The document provides information on various aspects of clinical trials including: - The different phases of clinical trials from Phase 0 to Phase V - Key elements of a clinical trial protocol such as objectives, design, and methodology - Regulatory requirements for conducting clinical trials including compliance with ICH GCP guidelines - Common recruitment strategies and important documents required for clinical trial authorization applications such as the clinical trial protocol, investigator brochure, and informed consent forms.

1. .

2.  Gain a comprehensive overview of the
regulatory requirements for carrying out
clinical trials
 Ensure compliance in regulatory requirements
for investigational medicinal products,
pharmacovigilance, and Clinical Trial Data
Management including EDC and e-source
 Explore recent developments in clinical trial
regulations including FDA requirements
 Achieve successful regulatory inspections.

3.  Clinical research is the key to the discovery
of latest diagnostic methods and to
develop modern drugs for treatment of
diseases. Good Clinical Practices (GCP) is
an ethical and scientific quality standard
for designing, conducting and recording
trials that involve the participation of
human subjects.

4.  A clinical trial protocol is a document that
describes the objective(s), design,
methodology, statistical considerations,
and organization of a clinical trial
 A clinical trial protocol is a document used
to gain confirmation of the trial design by a
panel of experts and adherence by all
study investigators, even if conducted in
various countries.

5.  It involves in vitro(test tube or cell culture)
and in vivo(animal) experiments using wide
ranging doses of the study drug to obtain
preliminary efficacy, toxicity and
pharmacokinetics information.

6.  Clinical trials involving new drugs are
commonly classified into four phases.
 1-Phase 0:- is a recent designation for
exploratory, first in human trial conducted in
accordance with the USFDA 2006 Guidance on
Exploratory IND Studies.
 Phase I:- trials are the first stage of testing in
human subjects. Normally, a small (20-100)
group of healthy volunteers will be selected.
This phase includes trials designed to assess
the safety (pharmacovigilance), tolerability,
pharmacokinetics, and pharmacodynamics of
a drug.

7.  Phase II:- Once the initial safety of the study
drug has been confirmed in Phase I trials,
Phase II trials are performed on larger groups
(100-300) and are designed to assess how well
the drug works, as well as to continue Phase I
safety assessments in a larger group of
volunteers and patients.
 Phase III:- studies are randomized controlled
multicenter trials on large patient groups (300–
3,000 or more depending upon the
disease/medical condition studied) and are
aimed at being the definitive assessment of
how effective the drug is, in comparison with
current 'gold standard' treatment.

8.  Phase IV :-trial is also known as Post
marketing surveillance Trial. Phase IV trials
involve the safety surveillance
(pharmacovigilance) and ongoing technical
support of a drug after it receives
permission to be sold.
 Phase V:- is a growing term used in the
literature of translational research to refer
to comparative effectiveness research and
community-based research; it is used to
signify the integration of a new clinical
treatment into widespread public health
practice.

9.  Clinical trials designed by a local
investigator and (in the U.S.) federally
funded clinical trials are almost always
administered by the researcher who
designed the study and applied for the
grant.
 Phase III and Phase IV clinical trials of new
drugs are usually administered by a
contract research organization (CRO) hired
by the sponsoring company.

10.  If a clinical trial concerns a new regulated
drug or medical device (or an existing drug
for a new purpose), the appropriate
regulatory agency for each country where
the sponsor wishes to sell the drug or
device is supposed to review all study data
before allowing the drug/device to proceed
to the next phase, or to be marketed.

11.  Depending on the kind of participants
required, sponsors of clinical trials use
various recruitment strategies, including
patient databases, newspaper and radio
advertisements, flyers, posters in places
the patients might go (such as doctor's
offices), and personal recruitment of
patients by investigators.

13.  The clinical trial sponsor is required to
submit application (Form 44) for the
purpose of conducting clinical trial in India
and submit documents as per Schedule Y
of the Drugs and Cosmetics Act 1940 .
 Good Clinical Practice Guidelines issued by
CDSCO, Directorate General of Health
Services, Govt. of India

14.  Hard copies:- It must be well labeled with
document number, name of the firm, date
of submission etc.
 Soft Copies:- They must be well labeled
with document number, name of the firm,
date of submission etc. Scanned copies of
only signed document like test reports will
be acceptable as soft copies.

15.  Introduction about Company
 Administrative Headquarters
 Manufacturing Facilities
 Regulatory permissions/approvals
 Regulatory and intellectual property status
in other countries
 Patent information status in India & other
countries

16.  Product Description
 Product Development
 Information on Drug Substance
 Production of Drug substance
 Characterization of Drug substance
 Information on Drug Product.
 - Description & composition
 Components of Drug product
 Equipment and Premises

17.  India now participates in over 7% of all
global Phase III and 3.2% of all global
Phase II trials1.
 Clinical trial outsourcing market in India is
forecast to grow at a compound annual
growth rate of over 30% during 2010-2012
to around $600 million by 2012.


18.  Three copies of the application are required:
An archival copy, a review copy, and a field
copy. An application for a new chemical
entity will generally contain an application
form, an index, a summary, five or six
technical sections, case report tabulations
of patient data, case report forms, drug
samples, and labeling, including, if
applicable, any Medication Guide required

19.  Investigational New Drug Application:-
clinical investigation is not permitted to
proceed without the prior written
authorization from FDA. FDA shall provide a
written determination 30 days after FDA
receives the IND or earlier.
 Responsibilities of Sponsors and
Investigators

20.  clinical investigations regulated by the
Food and Drug Administration. as well as
clinical investigations that support
applications for research or marketing
permits for products regulated by the Food
and Drug Administration
 Each IRB shall have at least five members,

21.  Responsibilities.
 Composition, Functions and Operations.
 Procedures.
 Records.

22.  General Information
 Background Information
 Trial Objectives and Purpose
 Trial Design
 Selection and Withdrawal of Subjects
 Treatment of Subjects
 Assessment of Efficacy
 Direct Access to Source Data/Documents
 Quality Control and Quality Assurance
 Data Handling and Record Keeping

23.  Request for authorization, applicable
timelines, authorization
 Interface with other authorization
requirements
 Cover letter
 Clinical trial application form
 Protocol
 Investigator’s brochure

24.  Ethics Committee shall give an opinion
within a maximum of 35 days of the date of
receipt of the proposed amendment in
good and due form. If this opinion is
unfavorable, the sponsor may not
implement the amendment to the protocol.

25.  The sponsor has to make an end of trial
declaration when the complete trial has
ended in all Member States/third countries
concerned.
 The end of trial notification, albeit usually
submitted only subsequently to the end of
trial notification. The sponsor should
provide this summary report within one
year of the end of the complete trial for
non-paediatric clinical trials.

26.  Bleichner G et al (1986) work on Frequency of
infections in cirrhotic patients presenting with
acute gastrointestinal haemorrhage.
 Lamont JP et al (2003) work on A randomized
trial of valved vs nonvalved implantable ports
for vascular access.
 Bien CG et al (2004) work on An open study of
tacrolimus therapy in Rasmussen encephalitis.
 Christian G. Bien et al (2009) work on Efficacy
of Tacrolimus and I.V.-
 Mouterde G et al (2010) work on Indications of
glucocorticoids in early arthritis and
rheumatoid arthritis

27.  Likosky DS et al (2010) work on The effect
of the preoperative blood transfusion and
blood conservation in cardiac surgery .
 Robertson D et al (2010) work on SOGC
clinical practice guidelines.
 Flint HE et al (2010) work on How well do
reports of clinical trials in the orthodontic .
 Carson G et al (2010) work on Alcohol use
and pregnancy consensus clinical
guidelines.
 Tolmie EP et al (2011) work on Clinical
Trials: Minimising source data queries to
streamline endpoint adjudication in a large
multi-national trial.

28.  Welch RW et al (2011) work on There is
substantial evidence to link what we eat to the
reduction of the risk of major chronic diseases
and/or the improvement of functions.
 Parsons NR et al (2011) work on A systematic
survey of the quality of research reporting in
general orthopaedic journals.
 Wong S et al (2011) work on SOGC clinical
practice guidelines: Substance use in
pregnancy.
 Nankervis H et al (2011) work on Mapping
randomized controlled trials of treatments for
eczema.

29.  International Phase I clinical trials with new
chemical entities developed in a foreign
country (first-in-human trials) are not
allowed in India.
 prevent the fake clinical trial in India
because the fake clinical trial is real
problem occur.
 It should less time taken of the clinical trial
approval in India.
 It should be inspected by drug controller
government of India.

30.  Brief Study about clinical trial Guideline.
 Comparison for Guideline of various
country.
 How possible variation in clinical trial
guideline in India.
 Study about spurious clinical trial in India
 How possible to stop fake clinical trial in
India .
 find out the literature survey.

31.  After comprehensive study of the USFDA
and ICH guideline I will find out the some
differences like as;
 International Conference on Harmonization
(ICH) Guideline covering the conduct of
clinical research studies in the seven
member nations. Guidelines represent the
agency's current thinking on Good Clinical
Practices, but do not bind the FDA or the
public.

32.  IRB:-ICH requires that the clinical
investigator provide the Institutional
Review Board (IRB) with a copy of the
Investigator Brochure (4.4.2). FDA only
requires that the pharmaceutical company
sponsor provide it to the investigator.
 Documentation of Protocol Deviations:-ICH
requires that the investigator document
and explain any deviation from the study
protocol (4.5.3). FDA does not address this
issue.
 Informed Consent:-The elements differ
between ICH (4.8.10) and FDA (50.25a,
50.25b).

33.  Financial Records:-
 Signed Protocols:-
 Indemnification:-
 Case Report Form Changes:-

34.  .