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CTRI PPT Shodh.

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148 views17 pages

CTRI PPT Shodh.

Uploaded by

sanjana
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© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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CLINICAL TRIALS

REGISTRY-INDIA
M E N KA S I N G H
T RA N E E E X E C U T I V E S
S H O D H C L I N I C A L S O LU T I O N S L L P
CLINICAL TRIAL
Any investigation in human subjects intended to discover or verify the clinical, pharmacological
and/or other pharmacodynamic effects of an investigational product, and/or to identify any
adverse reactions to an investigational product, and/or to study absorption, distribution,
metabolism and excretion of an investigational product with the object of ascertaining its safety
and/or efficacy is known as Clinical Trial.
CLINICAL TRIALS REGISTRY -INDIA

The Clinical Trial Registry of India (CTRI) – is an online system developed by National Institute of
Medical Statistics, under Indian Council for Medical Research (ICMR), New Delhi.
 The Clinical Trials Registry – India (CTRI), is a free, searchable online platform for registration of
clinical trials being conducted in India and as well as countries which do not have a Primary Registry
of their own.
 The registered trials are freely searchable not only through CTRI but also from the International
Clinical Trials Registry Platform (ICTRP).
 At present the Government of India has made registration of Clinical trials in this CTRI registry as
mandatory and is notified by Drug Controller General of India (DCGI).
The CTRI undertakes only prospective registration i.e .registration of clinical studies which have not
yet begun patient enrollment.
CONTINUED
It is a free and online public record system for registration of clinical trials being conducted in INDIA.
It was launched on 20 July ,2007 initiated as a voluntary measure, since 15th June 2009
Trial registration in the CTRI has been made mandatory by the Drug Controller General India.
Currently, the CTRI registers all types of clinical studies including
interventional trials (73%),
observational (24%),
bioavailability/bioequivalence,
post marketing surveillance studies (3%).
All registered trials are freely searchable and viewable by the public from the CTRI homepage using
appropriate and relevant keywords.
OBJECTIVE,MISSION & VISION OF CTRI

Objective of CTRI:
The main objective of this CTRI is to ensure transparency, accountability and accessibility of all
the clinical trials that are being conducted in India.
 Mission of CTRI:
The mission of CTRI is to encourage all clinical trials conducted in India to be prospectively
registered. i.e. before the enrollment of first participant.
 Vision of CTRI:
The vision of CTRI is to ensure every clinical trial conducted in the region is prospectively
registered with full disclosure of the trial data set times. Though this register is primarily meant
for trials conducted in India, the CTRI will also accept registration of trials conducted in other
countries in the region, which do not have a primary registry of its own .
WHAT SHOULD REGISTER?
All trials conducted in India, randomized or not, involving human participants, of any
intervention such as drugs (already in the market or otherwise), surgical procedures, preventive
measures, lifestyle modifications, devices, educational or behavioral treatment, rehabilitation
strategies, as well as trials being conducted in the purview of the Department of Ayurveda, Yoga
and Naturopathy, Unani, Siddha, and Homeopathy (AYUSH) (http://indianmedicine.nic.in/) are
expected to register.
Clinical trials undertaken by postgraduate students for their thesis should be also registered, as
it facilitates publication. There is a separate section dedicated to postgraduate thesis in the CTRI
website.
The golden words are “When in doubt, better register.”
DOCUMENTS REQUIRED
For a Clinical trial ,Ethical Committee Approval Certificate is mandatory.

If your study is involving any drug , then a submission of approval from the DCGI is also
necessary.
WHY IS TRIAL REGISTRATION IMPORTANT
?

Prevent selective reporting and publication of positive results


Prevent unnecessary duplication of research efforts
 Empower patients and the public about planned or ongoing trials and if necessary enroll in them.
 Give ethics committees and researchers access to studies being conducted and compare them to
research that is under their consideration or is being planned
Increases transparency and accountability
Improves internal validity of the trial
Increases the chance of publishing in high impact journal
A source of information for future studies
Reduces publication bias
REGISTRATION PROCESS
First login to CTRI website: www.ctri.nic.in
Register here: obtain username and password
New trial is then added using the CTRI registration: filling data set
The below dataset is submitted to CTRI.
A reference number of the trial is given by CTRI.
CTRI checks the dataset and sends back trial modification: incomplete/inappropriate.
CTRI verifies the trial from “PI, contact person of scientific and public query” (who can be the
same or different individuals)
A unique registration number is provided to the trial valid for submission of the study in any
journal
HOW TO REGISTER A TRIAL?

Trial registration in the CTRI is an online process and free of cost. The trial registration dataset of
the CTRI is given in the below picture.
 Process of trial registration is discussed in detail in the E- tutorial on the home page of CTRI.
CONTINUED
CONTINUED
CONTINUED
DATASET
Public title of the study (intended for lay public)
Scientific title of the study (as it appears in the protocol submitted for funding and ethical review)
 Acronym (if any) Secondary id (if any)
 Principal investigator name, address, contact details
 Contact person for scientific query
 Contact person for public query
 Sources of monetary and material support
 Primary sponsor
 Secondary sponsor
 Countries of recruitment
 Site(s) of study
CONTINUED
 Name of the ethics committee and approval status, scanned document of ethics committee approval (if already
approved
 Regulatory clearance from DCGI (as applicable)
 Health condition/problem studied
Study type (e.g., RCT, single arm trial, etc.)
Intervention and comparator agent
 Inclusion/exclusion criteria
 Phase of trial (I, II, III, IV, post-marketing surveillance)
 Date of first enrolment
 Estimated duration of trial
 Recruitment status of trial (recruiting/pending/temporarily suspended/completed/others)
CONTINUED
Method of generating randomization sequence
Method of allocation concealment
Blinding/masking (e.g., open labelled/participant blind/ investigator blind/outcome assessor blind, etc.)
Primary outcome(s)
Secondary outcomes
Target sample size (in India And Total)
Phase of trial (I, II, III, IV, post-marketing surveillance)
 Date of first enrolment
 Estimated duration of trial
 Recruitment status of trial (recruiting/pending/temporarily suspended/completed/others)
Brief Summary
SUMMARY
CTRI establishes an unbiased, scientific public record of clinical trials and also ensures
transparency, accountability and accessibility of clinical trials conducted.
Clinical Trial Registration is an easy process and is completely an online system. trial registration
costs nothing in monetary terms.
Registration of clinical trials also increases the internal validity of the trial and also increases the
chance of publishing in a high impact journal.
Trial Registration should be part of the routine research and should be practiced fully as a part
of good clinical practice for the benefit of the scientific and general community.

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