This document provides information on registering clinical trials in the Clinical Trials Registry - India (CTRI). It explains that the CTRI is a free, online system for registering all clinical trials conducted in India. Registration is mandatory per the Drugs Controller General (India) and provides transparency. The document outlines the CTRI registration process, including obtaining a username and password, entering trial details online, verification by CTRI, and being assigned a registration number. Key trial details that must be included are described.
The mission of the Clinical Trials Registry-India (CTRI) is to ensure that all clinical trials conducted in India are prospectively registered, i.e. before the enrolment of the first participant. Additionally, post-marketing surveillance studies, BA/BE studies as well as clinical studies as part of PG thesis are also expected to be registered in the CTRI. The vision of the CTRI is to ensure that every clinical trial conducted in the region is prospectively registered with full disclosure of the trial data set items. While this register is meant primarily 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, provided ethics approval (in English) is available and the study has not begun enrolling. The Clinical Trials Registry- India (CTRI), hosted at the ICMR's National Institute of Medical Statistics (http://icmr-nims.nic.in), is a free and online public record system for registration of clinical trials being conducted in India that was launched on 20th July 2007 (www.ctri.nic.in). Initiated as a voluntary measure, since 15th June 2009, trial registration in the CTRI has been made mandatory by the Drugs Controller General (India) (DCGI) (www.cdsco.nic.in). Moreover, Editors of Biomedical Journals of 11 major journals of India declared that only registered trials would be considered for publication1, 2.
Today, any researcher who plans to conduct a trial involving human participants, of any intervention such as drugs, 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 AYUSH (http://indianmedicine.nic.in/) is expected to register the trial in the CTRI before enrollment of the first participant. Trial registration involves public declaration and identification of trial investigators, sponsors, interventions, patient population etc before the enrollment of the first patient. Submission of Ethics approval and DCGI approval (if applicable) is essential for trial registration in the CTRI. Multi-country trials, where India is a participating country, which have been registered in an international registry, are also expected to be registered in the CTRI. In the CTRI, details of Indian investigators, trial sites, Indian target sample size and date of enrollment are captured. After a trial is registered, trialists are expected to regularly update the trial status or other aspects as the case may be. After a trial is registered, all updates and changes will be recorded and available for public display.
Siro Clinical Research Institute
Post Graduate Diploma in Clinical Research
www.siroinstitute.com
www.siroclinpharm.com
Introduction to Clinical Research RegulationsClinosolIndia
Clinical research plays a vital role in advancing medical knowledge, developing new treatments, and improving patient care. However, conducting clinical trials involves numerous ethical and regulatory considerations to ensure participant safety, data integrity, and compliance with applicable laws and guidelines.
The mission of the Clinical Trials Registry-India (CTRI) is to ensure that all clinical trials conducted in India are prospectively registered, i.e. before the enrolment of the first participant. Additionally, post-marketing surveillance studies, BA/BE studies as well as clinical studies as part of PG thesis are also expected to be registered in the CTRI. The vision of the CTRI is to ensure that every clinical trial conducted in the region is prospectively registered with full disclosure of the trial data set items. While this register is meant primarily 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, provided ethics approval (in English) is available and the study has not begun enrolling. The Clinical Trials Registry- India (CTRI), hosted at the ICMR's National Institute of Medical Statistics (http://icmr-nims.nic.in), is a free and online public record system for registration of clinical trials being conducted in India that was launched on 20th July 2007 (www.ctri.nic.in). Initiated as a voluntary measure, since 15th June 2009, trial registration in the CTRI has been made mandatory by the Drugs Controller General (India) (DCGI) (www.cdsco.nic.in). Moreover, Editors of Biomedical Journals of 11 major journals of India declared that only registered trials would be considered for publication1, 2.
Today, any researcher who plans to conduct a trial involving human participants, of any intervention such as drugs, 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 AYUSH (http://indianmedicine.nic.in/) is expected to register the trial in the CTRI before enrollment of the first participant. Trial registration involves public declaration and identification of trial investigators, sponsors, interventions, patient population etc before the enrollment of the first patient. Submission of Ethics approval and DCGI approval (if applicable) is essential for trial registration in the CTRI. Multi-country trials, where India is a participating country, which have been registered in an international registry, are also expected to be registered in the CTRI. In the CTRI, details of Indian investigators, trial sites, Indian target sample size and date of enrollment are captured. After a trial is registered, trialists are expected to regularly update the trial status or other aspects as the case may be. After a trial is registered, all updates and changes will be recorded and available for public display.
Siro Clinical Research Institute
Post Graduate Diploma in Clinical Research
www.siroinstitute.com
www.siroclinpharm.com
Introduction to Clinical Research RegulationsClinosolIndia
Clinical research plays a vital role in advancing medical knowledge, developing new treatments, and improving patient care. However, conducting clinical trials involves numerous ethical and regulatory considerations to ensure participant safety, data integrity, and compliance with applicable laws and guidelines.
Clinical Trial Registration
International Clinical Trials Registry Platform (ICTRP)
What is the Primary Register?
Clinical Trial Registry - India (CTRI)
Goal and Objectives of the Registry
How to Register?
“CSR is a detailed regulatory document which gives the information about the methods and results (related to efficacy and safety) of a clinical trial. CSRs are created as a part of the process of submitting applications to the Regulatory Authorities for new medical treatments and for its approval. CSRs can be full, abbreviated, synopsis, supplementary, observational etc as per the results and requirements”.
Regulatory medical writing is an integral part of Medical Communications, but is often overlooked. In simple terms, it involves writing of the documents required for the approval of drugs by the regulatory authorities.
https://www.cognibrain.com/regulatory-medical-writing/
Turacoz Healthcare Solutions provides clinical research and regulatory writing services for pharmaceutical companies. We tell you about the different components of a clinical study protocol, the document which is prepared before beginning of any clinical trial. To know more info, visit- goo.gl/C1ec0L or write to us at hello@turacoz.in and call us 011-40584280.
In any work or process documents that are needed before initiation, Between or generally the end of the process just like in a clinical trial those “Documents which permit evaluation of the conduct of a trial and the quality of the data produced. It is given in the 8th section of the ICH-GCP.
TMF Fundamentals - An Introduction to Better Trial Master File Management - M...Montrium
In this presentation, we explore the TMF fundamentals and an introduction to better managing your TMF. We'll start by diving into the world of TMF management, how to properly leverage the regulations, which documents constitute as TMF-worthy and what basic metrics you can track to increase the efficiency of your trial.
Finally, we will also discuss some of the features Montrium has developed to facilitate the management of the Trial Master File in a fundamental way.
This presentation covers the following topics:
-Fundamentals of TMF management process
-How to use the regulations to ensure success
-What cross functional groups hold TMF worthy documents
-TMF management challenges and how you can alleviate them
-Base metrics to track and what they mean to your organization
-How an eTMF helps TMF Management
You can follow along with this presentation via our webinar:
https://info.montrium.com/tmf-fundamentals-an-introduction-to-better-trial-master-file-management
Clinical study on human subjects according to all guidelines to form a ideal protocol and requirement to conduct clinical trial with very efficient way mainly considering to India and ICH associated countries
Clinical Trial Registration
International Clinical Trials Registry Platform (ICTRP)
What is the Primary Register?
Clinical Trial Registry - India (CTRI)
Goal and Objectives of the Registry
How to Register?
“CSR is a detailed regulatory document which gives the information about the methods and results (related to efficacy and safety) of a clinical trial. CSRs are created as a part of the process of submitting applications to the Regulatory Authorities for new medical treatments and for its approval. CSRs can be full, abbreviated, synopsis, supplementary, observational etc as per the results and requirements”.
Regulatory medical writing is an integral part of Medical Communications, but is often overlooked. In simple terms, it involves writing of the documents required for the approval of drugs by the regulatory authorities.
https://www.cognibrain.com/regulatory-medical-writing/
Turacoz Healthcare Solutions provides clinical research and regulatory writing services for pharmaceutical companies. We tell you about the different components of a clinical study protocol, the document which is prepared before beginning of any clinical trial. To know more info, visit- goo.gl/C1ec0L or write to us at hello@turacoz.in and call us 011-40584280.
In any work or process documents that are needed before initiation, Between or generally the end of the process just like in a clinical trial those “Documents which permit evaluation of the conduct of a trial and the quality of the data produced. It is given in the 8th section of the ICH-GCP.
TMF Fundamentals - An Introduction to Better Trial Master File Management - M...Montrium
In this presentation, we explore the TMF fundamentals and an introduction to better managing your TMF. We'll start by diving into the world of TMF management, how to properly leverage the regulations, which documents constitute as TMF-worthy and what basic metrics you can track to increase the efficiency of your trial.
Finally, we will also discuss some of the features Montrium has developed to facilitate the management of the Trial Master File in a fundamental way.
This presentation covers the following topics:
-Fundamentals of TMF management process
-How to use the regulations to ensure success
-What cross functional groups hold TMF worthy documents
-TMF management challenges and how you can alleviate them
-Base metrics to track and what they mean to your organization
-How an eTMF helps TMF Management
You can follow along with this presentation via our webinar:
https://info.montrium.com/tmf-fundamentals-an-introduction-to-better-trial-master-file-management
Clinical study on human subjects according to all guidelines to form a ideal protocol and requirement to conduct clinical trial with very efficient way mainly considering to India and ICH associated countries
Introduction to disclosures in clinical trials. This presentation provides brief information about types of disclosures, FDAAA (www.clinicaltrials.gov) and EU (EudraCT) portals for clinical trial protocols and result summary disclosures in public domain.
Keeping with its promises, Association of the British Pharmaceutical Industry has launched a clinical-trial disclosure toolkit to help its member businesses observe with transparency needs for information from or about clinical trials.
Keeping with its promises, Association of the British Pharmaceutical Industry has launched a clinical-trial disclosure toolkit to help its member businesses observe with transparency needs for information from or about clinical trials.
clinical protocol & investigator information.pptx by Nitin KaleNitinKale46
What is a clinical trial protocol?
Clinical research is conducted according to a plan (a protocol) or an action plan. The protocol demonstrates the guidelines for conducting the trial. It illustrates what will be made in the study by explaining each essential part of it and how it is carried out. An Investigator is selected by the sponsor to conduct a clinical trial. An Investigator should be qualified but they don’t necessarily need to be a physician, although a medical professional should be listed as a ‘sub-investigator if that is the case.
Digital Scholar Webinar: Clinicaltrials.gov Registration and Reporting DocumentsSC CTSI at USC and CHLA
This 60-minute webinar covers the basic requirements for registration and results reporting requirements in Clinicaltrials.gov. Tips and tricks will be provided, as well as the most common issues to avoid to ensure a smooth and efficient process for public posting and updates to clinical studies. Learning Objectives At the conclusion of this webinar, participants will be able to identify internal contacts and resources available to assist with their Clinicaltrials.gov registration or results reporting.
What is The Clinical Trial Approval Process In India.pdfPranshuCorpseed
Clinical trials are critical in the development of novel medications and cures, advancing medical science and patient care. The clinical trial ecosystem in India has grown dramatically, making it an appealing destination for pharmaceutical research. This article explores the regulatory framework, ethical concerns, phases of clinical trials, application processes, review, post-approval requirements, obstacles, case studies, and future prospects of clinical trial approval in India.
Good Clinical practices (GCP) Guidelines and Ethical Issues, CME cum Workshop...Dr Rahul Saini
Souvenir of GCP Guidelines and Ethical Issues, CME cum Workshop held on 6th April 2019 at BPS GMC for Womnen Khanpur Kalan,Sonipat,
Conducted by
Department of pharmacology
& Institutional Ethics Committee
BPS GMC for women ,Khanpur kalan,Sonipat
Commendable CME cum workshop was conducted on
"“GCP Guidelines and Ethical Issues in Clinical Research”
by Department of Pharmacology
BPS,GMC for women,Khanpur kalan,Sonipat
Eminent Speakers:Dr KK Sharma,Dr Samir Malhotra,Dr MC Gupta,Dr Sandeep kaushal ,Dr Savita verma enlightened the participants with their outstanding talk on topic.
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Ve...kevinkariuki227
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
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Tom Selleck Health: A Comprehensive Look at the Iconic Actor’s Wellness Journeygreendigital
Tom Selleck, an enduring figure in Hollywood. has captivated audiences for decades with his rugged charm, iconic moustache. and memorable roles in television and film. From his breakout role as Thomas Magnum in Magnum P.I. to his current portrayal of Frank Reagan in Blue Bloods. Selleck's career has spanned over 50 years. But beyond his professional achievements. fans have often been curious about Tom Selleck Health. especially as he has aged in the public eye.
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Introduction
Many have been interested in Tom Selleck health. not only because of his enduring presence on screen but also because of the challenges. and lifestyle choices he has faced and made over the years. This article delves into the various aspects of Tom Selleck health. exploring his fitness regimen, diet, mental health. and the challenges he has encountered as he ages. We'll look at how he maintains his well-being. the health issues he has faced, and his approach to ageing .
Early Life and Career
Childhood and Athletic Beginnings
Tom Selleck was born on January 29, 1945, in Detroit, Michigan, and grew up in Sherman Oaks, California. From an early age, he was involved in sports, particularly basketball. which played a significant role in his physical development. His athletic pursuits continued into college. where he attended the University of Southern California (USC) on a basketball scholarship. This early involvement in sports laid a strong foundation for his physical health and disciplined lifestyle.
Transition to Acting
Selleck's transition from an athlete to an actor came with its physical demands. His first significant role in "Magnum P.I." required him to perform various stunts and maintain a fit appearance. This role, which he played from 1980 to 1988. necessitated a rigorous fitness routine to meet the show's demands. setting the stage for his long-term commitment to health and wellness.
Fitness Regimen
Workout Routine
Tom Selleck health and fitness regimen has evolved. adapting to his changing roles and age. During his "Magnum, P.I." days. Selleck's workouts were intense and focused on building and maintaining muscle mass. His routine included weightlifting, cardiovascular exercises. and specific training for the stunts he performed on the show.
Selleck adjusted his fitness routine as he aged to suit his body's needs. Today, his workouts focus on maintaining flexibility, strength, and cardiovascular health. He incorporates low-impact exercises such as swimming, walking, and light weightlifting. This balanced approach helps him stay fit without putting undue strain on his joints and muscles.
Importance of Flexibility and Mobility
In recent years, Selleck has emphasized the importance of flexibility and mobility in his fitness regimen. Understanding the natural decline in muscle mass and joint flexibility with age. he includes stretching and yoga in his routine. These practices help prevent injuries, improve posture, and maintain mobilit
Title: Sense of Smell
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the primary categories of smells and the concept of odor blindness.
Explain the structure and location of the olfactory membrane and mucosa, including the types and roles of cells involved in olfaction.
Describe the pathway and mechanisms of olfactory signal transmission from the olfactory receptors to the brain.
Illustrate the biochemical cascade triggered by odorant binding to olfactory receptors, including the role of G-proteins and second messengers in generating an action potential.
Identify different types of olfactory disorders such as anosmia, hyposmia, hyperosmia, and dysosmia, including their potential causes.
Key Topics:
Olfactory Genes:
3% of the human genome accounts for olfactory genes.
400 genes for odorant receptors.
Olfactory Membrane:
Located in the superior part of the nasal cavity.
Medially: Folds downward along the superior septum.
Laterally: Folds over the superior turbinate and upper surface of the middle turbinate.
Total surface area: 5-10 square centimeters.
Olfactory Mucosa:
Olfactory Cells: Bipolar nerve cells derived from the CNS (100 million), with 4-25 olfactory cilia per cell.
Sustentacular Cells: Produce mucus and maintain ionic and molecular environment.
Basal Cells: Replace worn-out olfactory cells with an average lifespan of 1-2 months.
Bowman’s Gland: Secretes mucus.
Stimulation of Olfactory Cells:
Odorant dissolves in mucus and attaches to receptors on olfactory cilia.
Involves a cascade effect through G-proteins and second messengers, leading to depolarization and action potential generation in the olfactory nerve.
Quality of a Good Odorant:
Small (3-20 Carbon atoms), volatile, water-soluble, and lipid-soluble.
Facilitated by odorant-binding proteins in mucus.
Membrane Potential and Action Potential:
Resting membrane potential: -55mV.
Action potential frequency in the olfactory nerve increases with odorant strength.
Adaptation Towards the Sense of Smell:
Rapid adaptation within the first second, with further slow adaptation.
Psychological adaptation greater than receptor adaptation, involving feedback inhibition from the central nervous system.
Primary Sensations of Smell:
Camphoraceous, Musky, Floral, Pepperminty, Ethereal, Pungent, Putrid.
Odor Detection Threshold:
Examples: Hydrogen sulfide (0.0005 ppm), Methyl-mercaptan (0.002 ppm).
Some toxic substances are odorless at lethal concentrations.
Characteristics of Smell:
Odor blindness for single substances due to lack of appropriate receptor protein.
Behavioral and emotional influences of smell.
Transmission of Olfactory Signals:
From olfactory cells to glomeruli in the olfactory bulb, involving lateral inhibition.
Primitive, less old, and new olfactory systems with different path
Ozempic: Preoperative Management of Patients on GLP-1 Receptor Agonists Saeid Safari
Preoperative Management of Patients on GLP-1 Receptor Agonists like Ozempic and Semiglutide
ASA GUIDELINE
NYSORA Guideline
2 Case Reports of Gastric Ultrasound
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Prix Galien International 2024 Forum ProgramLevi Shapiro
June 20, 2024, Prix Galien International and Jerusalem Ethics Forum in ROME. Detailed agenda including panels:
- ADVANCES IN CARDIOLOGY: A NEW PARADIGM IS COMING
- WOMEN’S HEALTH: FERTILITY PRESERVATION
- WHAT’S NEW IN THE TREATMENT OF INFECTIOUS,
ONCOLOGICAL AND INFLAMMATORY SKIN DISEASES?
- ARTIFICIAL INTELLIGENCE AND ETHICS
- GENE THERAPY
- BEYOND BORDERS: GLOBAL INITIATIVES FOR DEMOCRATIZING LIFE SCIENCE TECHNOLOGIES AND PROMOTING ACCESS TO HEALTHCARE
- ETHICAL CHALLENGES IN LIFE SCIENCES
- Prix Galien International Awards Ceremony
Report Back from SGO 2024: What’s the Latest in Cervical Cancer?bkling
Are you curious about what’s new in cervical cancer research or unsure what the findings mean? Join Dr. Emily Ko, a gynecologic oncologist at Penn Medicine, to learn about the latest updates from the Society of Gynecologic Oncology (SGO) 2024 Annual Meeting on Women’s Cancer. Dr. Ko will discuss what the research presented at the conference means for you and answer your questions about the new developments.
ARTIFICIAL INTELLIGENCE IN HEALTHCARE.pdfAnujkumaranit
Artificial intelligence (AI) refers to the simulation of human intelligence processes by machines, especially computer systems. It encompasses tasks such as learning, reasoning, problem-solving, perception, and language understanding. AI technologies are revolutionizing various fields, from healthcare to finance, by enabling machines to perform tasks that typically require human intelligence.
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*
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.