

Pre-Clinical Drug Development
Overview of Drug Discovery and Role of basic Sciences
New Approaches in Drug Discovery
Pharmacological Screening

Phases of Clinical Trials
Phase I
Phase II Studies
Phase III Trials
Phase IV Trials

Phase 0 - Microdosing Studies
Micro-dosing and Exploratory-IND Studies
Characteristics of an Ideal Candidate Drug for Phase 0-Micro-dosing Studies
Goals of Microdosing Studies
Technical Advances
Regulatory Issues
Patient’s Perspective
Informed Consent Issues
Single-dose Toxicity Study in Support of Micro-dosing Studies
Advantages of Micro-dosing
Limitations of Micro-dosing

Clinical Research Planning
Introduction to Clinical Trials
Types of Clinical Trials
The Planning Steps

Clinical Research Design
Elements of Trial Design
Types of Clinical Trial Design

Clinical Research Protocol
Title Page
Signature Page
Contents Page
List of Abbreviations and Definitions
Trial Objectives and Purpose
Study Design
Subject Selection
Subject Recruitment
Trial Interventions
Statistical Considerations
Compliance and Withdrawal
Interim Analysis and Data Monitoring
Ethical Considerations
Financing and Insurance
Reporting and Publication

Designing Case Report Forms
Uses of CRF
Well-Designed CRF
CRF Design Layout
CRF Field Designs
CRF Verification Before Use
Elements of Trial Design
Electronic Data Entry Forms
Points to Remember

Process of Randomization in Clinical Trials
Advantages of Randomization
Types of Randomization
Techniques of Randomisation
Implementation of Randomization Procedure

Investigational Medicinal Products
Manufacturing, Packaging, Labeling, and Coding IMPs
Supply and Handling IMPs
Receipt of IMP, Inventory, Storage and Accountability
Randomization Code
Principles Applicable to Comparator Product
Blinding Operations
Recall, Return, Shipment and Destruction of IMP

Multi-center Clinical Trials
Advantages and Disadvantages
A Common Protocol
A Coordinating Centre
Comparability of Participating institutions
Committees in a Multi-center Trial
Statistical Issues
Analysis of Results
Multinational Clinical Trials

Good Clinical Research Practice
Definition of GCP
Overview of the Clinical Research Process
Principles of GCP

Role and Responsibilities of Sponsor
Contract Research Organization (CRO)
The Sponsor and the investigational Products
Sponsor and Record Access
Safety Information

Role and Responsibilities of Principal Investigator
Competencies and Responsibilities of the Principal Investigator
Qualifications and Availability
Adequate Resources
Informed Consent
Investigational Products
Compliance with Protocol
Monitoring and Auditing
Source Data and Other Documentation
Safety Issues and Reporting of Serious Adverse Events
Premature Termination - Breaking the Treatment Code
Progress Reports, Trial Outcome and Final Study Reports

Ethical Consideration in Clinical Research – Special Reference to Developing Countries
Individuals Involved With Ethical Issues
Ethical Issues Related to Protocol Development and Study Design
Issues on Informed Consent
Ethical Issues During Conduct of a Clinical Research
Access to Post Trial Benefits
Need for Developed Countries to Assist Developing
Countries in Capacity Building

Informed Consent in Clinical Research
Historical Background
Elements of Informed Consent
Language Used in Consent Forms
Informed Consent Waiver
Revising an Informed Consent
Reconsenting Process
Consent Obtained from Special Groups of Patients

Monitoring in Clinical Trials
Types of Monitoring in Clinical Trials
Key Participant in Monitoring of Clinical Trial

Quality Assurance in Clinical Research
Monitoring-Details Presented in Chapter on Monitoring
Data Management Metrics

Pharmacovigilance and Drug Safety
Terms Commonly Used in Drug Safety
The Specific Aims of Pharmacovigilance
ADR Classification and Evolution
Causality Assessment Scales
Important of Post Marketing Surveillance and ADR Reporting
Characteristics of a Good Adverse Drug Reaction Report
Periodic Safety Update Report (PSUR)
MedDRA or Medical Dictionary for Regulatory Activities
Pharmacovigilance in India

Data and Safety Monitoring Board and Monitoring Plan
Definition and Purpose
Data Monitoring Committee
Data Safety Monitoring Plan

Standard Operating Procedures
Standard Operating Procedures
SOP Template
Master Formulation Record

Archiving Clinical Research Documents
Stake Holders
What Documents Must Be Archived
How long Should the Documents be Archived
When to Archive Trail Master File (TMF)
The Archive Building

Evidence Based Medicine
Introduction and Overview
Types of EBM
Categories of Evidence
Categories of Recommendations
Statistical Measures
Quality of Clinical Trial Publications
Limitations of Available Evidence
Criticism of Evidence-Based Medicine

Clinical Research Data Management
Data Management
Final Study Report
Retension and Securing of Records
Archiving by the Principle Investigator
Archiving by the Sponsor

Clinical Biostatistics
(a) Biostatistics for Clinical Researcher
26(a).1 Introduction
26(a).2 Descriptive Statistics
26(a).3 Null Hypothesis and Alternative Hypothesis
26(a).4 Classifications of Data
26(a).5 Test of Hypothesis with the Correct Statistical Tests
26(a).6 Summary
(b) Terminology Used in Biostatistics
26(b).1 Introduction to Biostatistics
26(b).2 Terminology used in Biostatistics
26(b).3 Sampling Unit


Read More Show Less

Customer Reviews

Be the first to write a review
( 0 )
Rating Distribution

5 Star


4 Star


3 Star


2 Star


1 Star


Your Rating:

Your Name: Create a Pen Name or

Barnes & Noble.com Review Rules

Our reader reviews allow you to share your comments on titles you liked, or didn't, with others. By submitting an online review, you are representing to Barnes & Noble.com that all information contained in your review is original and accurate in all respects, and that the submission of such content by you and the posting of such content by Barnes & Noble.com does not and will not violate the rights of any third party. Please follow the rules below to help ensure that your review can be posted.

Reviews by Our Customers Under the Age of 13

We highly value and respect everyone's opinion concerning the titles we offer. However, we cannot allow persons under the age of 13 to have accounts at BN.com or to post customer reviews. Please see our Terms of Use for more details.

What to exclude from your review:

Please do not write about reviews, commentary, or information posted on the product page. If you see any errors in the information on the product page, please send us an email.

Reviews should not contain any of the following:

  • - HTML tags, profanity, obscenities, vulgarities, or comments that defame anyone
  • - Time-sensitive information such as tour dates, signings, lectures, etc.
  • - Single-word reviews. Other people will read your review to discover why you liked or didn't like the title. Be descriptive.
  • - Comments focusing on the author or that may ruin the ending for others
  • - Phone numbers, addresses, URLs
  • - Pricing and availability information or alternative ordering information
  • - Advertisements or commercial solicitation


  • - By submitting a review, you grant to Barnes & Noble.com and its sublicensees the royalty-free, perpetual, irrevocable right and license to use the review in accordance with the Barnes & Noble.com Terms of Use.
  • - Barnes & Noble.com reserves the right not to post any review -- particularly those that do not follow the terms and conditions of these Rules. Barnes & Noble.com also reserves the right to remove any review at any time without notice.
  • - See Terms of Use for other conditions and disclaimers.
Search for Products You'd Like to Recommend

Recommend other products that relate to your review. Just search for them below and share!

Create a Pen Name

Your Pen Name is your unique identity on BN.com. It will appear on the reviews you write and other website activities. Your Pen Name cannot be edited, changed or deleted once submitted.

Your Pen Name can be any combination of alphanumeric characters (plus - and _), and must be at least two characters long.

Continue Anonymously

    If you find inappropriate content, please report it to Barnes & Noble
    Why is this product inappropriate?
    Comments (optional)