3. Keywords for Clinical
trial
01
02
Experimental
Unit
Treatment &
Evaluation
An experimental unit is usually referred
to as a subject from a targeted
population under study .
To analysis a result of study.
Experimental Unit
In clinical trials a treatment can be a
placebo or any combinations of a new
pharmaceutical identity (e.g., a
compound or drug), a new diet, a surgical
procedure, a diagnostic test, a medial
device, a health education program, or
no treatment.
Evaluation of effectiveness and safety
of the test treatment and all activities
belongs to human begin
Like cost , quality of life , genetic factor
Treatment and Evaluation
4. Approach of clinical trial
1.Principal
Investigator
2. Drug Feasibility
3. Possibility to
check all data &
Information
Trial
Approach
1.CDA from PI
2. PI Approach
the Protocol to
EC
Feasibility
Questionnaire
& Sponsor
Protocol
Ethics
committee
Protocol, Safety,
PI Eligible, Site
checking , lab
facility, Molecule
/ dosage, QT
checking , ICF ,
INSURANCE
If EC approval
letter get, START
CT. before get
approval from
CTRI
EC Approval
Letter
After register
CTRI get
approval to start
CT
Approval from
CTRI
5. SMO – Site Management Organization
TO
1.To conduct a Clinical trial by
initiation of PRINCIPLE
INVESTIGATOR’S drug
2. Protocol development
1.A Person that is retained as an
independent contractor of the
principle investigator
2.A CRO may perform SMO function
3.Research site to provide
administrative support of the conduct
study, such as recruitment of
subjects, collection and prepare
study data like all.
. To check all the data about
the drug molecule details and
ADHERSE EVENTS
SMO
To check the new drug
feasibility and all the
information about that drug
6. Feasibility Questionnaire's and Sponsor Protocol
In the feasibility
questionnaire belongs
to all question about
the PI details and site
tracking details.
2. Feasibility
Questionnaire
3. Details about PI
experience in
clinical trials
CDA is deals with
Sponsor and PI
1. Confidentiality
Disclosure Agreement
4. PI approach the
study to Ethics
committee
7. Ethics Committee
An IRB/IEC review the appropriateness of the clinical trial protocol as well as
the risks and benefits of the study participants.
A committee of physicians, statisticians, researchers, community advocates,
and others that ensures that a clinical trial is ethical and that the rights of
study participants are protected
EC is mainly formed to find the safety of subjects
1.Protocol
2. Safety
3. PI Eligibility
4. Site Checking
5. Lab facility
6. Staff eligibility
7. Clinical
research staff
8. Molecule /
dosage data
9. QT checking
10. ICF
11. Insurance
8. EC Approval & CTRI Registry
4. To register the CTRI
with all documents
properly
2. Another important flow
of study was to register
the CTRI
3. Without the CTRI
approval letter, study can
start. Because the EC
approval letter was
enough to start the study
1. If EC approves the study
after the committee
discussion, Approval
letter was issued to
start the study
9. ICF & Screening
ICF was furnished about
all the details about the
study.
Include the pre clinical
trial details also.
ICF and Screening
Screening
Before enroll the patient, to find the
history of that health status and
personal approval
Before the patient enrollment, PI wants to explain
all the risks and benefits about the study .
All details are cleared and if patient was willing to
participate means get sign from ICF
And also explain about the AE and
cleared all the details in ICF
10. Randomization
Another one was TREATMENT GROUP +
( STANDARD + PLACEBO)
PLACEBO – Which is identical to new
drug but does not contain active
ingredient
Single blind and double blind study
Randomization
Computer to randomized a
patient whether an treatment group or
Control group
B
Control group
Standard
Standard treatment
only
Standard
New drug
Treatment Group
A
11. After Randomization
End of the visit has to taken all
the lab test for the safety
procedure
End of the visit
In these section was
performed by analysis of all
clinical data and move to
CDSCO for further more
process
Analysis and Marketing
Follow up of subject was a
challenge task
And it should note all data
and fill the logs and CRF
Follow up
Documentation is the
important procedure to
maintain the study. Which
should clear and all data was
noted
Documentation
After
Randomiza
tion
14. Clinical trial Application in India
Form 44 for clinical
trial application
04
Recent regulatory
reforms initiated by
CDSCO
05
1. Fast-tracking approval timelines
2. Single-window clearance for export No
Objection Certificate (NOC)
3. Mandatory registration with Clinical
Trials Registry- India (CTRI)
Drug and cosmetic act, 1945 &
Schedule Y
01
Regulatory Requirement for
clinical trial 02
Flow of application for
clinical trial
03
15. Drug and Cosmetic Act ,1945 & Schedule Y
The history of various regulatory aspects related to
drug import, manufacture and sale are covered under
the Drugs & Cosmetics Act of 1940 and Drugs &
Cosmetics Rules of 1945
The Act’s main objective is to ensure that available human
drugs are safe and efficacious and conform to prescribed
quality standards, and marketed cosmetics are safe for use.
Currently clinical trials in India are regulated by
Schedule Y of the Drug and Cosmetics Rules, 1945.
Schedule Y defines the requirements and guidelines for
import and/or manufacture of new drugs for sale or for
clinical trials which is governed by CDSCO(Central Drug
Standard Control Organization).
A
B
C
D
16. Regulatory requirement for clinical trial
Regulatory processes are being harmonized
with US and international standards.
Drugs Controller General of India(DCGI) has the prominent role
in overseeing clinical trial in India along with Ethics committee
(IEC/IRB: Institutional Ethical Committee/Institutional Review
Board).
Apart from DCGI, different agencies such as
Department of Biotechnology (DBT)
Indian Council of Medical Research (ICMR)
Central Bureau of Narcotics (CBN)
Review Committee on Genetic Manipulation
(RCGM)
Genetic Engineering Approval Committee
(GEAC)
are involved in clinical research regulation in
India.
Regulatory
Body for
clinical Trial
17. Flow of Application for Clinical Trial
Primary permission for clinical trial
Importing drug for clinical trial
Sponsor should provide all data regarding drug
molecule
Applicant has to submit all Suspected or
Unexpected Serious Adverse Reactions (SUSAR) if
any.
Sponsor has to submit affidavit stating that study has
not been discontinued in any country(If any reason
should be provided)
Approval time of application in India is 10-12 weeks
A
B
C
D
18. Institutional Ethics
Committee / Review
Board
IEC / IRB
IEC / IRB
In case of BA/BE study for new drug,
the anticipated timelines for DCG(I)
approval would be 6-8 weeks.
For the BA/BE study, the regulatory
requirement for the study depends upon
the study drug molecule.
Approval process is conducted in
parallel with DCGI.
If the study drug molecule is old drug,
then approval from the DCG(I) won’t be
required and only the approval from the
EC committee will suffice.
19. Form 44 for CT application:
Application for permission to initiate specific phase of clinical trial sponsor is
required to submit application (Form 44 and Appendix-01) for the purpose of conducting
clinical trial in India and submit documents as per Schedule Y of the Drugs and Cosmetics
Act 1940 and Rules.
FORM 44:
• Form 44 is an application for grant of permission to undertake for conducting Clinical
Trial.
• The document design is as per the International submission requirements of Common
Technical Document (CTD) and has five Modules.
Module 1: Administrative / Legal Information
Module 2: Summaries
Module 3: Quality Information ( Chemical, Pharmaceutical, Biological )
Module 4: Non- Clinical Information
Module 5: Clinical information
20. • A clinical trial application utilizes Form 44, accompanied by documents.
– Chemical and pharmaceutical information,
– Animal pharmacology,
– Toxicology data,
– Clinical pharmacology data.
• Other trial-related documents that must be submitted for approval include the
– Investigator’s Brochure,
– Trial protocol, amendments
– Case report form,
– Informed consent form,
– Investigator’s undertaking.
– Trial’s regulatory status of the trial in other countries must be reported.
21. Recent regulatory reforms initiated by CDSCO:
Fast-tracking approval timelines:
• If the application is complete, first response from the DCGI office can now be expected
within 30 days.
Single-window clearance for export No Objection Certificate (NOC):
• Earlier, after obtaining permission from the DCGI for conducting a trial, an applicant had to
apply separately to the Directorate General of Foreign Trade (DGFT) for an export NOC. This
process has now been simplified and fast tracked, so that an applicant can apply for trial
permission as well as export NOC to DCGI, without the need for a separate application to
DGFT.
• As per revised timelines, export NOC can now be expected within 10 working days, in
contrast to the previous 2-4 weeks timeline for DGFT approval
22. Mandatory registration with Clinical Trials Registry-India (CTRI):
• The National Clinical Trial Registry (www.ctri.in) launched by National
Institute of Medical Statistics (NIMS) under the Indian Council of Medical
Research (ICMR) has been operative for the last two years.
• CTRI ensures accountability and transparency in conducting trials that are the
two essential demands of globalisation.
23. IMPORTANCE OF THE ESSENTIAL DOCUMENTS FOR THE CONDUCT OF
A CLINICAL TRIAL
• Essential documents are important for:
– Evaluation of the conduct of a trial and the quality of data produced
– Successful management of the trial by the investigator, sponsor and
monitor
– Validation by regulatory authority(ies) and sponsor’s audits
• Depending on the stage of the trial, essential documents are grouped in three
sections:
– before the start of clinical trial
– during the conduct of the trial
– after the completion or termination of the trial
24. ESSENTIAL DOCUMENTS THAT A MEDICAL WRITER SHOULD KNOW
A medical writer must know about the following essential documents that are required
during a clinical trial
