In this PPT I have discussed : How to Register a clinical Trial in india

1. CLINICAL TRIALS REGISTRY- INDIA(CTRI)
–How to register a clinical trial
Dr Rahul Saini
Assistant Professor
Department of Pharmacology
BPS Govt Medical college khanpur,sonipat

2. Introduction
 In a clinical trial, participants receive specific interventions
according to the protocol
These interventions may be :
 Medical products(Drugs or devices; procedures)
 Life style changes (Dietary )
 Clinical trials may compare a these intervention to :
 Standard
 Other
 Placebo
 The investigators try to determine the safety and efficacy
of the intervention by measuring :Outcomes in the
participants

3.  Clinical trials have potential for
Benefiting patients
Improving therapeutic regimens
 Ensuring advancement /New treatment ( Evidence based
medicine)
Unfortunately, the data and reports of various trials :Difficult to
find :
 Many trials abandoned in midway
 “Negative" or equivocal results or are not published
 Resulting in biased "evidence-based medicine“.
Transparency, accountability and accessibility :feasible only if all
clinical trials conducted are registered in a centralized clinical trials
registry

4. What is the Clinical Trials Registry - India
• Clinical Trials Registry - India (CTRI) : Present at the National
Institute of Medical Statistics, ICMR, New Delhi
• Free and online system for registration all clinical trials being
conducted in India.
• Trials registered in the CTRI are freely searchable, both from the
CTRI site as well as from the International Clinical Trials Registry
Platform (ICTRP).

5. What is the International Clinical Trials Registry
Platform(ICTRP)
• The ICTRP is a network developed by the WHO.
• To ensure that a complete view of research is accessible to all
those involved in health care decision making.
• The ICTRP in itself is not a Registry, but collects data (details
of registered trials) and display them from a single search
portal.

6. Why should I register my clinical trial
• The Drugs Controller General (India) has made trial registration in
the CTRI mandatory with effect from 15th June 2009.
• Access to information about ongoing, completed and published
clinical research is needed by researchers, research funders,
policy-makers, medical practitioners, patients and the general
public to make treatment decisions.
• World Medical Association, in its revision of the Declaration of
Helsinki ,specifies that "Every clinical trial must be registered in a
publicly accessible database before recruitment of the first
subject.“
• Now many journals require submission of the trial registration
number prior to consideration of clinical trial data for publication

7. ADVANTAGES OF PG THESIS REGISTRATION IN CTRI
 Avoidance of unnecessary duplication of efforts:
 Study already been conducted & has conclusively shown
results-unethical & wasteful to repeat it.
 Source of information:
 Ideas of topics,designing etc
 Name of the guide & student as personal information
 Unbiased source of data for metaanalysis
 Overcome publication bias(tendancy of publishers to publish
only positive results

8. Which clinical trials are required to be registered
 Any research study that assigns human participants to one or more
health related intervention to evaluate the effects on health
outcomes.
 Health related interventions include any intervention used to
modify a health outcome and include drugs, surgical procedures,
devices, vaccines, herbal compounds, behavioral treatments.
 In addition, observational trials, bioavailability ,bioequivalence &
post marketing surveillance trials- Should be registered
 If Doubt :GOLDEN RULE : Go ahead and register the trial.

9. When should a clinical trial be registered
 To register all clinical trials prospectively, i.e. before
the enrollment of the first patient.
 Currently, ongoing and completed trials are also
being registered.

10. Is any payment required for registering clinical trials
or accessing/viewing registered trials
 There is no charge for registering a trial.
 Registered trials are also freely accessible to the
public.

11. How to Register
 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.
 A reference number of the trial is given by CTRI.
 CTRI checks the dataset and sends back trial modification
:incomplete/inappropriate.
 A unique registration number is provided to the trial
valid for submission of the study in any journal

12. APPLIED FOR
USERNAME &
PASSWORD
CTRI REGISTRATION PROCESS
TO ENTER DATA FIELD ONLINE & CAN BE SAVED
SUBMISSION OF FORM
VERIFICATION BY CTRI
CHANGES REQUIRED
REQUEST TO REGISTRANT FOR ONLINE CORRECTION
AMENDED DATA RECEIVED,EC/DCGI PERMISSION UPLOADED
SATISFACTORY
CHANGES
CHANGES
REQUIRED
COMPLETE DATA
SET
INCOMPLETE
DATA SET
TRIAL REGISTERED
FULL CTRI
NUMBER
ASSIGNED
PROVISIONAL
CTRI NUMBER
ASSIGNED

13. DCGI APPROVAL
 As per circular no 12/1/DC from CDSCO :Researchers will no
longer need the permission of the Drug Controller General of
India (DCGI) for “academic/research purposes that are non-
regulatory in nature.”
 Non Regulatory :not intended for the marketing of a new
drug.
 Ethical committee permission is mandatory
 The ethics committee is still required to inform the DCGI of
the study and the DCGI will have 30 days to object to the
decision to not seek its approval.
 In case no objection is received, permission is presumed

14. Registration Data Set of the CTRI
 Registration Number
 Trial Registration Date
 Public Title of Study*
 Scientific Title of Study*
 Secondary IDs, (UTN, Protocol No etc.)*
 Principal Investigator’s Name and Address
 Contact Person (Scientific Query/Public Query)*
 Source/s of Material or Monetary Support*
 Primary Sponsor*/ Secondary Sponsor*
Underlined items are assigned by the CTRI
software upon trial registration.

15.  Countries of Recruitment*
 Name of Ethics Committee and approval status*
 Regulatory Clearance obtained from DCGI*
 Study Type*
 Intervention and Comparator agent*
 Key inclusion/Exclusion Criteria*
 Method of generating randomization sequence
 Blinding and masking
 Target sample size*
 Phase of Trial*
 Date of first enrollment*
 Estimated duration of trial
 Brief Summary*

18. 18
www.ctri.in

19. References
• http://www.ctri.nic.in
• Sil, Amrita, and Nilay Kanti Das. “How to Register a Clinical
Trial in India?” Indian Journal of Dermatology 58.3 (2013):
235–236. PMC. Web. 10 Oct. 2017.
• Pandey A, Aggarwal A, Maulik, M, Seth SD. Clinical trial
registration gains momentum in India. Indian J Med Res
[Letter to Editor] 2009; 130: 85-86.