In 3 sentences: Clinical Trial Registry-India (CTRI) is a publicly accessible online registry of clinical trials conducted in India. It aims to increase transparency and accountability of clinical trials by requiring prospective registration of all trials conducted in India. The CTRI registration process involves 4 stages - opening an account, submitting trial details for review, addressing any queries, and updating trial status and submitting results.

1. CLINICAL TRIAL REGISTRY-
INDIA
PRESENTED BY- NISHA YADAV
MSC NURSING 1ST YEAR
NINE, PGIMER
CHANDIGARH

2. OUTLINES
• Clinical Trial- Introduction, Definition, and India scenario
• Clinical Trial Registry India- Introduction, Mission, Vision,
Access and Stages
• How to register Clinical Trial
• Datasets used in the clinical trial
• Advantages of CTRI
• Summary

3. INTRODUCTION
 Clinical trail is an ancient concept is a medical research study conducted
to find answers to health questions and is often conducted to evaluate
new medications, a combination of medications, or new ways to use
current treatments.
 They are also conducted to evaluate new tests, equipment, and
procedures for diagnosing and detecting health conditions and to find
vaccines to prevent illnesses. Before an experimental treatment can be
tested in a clinical trial, it must have shown benefit in laboratory testing,
animal research studies, or research in a small group of humans.
 Clinical trials are required to follow the same ethical and legal guidelines
as standard medical practice to protect the safety of participants.

4. CLINICAL TRIAL ?
• Any research study that prospectively assigns human participants or
groups of humans to one or more health related interventions to
evaluate the effects on health outcomes.
• Interventions-
o Drugs
o Cells and other biological products
o Surgical procedures
o Radiologic procedures
o Devices
o Behavioral treatments
o Process of care changes
o Preventive care, and others

5. Why conduct a clinical trial ??
Some of the questions answered by doing a clinical trial are:
 How helpful the treatment is?
 How does the experimental drug or new type of treatment work?
 If it works better than already existing treatment options?
 What are the side effects that occur as a result of the new
drug?
 How serious the side effects are when compared to standard
treatment options?
 Do the benefits outweigh the side effects?
 Which groups of people are most likely to benefit from the new
/ treatment

6. INDIA SCENARIO
• From 2008 and 2011, around 2,000 patients died during trials, but no ac
tion has
been taken against any pharma company or the Ethics Committee that
oversees clinical trials.
Pharmaceutical companies claimed that other deaths occurred due to
other reasons, such as patients being terminally ill or suffering side
effects from an unrelated cause.
• Drug trials in India Almost 2,000 trials in past seven years.
• Tests include drugs made by well known companies such as
Biogen Idec, Astra Zeneca and Glaxo Smith Kline.
• 288 deaths in 2008
• 637 deaths in 2009
• 668 deaths in 2010

7. CLINICAL TRIAL REGISTRY-
INDIA
Introduction
Mission
Vision
Access to CTRI
Stages of CTRI

8. INTRODUCTION
• The CTRI hosted at the ICMR, National institute of medical
statistics(NIMS), is a free and online public record system for
registration of clinical trials being conducted in India.
• It was launched on 20 July, 2017. Initiated as a voluntary
measure, since 15th June 2009, trial registration in the CTRI
has been made mandatory by the drugs controller general,
India

9. MISSION
• To encourage all clinical trials conducted in India to be
prospectively registered i.e. before the enrolment of the 1st
participant
• Trials where patient recruitment has started or even
completed are also being registered.
• Post marketing surveillance studies as well as BA/BE trials are
also expected to be registered in CTRI.

10. VISION
Improve transparency and accountability
Improve the internal validity of trials
Conform to the accepted ethical standards
Reporting of all relevant results of registered
trials

11. 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

12. WHEN SHOULD A CLINICAL TRIAL BE REGISTERED ??
To register all clinical trials prospectively i.e. before
the enrollment of the 1st patient
Currently, ongoing and completed trials are also
being registered

13. ACCESS TO CTRI
• There are 3 levels of access to CTRI
1. Public
2. Registrant
3. CTRI Administrator
• From the homepage of CTRI the public can perform a no. of functions
1. Can search the registered trials and view details of registered clinical trials
2. View and download trial registration dataset
3. Contact administrator for queries
• None of these functions require registration in CTRI
• Now we will understand how these 3 functions can be performed
• www.ctri.nic.in

14. 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

15. STAGES OF TRIAL
REGISTRATION IN CTRI
STAGE 1: Opening a new account for filling the trial dataset
STAGE 2: Trial submission to review by CTRI scientist
STAGE 3: CTRI clarifications to assign CTRI number
STAGE 4: Regular update about the trial and submission of final
brief summary

16. Part 1: Title of the study
– Public title: study title in a simple language to be understood by lay people
– Scientific title: study title as mentioned in protocol submitted for ethical committee (and DCGI) approval
or funding
Part 2: Principal investigators and contact person details
– Secondary IDs: universal trial number earlier known as UTRN may be obtained from
http://apps.who.int/trialsearch/utn.aspx
If there are no secondary IDs, nil can be selected
– Principal investigator: name official address, affiliation and designation, contact telephone and fax
numbers and email ID of PI
– Contact person(for scientific study): name, official address, affiliation and designation, email, telephone
no., fax no. and postal address and affiliation of the local person to contact for scientific queries about the
trial
– Contact person(for public study): name, official address, affiliation and designation, email address,
telephone no., fax no. and postal address of the contact who will respond to general queries including
information about current recruitment status
STAGE 1: OPENING A NEW ACCOUNT TO FILLING THE TRIAL DATA SET
After submission of the initial profile, a confirmation mail along with username and
password is sent to registered email id.
The CTRI dataset has eight parts including 28 items
Clinical Trial Registry- India Dataset Items For Trial Registration

17. Part 3: Details of funding and recruitment country
– Sources of monetary: major sources of monetary or material or infrastructural
support
– Primary sponsor: name and address of individual taking responsibility for securing
the arrangements to initiate and manage a study, in investigator initiated trials, PI is
primary sponsor
– Secondary sponsor: name and address of additional individuals/ organization if any,
that have agreed with the primary sponsor to take on responsibilities of
sponsorship
– Countries of recruitment: name of (intended) counties of participants recruitment
Part 4: Details of study approval status and health condition
– Sites of study: list all sites within India including the site address
– Name of ethics committee and approval status
– Regulatory clearance obtained from DCGI
– Health condition/ problem studied
Part 5: Details on study design
– Study type: PG thesis or not
type of trial: interventional trial, observational trial

18. Part 6: details on measures of internal validity
– Intervention and comparator agent: intervention- specific name of the interventions and the
comparator/ controls being studied. list all several separate treatments in the intervention package if
there are more than one intervention, in one line separated by commas
Comparator agent: name of the intervention, placebo or no treatment.
– Inclusion criteria: for participant selection, including age, sex, health condition and other criteria
– Exclusion criteria: for participant selection, including age, sex, health condition and other criteria
– Method of generating randomization sequence: used to generate the random allocation sequence
– Method of allocation concealment: allocation concealment methods used
– Blinding/ masking: type of blinding used in the study
Part 7: details on outcome measures and duration of the study
– Primary outcomes: main outcome used to determine the effect of the intervention in prespecified
time
– Secondary outcomes: outcomes measured at time-points of secondary interest
– Target sample size: total no. of participants that the trial plans to enroll
– Phase of trial: phases of investigation, usually applies to drug trials
– Date of first enrollment: anticipated or actual date of first enrolment of participant
– Estimated duration of trial: expected time duration of trial, starting from first enrolment to final
submission of report

19. PA R T 8 : D E TA I L S O N R E C R U I T M E N T S TAT U S A N D
S U M M A R Y
Recruitment status of trial: recruitment status of the trial separately for
global and Indian site
• Not yet recruiting
• Open to recruitment
• Closed to recruitment
• Completed
• Suspended
Publication details: details of publication if any
Brief summary: short description of the primary purpose of the protocol,
including a brief statement of the study hypothesis.

20. STAGE 2: TRIAL SUBMISSION TO REVIEW BY CTRI SCIENTISTS
 Once the trial is submitted, a ref number is assigned, but CTRI
number will show as pending. Now, the trial details are visible to both
registrants and CTRI.
After review of the trial details, CTRI seek clarifiactions/
modifications along with unlocking the respective fields for
further editing.
The trial can be resubmitted addressing all the clarifications
sought by CTRI satisfactorily.
The registrant should update CTRI regularly, regarding the trial
recruitment status, change in registrant or investigators, study
site, protocol amendments, change in contact persons and any
other change
Once the trial is completed the registrant will be asked by
CTRI to submit the final brief summary of the trial.
STAGE 3: CTRI CLARIFICATIONS/MODIFICATIONS TO ASSIGNMENT OF CTRI NUMBER
STAGE 4: REGULAR UPDATE ABOUT THE TRIAL AND SUBMISSION OF FINAL BRIEF
SUMMARY

21. To enter data field online & can be saved
Submission of form
Verification by CTRI
Changes required
Request to register for online correction
Amended data received, EC/DCGI permission uploaded
Applied for username and password
Satisfactory changes
Complete dataset
Incompete
dataset
Changes required
Trial registered
FULL CTRI
NUMBER
ASSIGNED
PROVISIONAL
CTRI NUMBER
ASSIGNED
CTRIREGISTRATIONPROCESS

22. ADVANTAGES OF CTRI
• Increases transparency and accountability
• Improves internal validity of the trial
• Increases the chance of publishing in high impact journal
• Avoid duplication of work
• A source of information for future studies
• Reduces publication bias

23. 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.

24. QUIZ TIME ?
Q1.What do you mean by prospective registration?
Q2.. How many stages are involved in registering clinical trial?
Q3. What is CTRI?

25. REFERENCES
• Clinical Trials Registry- India (CTRI) [Internet]. [cited 2020 Sept 20]. Available from:
http://ctri.nic.in/Clinicaltrials/cont.php
• Kaur S, Singh A. Nursing Research in 21st Century: clinical trials registry- India. CBS
Publishers & Distributors Pvt Ltd; 2019;185-193
• Pandey A, Aggarwal AR, Maulik M, Seth SD. Clinical Trials Registry- India: raising the
veil. Natl Med J India. Jan;23(3):187
• https://www.who.int > topics > clinical_trials. WHO | Clinical trials. World Health
Organization. Accessed on Sept 2020.