A Dummy’s Checklist for Clinical Trial Global Institute of Regulatory Affairs

ISBN - 978-81-909281-0-6 Price – Rs 595-/- (India Circulation)

Editor:
Rajkumar M Gupta
M Pharm, University of Mumbai, India, 30 Years Industry
Experience
MD & Founder of Perfect Pharmaceutical Consultants Pvt
Ltd & GIRA

Author:
Arti R Gupta
B Pharm, University of Pune, India
PGDRA , GIRA.

Outline: Provides a detailed list of all the parameters

associated with initiation, continuation and close-out of trials.
The checklist can be used to validate proper planning and
execution of upcoming clinical trials. It can also be used for
evaluation of the trial which have been closed-up recently

Readership
Clinical Research Students, Academics in Pharmaceutical
Science, Researchers, Investigators, Biostatistician, QC/QA
Pharmacists, Volunteers, Physicians and Government officials associated with Clinical Trials.

Contents:
• Checklist for registration of clinical trial.
• Checklist for clinical trial protocol.
• Checklist for pre-trial monitoring.
• Checklist for controlling investigational Product.
A Dummy’s Checklist for Clinical Trial Global Institute of Regulatory Affairs
ISBN - 978-81-909281-0-6 Price – Rs 595-/- (India Circulation)

• Checklist for case report form.

• Checklist for informed consent form.
• Checklist for investigator brochure.
• Checklist for selection of site for clinical trial.
• Checklist for appointing an investigator.
• Checklist for registering the subjects.
• Adverse event reporting form.
• Checklist for interim/ annual report.
• Checklist for safe data handling.
• Checklist for essential documents.
• Checklist for termination of clinical trial.

Description: Checklists are used to reduce the risk of failure in complex situation and jobs. They
help to see a task is completed to the fullest and efficiency in doing the same is increased.

Checklists are growingly used in Medical Science field, by physicians, doctors, Clinical trial
investigator, QA personnel to reduce risk and improve efficiency.

Clinical Trials are conducted to test the safety and efficacy of drug for human use. In the process
of conducting the clinical trial human life is directly involved as they act as subject and deviation
have no scope on such a process. Hence checklist prove vital to reduce and deviation and
completion of the trial to the fullest possible.

The book A Dummys Checklist to Clinical Trial provides detailed list of all the parameters
associated with initiation, continuation and close-out of trials. The checklist can be used to
validate proper planning and execution of upcoming clinical trials. It can also be used for
evaluation of the trial which have been closed-up recently

The Checklist can be used as a starting point by researchers, Investigators, Biostatistician,

QC/QA Pharmacists, Volunteers, Physicians and Government officials associated with Clinical
Trials.

Students studying Clinical Trials can be used this as a study material to gain insight on the
necessary parameters of Clinical trials.

This checklist also covers registration of Clinical Trial in India.

How to Order ?
A Dummy’s Checklist for Clinical Trial Global Institute of Regulatory Affairs
ISBN - 978-81-909281-0-6 Price – Rs 595-/- (India Circulation)

For Indian Circulation Only.

1) Prepare a Cheque/Demand Draft /Pay Order for Rs 595-/- in favour of Global Institute of
Regulatory Affairs.
2) All Demand Daft/cheque/Pay Order payable at Pune.
3) Send the same at the below mentioned address with dispatch address.
4) All Queries in regards to book can be sent at
a. Email- info@regulatoryinstitute.com
b. Fax- 020-27481048

Attn: Sumit Gupta

Global Institute of Regulatory Affairs

Empire Estate, Shop NO C 5 & 6,
Mumbai Pune Highway,
Chinchwad Pune – 19
Tele – 020-46704472
Mob- +91 9890512558
Website – www.regulatoryinstitute.com
Email- info@regulatoryinstitute.com

For International Orders please email at the above address for pricing and shipping
information.

Brief on Global Institute of Regulatory Affairs ( Publisher )

GIRA is a Division of “Perfect Pharmaceutical Consultants Pvt Ltd” providing training in the
field of regulatory Affairs to students and pharma professionals.

Today GIRA has a wide students base which consist of both Indian and International students
taking part in GIRAs Distance learning programs and Class Room Programs located in Pune.