Professional Certification in Good Clinical Practice (GCP)

The ICH-GCP guidelines are developed to facilitate an international ethical and scientific quality standard for planning, executing, supervising, documenting, auditing, examining and reporting bio-medical and behavioral research studies concerning human population. The ICH-GCP guidelines provide platform to the industry in form of two basic standards: protecting the rights, safety and welfare of human subjects; and the genuineness of the data generated by the research. ICH-GCP guidelines confer objective to provide one single standard to facilitate the conduct of clinical trials across the US, European Union & Japan.

ICH-GCP training and certification is strongly recommended throughout the world as the guidelines are globally accepted. It is a basic acceptable standard for working as a clinical research professional. Getting Good Clinical Practice certified has multiple advantages such as:

• Various pharmaceutical/ biotech and clinical research organizations recommend GCP certification to their employees
• Organizations are hiring professionals certified in GCP for planning and conducting GCP audits (vendor, internal process and investigator site) and may include responsibilities for providing Quality Assurance support to clinical operations.
• Good clinical Practice (GCP) training is important for organizations in the business of clinical research so that they can comply with the industry guidelines, and regulations. 

Learning Outcomes

• To impart foundational and advanced knowledge on GCP principles.
• To develop competence in conducting ethical and compliant clinical trials.
• To align participants with current regulatory standards (CDSCO, US FDA, EMA, MHRA).
• To prepare professionals for audits and inspections. 

Key Highlights:

• Live Interactive Sessions by industry experts
• Case Study-Based Learning & practical scenarios
• Digital GCP Toolkit (templates, protocol, consent forms, case report form)
• Participation Certificate
• Networking Opportunities with industry professionals 

Target Audience:

• Clinical Research Associates (CRA) & Coordinators
• Pharmacovigilance and Regulatory Affairs Professionals
• Physicians and Site Investigators
• Medical, Pharmacy, Life Science Students & Graduates
• Quality Assurance & Compliance Officers 

Certified Study Resources

International Affiliation with

Module 1: Basic Introduction to Principles of ICH GCP, Overview of New Revision

Module 2: Difference between Indian GCP and ICH GCP, Consequences of GCP non-compliance

Module 3: Responsibilities of Sponsor, Investigator, Ethics Committee

Module 4: Essential Documents: Informed Consent, Protocol, Investigator’s Brochure

Module 5: SAE Reporting Process and Timelines

Module 6: Audit & Inspection in Clinical Research

Module 7: Investigational Product – Accountability

Module 8: Case Studies Discussion- Integrating GCP principles in Clinical Research Conduct 

Eligibility

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

Programme Duration

The duration of the training is 5 days.

Programme Mode

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

Programme Deliverables

The accompanying training is appropriately aligned with the current industry’s expectations.

• Interactive online live sessions on all key areas of the programme, offering flexibility to participants.
• Simplified, practical learning facilitated by experienced IGMPI faculty members.
• Module-wise assessments and evaluations designed to enhance competency and skill levels.
• Feedback sessions after every module for continuous improvement.
• All training and learning materials will be delivered in English. 

Assessment & Certification

All the participants are expected to appear for online assessment. After successfully qualifying the examination, the participants will be awarded Professional Certification in Good Clinical Practice (GCP) by IGMPI.

Placement Assistance & Corporate Relations

The Institute has partnered with numerous organizations to provide placement assistance to its participants. The robust placement cell comprises senior-level Human Resources professionals and Talent Acquisition experts who maintain close links with business and industry.

We promote the employability of our participants by maintaining strong relationships with HR departments and recruitment teams of leading clinical research, pharmaceutical, and CRO organizations. The placement cell also assists participants with professional resume writing, interview skills, and mock interview sessions.

Our alumni and professional participants have secured positions in organizations such as IQVIA, PPD, ICON plc, Parexel, Syneos Health, Covance, Sun Pharma, Dr. Reddy’s Laboratories, Biocon, Cipla, Glenmark, and other leading global CROs and pharmaceutical firms.

The IGMPI Corporate Resource Division actively recommends trained participants for suitable job openings and specialized quality roles within the clinical research and healthcare industries and is actively involved in taking various initiatives towards knowledge dissemination and training for life sciences students and professionals. 

Future Prospects

The future prospects for professionals certified in Good Clinical Practiceare exceptionally strong. With increasing global emphasis on regulatory compliance in clinical research and inspection preparedness, organizations are seeking certified professionals in GCP.

Certified GCP professionals can pursue roles such as:

• Clinical Research Associate (CRA
• Clinical Research Coordinator (CRC)
• Clinical Trial Assistant (CTA)
• Clinical Data Manager
• GCP Compliance Officer
• Regulatory Affairs Associate/ Officer
• Quality Assurance (QA) Executive / Auditor
• Clinical Project Assistant / Project Manager
• Site Management Associate (SMA) 

This certification opens doors to leadership roles in audit management, compliance consultancy, and quality system oversight across global CROs, sponsors, and regulatory environments and is ideal for professionals who wish to attain effective good clinical practice skills in compliance with applicable regulatory guidelines. The study programme is designed according to latest guidelines and updates and addressing all major requirements set aside by industry experts.

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Apply Online

Last date for submitting completed Application Form: 11:59 PM 1^st Dec 2025.

For further enquiries, call or write to us on:
18001031071 (Toll Free -9:00 am to 5:30 pm IST-except on Central Government holidays)/ info@igmpi.ac.in