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Why this course and Industry Outlook

• Clinical Research is a Life Science domain that has grown significantly in post COVID environment and there is tremendous dearth of skilled resources.
• Any organisation intending to get into Clinical Research will need skilled resources as Clinical Research associate so that they can confidently create clinical research sites in their organisation.
• While Ethics Committee is the prerequisite, the organisation need to get opportunity to get trial sites and do clinical research.
• Going by increased health consciousness Pharma companies are coming with newer drugs, enhancing efficacy and new processes.
• As a result several healthcare establishments and CROs are getting into Clinical Research as a business opportunity. Consequently there are manifold in increase in CR sites.
• The course is designed by Clinical Resaerch Industry experts in collaboration with Life Science Sector Skill Development Council, MSDE, GOI and thus the studnetsb will be made ready for the industry that is set to grow and can grow with only trained manpower.

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Course Structure

Eligibility

B. Sc. (Biology, Nursing, Medical Lab technician, Life Sciences , Biotechnology, Pharmaceutical Science)/ B. Pharma / B. Tech (Bio Technology)/ Micro Biology M. Pharma/ M. Sc/ PhD in Pharmacology BDS/ BUMS/ BAMS/ BHMS. Medical Graduates will also qualify Additional Prerequisite Flair for research, process orientation, attention to details, documentation

Apprenticeship/ Internship

Students completing Semester I will be provided Apprenticeship opportunity in various Healthcare Establishments/ Pharma Companies, CROs, under National Apprenticeship Program of GOI or Internship at Healthcare Establishments or at CRO sites. Stipendiary support to students, who will be engaged in industry as an apprentice, will be as per prescribed stipend guidelines. Will be in any one of the Electives.

View Detailed Syllabus

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Course Coverage

• 1. Understand entire regulatory framework and compliance with Good Manufacturing Practices (GMP) and GCP(Good Clinical Practices) and other environmental regulatory guidelines.
• 2. Thorough understanding of good documentation practice (GDP) and data integrity while reporting and documentation as per standard operating procedures (SOP), good laboratory practices (GLP), and Good Manufacturing Practices (GMP)
• 3. Basic Principles of Clinical Pharmacology and Drug Action, Pharmacological concept in clinical research, protocol design, BA-BE studies
• 4. Develop and write trial protocols. Present trial protocols to a steering committee.
• 5. Design data collection forms, known as case report forms (CRFs).
• 6. Ethical Guidelines for Clinical Research, Coordination with the ethics committee, which safeguards the rights, safety and wellbeing of all trial subjects.
• 7. Managing regulatory authority applications and approvals that oversee the research and marketing of new and existing drugs.
• 8. Setting up the trial sites - ensuring each centre has the trial materials, including the trial drug often known as the investigational medicinal product (IMP)
• 9. Clinical trial site coordination, : Manage CRA activities at the site. Identify & assess the suitability of facilities to use as the clinical trial site. Identify/select an investigator who will be responsible for conducting the trial at the trial site.
• 10. Reporting and documentation for site coordination - Carry out reporting and documentation for site coordination activities as per regulatory standards
• 11. Safety and Hygiene at Clinical Trial Site and workplace
• 12. Clinical trial monitoring - Informed ConsentLiaise with doctors, consultants or investigators on conducting the trial.
• 13. Clinical trial monitoring - Clinical trial master file. Monitor the clinical trial site to ensure that ICH GCP guidelines, study protocol and applicable regulations are followed
• 14. Safety Definitions and Adverse Event Reporting Requirements
• 15. Verify that data entered on to the CRFs is consistent with patient clinical notes, known as source data/document verification (SDV). Collect completed CRFs from hospitals and general practices.
• 16. Reporting and documentation for site monitoring - Carry out reporting and documentation for site monitoring activities as per regulatory standards. Writing visit reports and file and collate trial documentation and reports.
• 17. Project Management in Clinical Trials. Closing down trial sites on completion of the trial and accounting for unused trial supplies
• 18. Clinical data management - Provide support for clinical data management activities
• 19. Coordinate with team members and site. Display of sensitivity towards all genders and people with disability
• 20. Soft skills

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Course Delivery

• 1. This course will be exclusively offered by Neotia Skill Development Academy with tripartite collaboration - NSDA, Industry Collaborator and LSSSDC.
• 2. To be delivered by Doctors and experts in the field of Clinical research engaged in Healthcare, CRO, Pharma Companies and Clinical Data Management
• 3. Practicals supported by Healthcare establishment / CRO and also in demo and mock environment
• 4. Field work, several assignments, live protocol design, opportunity to witness ethic committee proceedings
• 5. Opportunity to get engaged with CR trial sites during the course duration
• 6. Assignment based learning for the entire value chain ofma CRA with hands on demo, exercise, mock sessions
• 7. Extensive content kin the LMS platform

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Role Description

Clinical Research Associate (CRA) is involved in all stages of the clinical trial, including supporting the identification of an investigational site and setting up, initiating, monitoring and closing down the trial. The person will be responsible for supporting clinical trial activities, carrying out reporting and documentation of research activities and data management.

As a part of supporting clinical trial activities, the CRA carries out reporting and documentation for monitoring of research activities so as to ensure regulatory compliance and good clinical practices. Tasks vary depending on the employer and level of experience. However, CRAs typically need to:

• Develop and write trial protocols (outlining purpose and methodology)
• Present trial protocols to a steering committee
• Design data collection forms, known as case report forms (CRFs)
• Coordinate with the ethics committee, which safeguards the rights, safety and wellbeing of all trial subjects
• Manage regulatory authority applications and approvals that oversee the research and marketing of new and existing drugs
• Identify & assess the suitability of facilities to use as the clinical trial site
• Identify/select an investigator who will be responsible for conducting the trial at the trial site
• Liaise with doctors, consultants or investigators on conducting the trial
• Set up the trial sites - ensuring each centre has the trial materials, including the trial drug often known as the investigational medicinal product (IMP)
• Train the site staff to trial-specific industry standards
• Monitor the trial throughout its duration, which involves visiting the trial sites on a regular basis
• Verify that data entered on to the CRFs is consistent with patient clinical notes, known as source data/document verification (SDV)
• Collect completed CRFs from hospitals and general practices
• Wite visit reports and file and collate trial documentation and reports
• Ensure all unused trial supplies are accounted for
• Close down trial sites on completion of the trial
• Discuss results with a medical statistician, who writes technical trial reports
• Archive study documentation and correspondence
• Prepare final reports and occasionally manuscripts for publication
• Provide data management support

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Organisation which supported with OJT

 

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Sample projects that the students worked on

 

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Classroom Engagement

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Program Uniqueness

• Program is supported by Life Science Sector Skill Development Council (LSSSDC), NSDC, Ministry of Skill Development and Entrepreneurship, GOI.
• Students will get opportunities to get employed through the unique industry linked apprenticeship/ internship program, which is built into the programs.
• The program will be delivered by experts in the field and those who are engaged in various stages of Clinical Research.
• The program will facilitate Healthcare units at the proposed location to start the process of clinical research in accelerated manner.

Trainer Profile

Doctors, healthcare & pharma industry professionals, CROs, Clinical research veterans.

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