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- Overview of Indian drug regulatory system
- Overview of drugs & cosmetics Act and Rules thereunder
- Overview of New Drug and Clinical Trials Rules Rules, 2019
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Current Regulatory Requirements For Conducting Clinical Trials In India For Investigational New Drugs/New Drug (Version 3.0)
Join the popular Regulatory Requirements for Conducting Clinical Trials online programme and learn about clinical trials and the development of new drugs.
Online
8 Weeks
Free
Quick facts
particular | details | ||
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Medium of instructions
English
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Mode of learning
Self study
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Mode of Delivery
Video and Text Based
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number of course credit
2
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Course overview
The Regulatory Requirements for Conducting Clinical Trials programme has been developed by the Clinical Development Services Agency (CDSA) in association with NPTEL and Central Drugs Standard Control Organisation (CDSCO). It is a prerequisite course if you are interested in conducting clinical trials and involving yourself in developing new drugs. The course will also discuss the latest guidelines and regulations in the New Drugs and Clinical Trials (NDCT) Rules, 2019.
Regulatory Requirements for Conducting Clinical Trials certification is an elective course with a duration of eight weeks. It is a multidisciplinary course that you can access on Swayam, the online learning platform. There are no prerequisites to join this online course. All the course material is available for free. You will also have the chance to study under a reputed group of educators from multiple organisations and institutions.
Regulatory Requirements for Conducting Clinical Trials has an option for certification as well. You need to submit all the assignments and sit for the offline end-of-term exam to obtain it.
The highlights
- No prerequisites
- AICTE approved FDP
- Eight weeks duration
- Multidisciplinary course
- Latest information on NDCT
- UG/PG online course
- Faculty from multiple reputed organisations
- Elective course
- E-certification available
- No enrolment fee
- Developed by CDSA in association with NPTEL and CDSCO
- Available on Swayam
Program offerings
- Latest information on ndct
- Faculty from multiple reputed organisations
- Aicte approved fdp
- E-certification
- Elective online course
- No enrollment fee
Course and certificate fees
Type of course
- Regulatory Requirements for Conducting Clinical Trials training has no enrolment fee. There is an option exam fee of Rs. 1,000.
Regulatory Requirements for Conducting Clinical Trials programme fee structure
Course Name | Fee |
Regulatory Requirements for Conducting Clinical Trials (Exam fee) | Rs. 1,000 |
certificate availability
certificate providing authority
certificate fees
Eligibility criteria
Certification Qualifying Details
To obtain the Regulatory Requirements for Conducting Clinical Trials certification, you need to fulfill the below-given criteria. Fulfillment of all three requirements is necessary for certification.
Appear for offline exam and obtain an average score >=30/75
Submit all the assignments and obtain an average score of >= 10/25
Obtain a final score of >= 40/100 ,wherein final score = Assignment score + Exam score.
What you will learn
Upon completion of the Regulatory Requirements for Conducting Clinical Trials programme, you will understand
- The latest rules of New Drugs and Clinical Trials (NDCT) 2019 for new drug manufacturing and import
- Essential document requirement for approval of new drugs, clinical trials
- The importance and purpose of guidelines related to clinical trials
Who it is for
Regulatory Requirements for Conducting Clinical Trials certification course would be best suited for individuals who are working towards developing new drugs and conducting clinical trials and research for the same. This includes regulatory affairs personnel, clinical trial members, investigators, human ethics committee members and researchers. Students who are studying various courses in pharmaceutical, medicine, biotech will also benefit from this course.
Admission details
Join the Regulatory Requirements for Conducting Clinical Trials programme by following these steps:
- Go to the Swayam website: Link: https://swayam.gov.in/.
- Click on ‘Sign-in/Register’ and enter appropriate credentials.
- Go to the course link: https://onlinecourses.nptel.ac.in/noc21_ge14/preview and find out if enrollment is open.
- If the course is open for enrollment, click on ‘Join’.
Filling the form
To apply for the Regulatory Requirements for Conducting Clinical Trials programme, you need to log in on the Swayam website. To do so, you can use an existing Swayam account or use your Google/Microsoft/Facebook account. If you don’t have any of these, you can sign up using your email address and choose a username and password. Once the email has been verified, your application is complete.
The syllabus
Week 1
Week 2
- Pre-clinical data requirements
- Rules governing clinical trials
- Phases of clinical trial, forms, and fees
- Regulatory pathway and data requirements for NDCT, 2019
Week 3
- BA/BE study and study centres: Legal provisions
- Guidelines to conduct BA/BE studies
- Ethics Committee registration and re-registration
Week 4
- Ethical considerations
- Good Clinical Practice
- Requirements for import/manufacture of new drug/IND for conducting clinical trials in India
- Requirements for import/manufacture of new drug/IND for sale/distribution and unapproved new drug for patients
Week 5
- Important issues
- Special concerns
- Clinical trial related guidelines (NDCT Rules)
Week 6
- Content of proposed clinical trial protocol
- Content of a clinical trial report
- Post marketing assessment and clinical trial compensation
Week 7
- Common observations during submission of CT/BA/BE protocol
- Common observations during CT/BA/BE centre inspections
- Drug development process: Overview
Week 8
- Salient feature of NDCT 2019 (What's new in NDCT?)
- Online submission (SUGAM)
- Online submission (CTRI)
- Tables given in NDCT 2019 and its content
Evaluation process
Regulatory Requirements for Conducting Clinical Trials training has an optional in-person proctored exam held at the end of the course. If you want a certificate, you can appear for this course by filling up an online registration form and paying the exam fee. There are multiple exam centres and two sessions to choose from. All exam-related details and information regarding exam centres will be given to you once you register for the exam.
How it helps
Regulatory Requirements for Conducting Clinical Trials by Swayam is a popular course that offers immense knowledge about clinical trials for new drug development. The certificate your receive in this course will be useful in pursuit of a career in the pharmaceutical industry, biotech industry, contract, new drug development and clinical trials.
Instructors
Dr D. K. Sable
Assistant Drugs Controller
Central Drugs Standa...
Dr Rubina Bose
Deputy Drugs Controller
Central Drugs Standa...
Mr Y. K. Gupta
Professor
CDSA
Dr Nandini K. Kumar
Adjunct Faculty
CDSA
Mr Arun Kumar B Ramteke
Former Joint Drugs Controller
Central Drugs Standa...
Dr Sucheta Banerjee Kurundkar
Director
CDSA
Dr M. Vishnu V. Rao
Instructor
Freelancer
Dr Atul Juneja
Coordinator
Freelancer
Dr Tulsi Adhikari
Coordinator
Freelancer
Dr Mohua Maulik
Consultant
Freelancer
FAQs
You can verify the Regulatory Requirements for Conducting Clinical Trials certificate at https://nptel.ac.in/noc/.
No. Regulatory Requirements for Conducting Clinical Trials exam is only for participants who want a certificate.
Regulatory Requirements for Conducting Clinical Trials programme is an elective course.
The study material can be accessed on the Swayam platform https://swayam.gov.in/.
No. Enrollment is currently closed for this programme. However, you can always visit the Swayam website to get the latest updates.