Faculty of Clinical Research and Drug Safety (FCRDS) has been set up under the aegis of ‘Institute of Good Manufacturing Practices India' - an autonomous Institute recognised by Ministry of Commerce & Industry, accredited Vocational Institution of Ministry of Education, Government of India and approved by Food Safety and Standards Authority of India (FSSAI), presents a unique, friendly and interactive platform to get rid of all your GMP compliance related issues. GMP- an essential element of industries like pharmaceutical, cosmetic, Ayurveda, biotech, homeopathic, medical device and food manufacturing and sustainability services - in itself is the most dynamic part which witnesses frequent changes in terms of new rules being added and old ones being renewed. Thus, keeping oneself updated with current GMPs is essential to remain aligned with evolving industry requirement and standards.

Our team comprises knowledgeable professionals from diverse sectors such as Pharma, Healthcare, Food, Nutraceutical, Nutrition industries, pooling together their expertise, know-how, and practical experiences to create this GMP guide. IGMPI is moving hand in hand with technology advances and has gained recognition as a stronger and better education and training platform provider for professionals and students in the areas of GMP, Quality Assurance and Control, Pharma, Food & Nutrition, Environment and Healthcare Regulatory Affairs, Clinical Research, Pharmaceutical IPR and Good Laboratory Practice and Product Management. Our board of governors and specialists have collated their acumen and are offering state-of-the-art courses which includes GMP training, Quality Assurance and Control, Pharma and healthcare Regulatory Affairs, Clinical Research, Pharmaceutical IPR, Environment Social Governance (ESG), and Good Laboratory Practice in form of formal classroom studies, online/interactive programmes, online seminars, as well as onsite training programmes along with the knowledge of worldwide affairs of the industry. In short, a round-the-clock service is provided for any information in these areas required by anybody from around the country and abroad. Based on high standards of quality, the training programmes in Pharma, Healthcare and Food GMP, Quality Assurance and Quality Control, Regulatory Affairs, IPR, Pharma Product Management, Public Health, Hospital Management, Clinical Research, Pharmacovigilance, Medical Writing, Medical Coding, Nanotechnology, Drug Design and Discovery, Food QA&QC, etc., areas have been approved by Quality Council of India, which is an autonomous body and an accreditation authority for education & vocational training providers under the Ministry of Commerce & Industry, Government of India. IGMPI is duly licensed and certified by Bureau of Indian Standards (BIS) under Bureau of Indian Standards (Conformity Assessment) Regulations 2018.

IGMPI is an accredited Vocational Institution of the Ministry of Education, Government of India Institute of Good Manufacturing Practices India is Management System (QMS) certified under NABCB accreditation. IGMPI is also approved by Food and Life Sciences Sector Skill Councils recognized by the National Council of Vocational Education and Training (NCVET).

The Post Graduate and Executive Diploma programmes of IGMPI in Good Manufacturing Practices, Regulatory Affairs, Intellectual Property Rights, Quality Assurance and Quality Control, Public Health, Nanotechnology, Hospital Management, Product Management, Sales and Marketing Management, Clinical Research, Medical Writing, Drug Discovery and Development, Pharmacovigilance, Medical Coding have been duly assessed and approved by Quality Council of India, Government of India based on fulfillment of QCI's following criteria:

    1. Course Content
    2. Course Design
    3. Course Material
    4. Instructors
    5. Class size & Attendance
    6. Facilities
    7. Evaluation of Students
    8. Written Examination
    9. Certificate

IGMPI is also approved by Food Safety and Standards Authority of India (FSSAI) (FSSAI ID: TPINS18). IGMPI® is licensed by Department of Food Safety & Drug Administration under the Drugs and Cosmetics Act, 1940 and registered under Food Safety and Standards Act 2006.

IGMPI is also approved by Sector Skills Council under National Skill Development Corporation (NSDC) setup by Ministry of Skill Development & Entrepreneurship, Govt of India.

IGMPI has been conferred with the prestigious "BUREAU OF INDIAN STANDARDS (BIS) AWARD OF HONOUR 2023". QUALITY COUNCIL OF INDIA (QCI) has also conferred IGMPI with D.L. SHAH NATIONAL QUALITY AWARD, Certificate of Merit & ASSOCHAM has conferred IGMPI with the Services Excellence Award based on excellence of its services to the students and training participants.

Bureau of Indian Standards (BIS) is a member of International Organization for Standardization (ISO) and through the Indian National Committee (INC) which is a member of International Electrotechnical Commission (IEC). BIS is also a member of regional standards bodies like Pacific Area Standards Congress (PASC) and South Asian Regional Standards Organization (SARSO). India started taking part in IEC from 1911 and subsequently the then Indian Standards Institution (now BIS) took over the responsibility of Indian National Committee of IEC(INC-IEC) in 1949. Since then the INC-IEC is actively participating in the activities of the IEC both at the policy level and technical work and carrying out the responsibilities as member body of IEC Council. India is a member in Standards Management Board (SMB) of IEC since 2015.BIS has also signed Bilateral Cooperation Agreements (BCA)/Mutual Recognition Agreements (MRA) with the National Standards Bodies of several countries like Afghanistan, Bangladesh, Belarus, Egypt, European Union , Germany, Ghana, Greece, Indonesia, Iran, Japan, Jordon, Kenya, Kyrgyzstan, Mali, Mauritius, Nigeria, Russia, Saudi Arabia , Slovakia, Slovenia, Suriname, USA, UAE, Uzbekistan, Viet Nam, Bhutan, Brazil, Israel, Nepal, Pakistan and Sri Lanka.

National Accreditation Board for Certification Bodies (NABCB), Quality Council of India is a member of International Accreditation Forum (IAF) & Pacific Accreditation Cooperation (PAC) as well as signatory to its MLAs for Quality Management Systems, Environmental Management Systems and Product Certification. NABCB is also a Full Member of International Laboratory Accreditation Cooperation (ILAC) & Asia Pacific Laboratory Accreditation Cooperation (APLAC) as well as signatory to its MRAs for Inspection.

This professional certification is designed for both freshers entering the clinical research field and professionals working in clinical research, regulatory affairs, project management, quality assurance, and related fields who are involved in the preparation, maintenance, and management of the Trial Master File (TMF). The TMF is an essential component in clinical trials, ensuring compliance with regulatory requirements and providing evidence of trial conduct and data integrity.

The programme offers comprehensive training on how to set up, organize, manage, and audit the TMF in accordance with global regulatory standards such as ICH-GCP, FDA, EMA, and other health authorities.

Key Learning Outcomes

Upon completion of this programme, participants will be able to:

• Understand the purpose, structure, and content of the Trial Master File.
• Implement best practices for document collection, management, version control, and archiving
•  Maintain regulatory compliance through proper TMF governance.
• Navigate TMF requirements across different regions and regulatory bodies.
• Use electronic Trial Master File (eTMF) systems effectively.
• Conduct audits, inspections, and corrective actions for TMF gaps.
• Support clinical trial operations, risk management, and data integrity.

Programme Structure

Module 1: Clinical Trials and Regulatory Framework

• Overview of clinical trial phases and documentation.
• Regulatory requirements: ICH-GCP, FDA, EMA, MHRA.
• Introduction to TMF and its role in regulatory inspections.

Module 2: Introduction to TMF and Its Essential Components

• Definition and purpose of TMF.
• TMF structure, classification of documents, and lifecycle.
• Investigator Site Files (ISF) vs TMF – roles and responsibilities.
• Essential documents overview

Module 3: Regulatory Guidelines

• EMA, FDA, MHRA and CDSCO perspectives on TMF
• ALCOA+ principles of documentation
• DIA TMF Reference Model overview
• Common regulatory findings related to TMF

Module 4: TMF Structure & Documents

• Categories & sections in TMF
• Start-up, conduct, and close-out documents
• Document version control & lifecycle
• Mapping documents into TMF Reference Model

Module 5: Paper TMF vs eTMF

• Advantages & limitations
• Overview of eTMF systems (Veeva Vault)
• Metadata, indexing, and audit trails
• eTMF navigation

Module 6: TMF Management & Operations

• Set-up, maintenance, archival of TMF
• Filing conventions & naming standards
• QC & completeness checks
• TMF metrics and dashboards

Module 7: Quality, Compliance & Inspections

• TMF Health Check methodology
• CAPA management for TMF findings
• Preparing TMF for regulatory inspection
• Inspection & audit readiness

Module 8: Roles & Responsibilities

• CTA, CRA, Trial Manager, Document Specialist roles
• Sponsor vs CRO responsibilities
• Communication & escalation in TMF management

Module 9: Practical Sessions / Case Studies

• Example TMF set-up exercise
• Reviewing sample documents
• Simulated TMF inspection

Module 10: Project/Assignment:

• Assignment: Organize sample TMF documents into correct sections

Eligibility

Graduates in any discipline are eligible for our Post Graduate Diploma, Executive Diploma and Professional Certification Programmes.

Programme Duration

The minimum duration to complete the Professional Certification programme is 6 months and maximum is 12 months.

Programme Mode

Registration is currently open for Part-time (Online Live Classes) mode.

Programme Deliverables

A comprehensive study material for all the modules in hard copies ensuring the needs of the audience. The accompanying training material is appropriately aligned with the current Industry’s expectations.

• Assignments for all the programme modules for continuous evaluation and guidance.
• Interactive or online live sessions on all key areas of the programme giving all flexibility to the participants.
• Online Live Classes/Part-time for all the modules will be conducted on the weekends. Moreover, a doubt clearing session will also be scheduled before the examination.
• All the efforts are made by IGMPI faculty members to make the entire programme modules easily understandable.
• Assessment and evaluation for all the programme modules in order to enhance the levels of competencies and skills of the participants leading towards the objective of application in the job.
• At the end of each programme modules, the trainers shall obtain feedback from the participants using specially designed questionnaires.
• All learning and training delivery initiatives shall be conducted in English.

Assessment & Certification

IGMPI follows a credit system based on all learning activities involved in studying for all PG Diploma, Executive Diploma and Professional Certification. Each of your modules is equal to 4 credits. To successfully complete the programme, you will have to earn all the credits assigned to your programme.

All the participants are expected to appear for online exam and are also obliged to submit assignments. After successful completion the participants will be awarded Professional Certification in Trial Master File (TMF) Management by IGMPI. For all the above mentioned modules elaborate programme material, assignment and case studies would be provided by the Institute from time to time. Details get updated on the webpage as well.

Placement Assistance & Corporate Relations

The Institute has partnered with many organizations for providing with placement assistance to its participants. Besides, it has a robust placement cell comprised of senior level Human Resources professionals and Talent Acquisition experts which maintains close links with business and industry. This cell is continuously engaged in promoting the employability of our participants and encouraging the concerned Human Resources department and Hiring Managers to recruit/hire our participants for their vacant positions. The efforts of our placement cell also include helping with professional resume writing & interview skills.

In recent months the Institute has witnessed more and more participation from professionals working with global pharmaceutical like IQVIA, Parexel, Syneos Health, Fisher Clinical Services, Dr. Reddy’s Laboratories, Divi’s Laboratories, GVK Biosciences, Avra Labs, SRL Ranbaxy, Torrent Pharmaceutical Ltd., Novartis Life Sciences, Jubilant Lifesciences Ltd., Aurobindo Pharmaceuticals Ltd., Venus Remedies Ltd., etc. The IGMPI’s Corporate Resource Division actively recommends our students and training participants for various job requirements and specialized roles to Human Resource, Talent Acquisition as well as the heads of various departments in Pharmaceutical, Healthcare industries on regular basis.

Future career prospects of Training in Professional Certification in Trial Master File (TMF) Management

This certification prepares candidates for a wide range of career opportunities in clinical research by developing expertise in TMF management, documentation, and regulatory compliance. It benefits both newcomers seeking structured guidance and professionals aiming to enhance their expertise or move laterally within the industry. The program covers trial methodologies, documentation standards, quality control, regulatory compliance, and other critical aspects, enabling participants to pursue career opportunities in Trial Master File (TMF) Management and related areas within pharmaceutical and healthcare organizations. The certification supports career growth by providing up-to-date, practical training aligned with industry requirements.