Certified Principal Investigator Program (CPIP)
Beginner | Aspirant
Demonstrate your understanding of clinical research with this industry-relevant certification and unlock opportunities across the healthcare and pharmaceutical sectors. The Fundamental Insights of Clinical Research (FICR) certification recognizes individuals equipped with foundational knowledge of clinical trials, drug development, regulatory basics, and key functional areas within the clinical research domain.
Become a Future-Ready Principal Investigator in Clinical Research
- PI & Co-I focused, doctor-centric curriculum
- Training by experienced industry experts
- Participate in global research programs
- Real-world, case-based learning approach
Get Certified - CPIP
The Certified Principal Investigator Program (CPIP) is a specialized short-term program designed to equip medical professionals with in-depth knowledge and practical competencies required to lead clinical trials as Principal Investigators and Co-Investigators. This program bridges the gap between clinical practice and research leadership, enabling doctors to effectively manage clinical trials in compliance with regulatory, ethical, and operational standards across clinical trial sites, healthcare institutions, CROs, pharmaceutical, biopharmaceutical, and medical device organizations.
🗓 Upcoming Batches
- January 21, 2026
- April 1, 2026
- July 1, 2026
- October 1, 2026
⏱ Duration
- 1 Month | 15 Sessions | 30, Hours
💰 Programme Fee
- ₹35,000/- + Applicable Taxes (Approx. $420 USD + Taxes)
🎓 Eligibility Criteria
- MBBS / BDS / BHMS / BAMS / MD / MS or equivalent medical qualification
- Registered medical practitioners preferred
- Interest in clinical research and clinical trials
Limited Seats per Batch – Enroll Now for the Upcoming Quarterly Intake
Become eligible to act as a Principal Investigator / Co-Investigator
Expand practice into research-driven healthcare models
Contribute to drug development and evidence-based medicine
Access advanced treatment protocols
Program Overview
The Certified Principal Investigator Program (CPIP) offered by IILS is a comprehensive, short-term certification program thoughtfully designed for medical professionals aspiring to lead and manage clinical trials as Principal Investigators (PI) and Co-Investigators (Co-I). It is designed to equip doctors with a strong clinical and research-oriented foundation while aligning with current industry and regulatory requirements across clinical trial sites, healthcare institutions, CROs, pharmaceutical, biopharmaceutical, and medical device organizations.
Across structured sessions, the program covers a full spectrum of clinical research knowledge-from core fundamentals to investigator-level responsibilities. The journey begins with an introduction to clinical research, trial phases, and ethical guidelines, gradually advancing into protocol understanding, regulatory compliance, site feasibility, patient recruitment, and trial execution. As the program progresses, participants gain focused exposure to informed consent processes, safety reporting, documentation practices, and coordination with sponsors and regulatory authorities-essential for real-world clinical trial conduct.
The curriculum integrates theoretical understanding with practical insights, case-based discussions, and industry-relevant scenarios to ensure participants are professionally prepared. By the end of the program, doctors are equipped not only with subject knowledge but also with leadership, decision-making, and operational skills required to effectively manage and oversee clinical trials in real-world settings.
At the end of the program, participants must undergo an assessment based on key learning outcomes and practical understanding. A minimum qualifying score is required to successfully earn the certification. This evaluation process ensures professional competence, accountability, and readiness to take on Principal Investigator responsibilities in clinical research.
Principal Investigator (PI)
A person responsible for the conduct of the clinical trial, including the trial participants for whom that person has responsibility during the conduct of the trial. If a trial is conducted by a team of individuals, the investigator is the responsible leader of the team and may be called the principal investigator. Where an investigator/institution is referenced in this guideline, it describes expectations that may be applicable to the investigator and/or the institution in some regions. Where required by the applicable regulatory requirements, the “investigator” should be read as “investigator and/or the institution.”
Responsibilities:
- Direct interaction with research subjects to ensure informed consent.
- Monitor safety and well-being of participants.
- Ensure adherence to study protocol and regulations.
- Address any patient concerns related to the trial.
Sub-Investigator (Sub-I)
Responsibilities:
- Assists the PI in conducting the clinical trial.
- Interacts with patients during visits to ensure protocol compliance.
- Provides clinical care and supervises patient safety.
- Acts as a secondary point of contact for subjects, supporting the PI.
Course Curriculum:
Module 1: Clinical Research Foundations (5 Sessions)
- Session 1: Introduction to Clinical Research & Trial Phases
- Session 2; Roles & Responsibilities of PI & Co-I
- Session 3: ICH-GCP Guidelines
- Session 4: Clinical Trial Protocol
- Session 5: Investigator’s Brochure (IB)
Module 2: Trial Operations & Site Management (5 Sessions)
- Session 6: Informed Consent Process (ICF)
- Session 7: Site Feasibility & Selection
- Session 8: Patient Recruitment & Retention
- Session 9: Source Documentation & Data Integrity
- Session 10: Clinical Trial Agreements & Budgeting
Module 3: Compliance, Safety & Leadership (5 Sessions)
- Session 11: Safety Reporting & Pharmacovigilance
- Session 12: Monitoring, Audits & Inspections
- Session 13: Risk Management in Clinical Trials
- Session 14: Investigator-Initiated Studies (IIS)
- Session 15: Real-World Case Studies
Assessment
Assessment
- Final evaluation at the end of the program
- Minimum 60% score required for certification
Learning Mode:
Delivered entirely online through IILS’s Learning Management System (LMS), ensuring flexible and accessible learning.
Distance (Online)
Program Highlights
Designed for students and aspiring professionals in clinical research
Focus on foundational concepts and entry-level career readiness
Covers ICH-GCP, CDSCO, FDA, and global regulatory basics
Practical insights into clinical trial processes and industry workflows
Case-based learning and real-world clinical scenarios
Certificate aligned with industry and regulatory expectations
World-class learning delivered through live, faculty-led sessions
Renowned Faculty
Learn from experienced clinical research professionals with extensive industry and trial management expertise
Live interactive sessions led by subject matter experts in clinical trials and regulatory practices
Gain practical insights from real-world clinical trial scenarios and case-based discussions
Cohort-Based Learning
Learn alongside a curated group of medical professionals and clinicians
Engage in peer discussions, case evaluations, and collaborative learning
Build a strong professional network within the clinical research ecosystem
Flexible Learning
Attend live sessions through IILS’s Learning Management System (LMS)
Access recorded sessions and learning materials anytime, anywhere
Designed to fit alongside busy clinical and professional schedules
Who Should Enroll?
Practicing doctors interested in becoming Principal Investigators (PI)
Faculty members in medical colleges
Consultants and clinicians working in hospitals or private practice
Doctors looking to collaborate with pharmaceutical and biotechnology companies
Medical professionals aiming to participate in clinical trials and research projects
Investigators interested in conducting Investigator-Initiated Studies (IIS)
Doctors associated with or planning to develop clinical trial sites
Doctors seeking to expand into clinical research, CROs, or pharma collaborations
Industries Involved
Pharmaceutical:
- e.g., Drug development
Biotechnology
- e.g., Medical product innovation
Medical Device Companies
- e.g., Development and testing of devices like implants, diagnostic tools
Hospital
- Conducting Clinical trials at the site
Programme Faculty
Dr. Garima Dixit
Doctorate in Business Administration (Swiss School of Business, Geneva) | PGDCR | M.Sc in Biotechnology (University of Mumbai) Project Management Expert | Clinical Research Consultant | Faculty – Clinical Operations
Samiksha Kashyap
M.Sc. Clinical Research (Cranfield University, UK) | PGD in Training & Development (TISS) Project Management Expert | Clinical Research Consultant | Faculty – Clinical Operations & BD
Sanjeet Kumar
MBA In BM (NMIMS) | PGDACR and PV (ICRI) | B.Sc. BIOTECH (NC) Entrepreneur | Healthcare Trailblazer | Leadership Advancer Founder & CEO – IQVAMED | Program Director & Chairman at IILS
Shivani Khare
MBA in Business Management (NMIMS) | PGDCR (Clinomic) | B.Sc. Biotech (Nagpur University) Clinical Research Specialist | Part Time Educator | Corporate Professional
Dr. Anjali Sable
MBBS (Shivaji University) | Founder & CEO – Milagro Clinical Research Global Clinical Research Leader | Project Management Strategist | Mentor
Programme Certificate
Participants who successfully achieve a minimum score of 60% in the overall evaluation will be awarded a Certificate of Successful Completion from IILS, recognizing their competence in clinical research and investigator responsibilities.
Participants who do not meet the minimum qualifying criteria will not be eligible for certification.
Participants who successfully complete the program will be equipped with industry-relevant knowledge and practical competencies to confidently contribute as Clinical Research professional or leadership in Drug Development Domain.
Learning Outcomes
Understand the complete lifecycle of a clinical trial
Manage clinical trial documentation and site operations
Perform responsibilities of a Principal Investigator effectively
Collaborate with sponsors, CROs, and regulatory authorities
Ensure compliance with GCP and regulatory requirements
Initiate and lead investigator-driven clinical studies
Conduct ethical and patient-centric clinical research
Expand practice into research-driven healthcare models
Real-World Clinical Trial Case Studies
⚠️ Case1: Informed Consent Failure
Issue: Patients enrolled without proper consent PI Gap: Lack of ethical understanding Learning: Importance of ICF & patient rights
⚠️ Case 2: SAE Reporting Delay
Issue: Delay in reporting serious adverse events PI Gap: Poor safety monitoring Learning: Real-time pharmacovigilance
⚠️ Case 3: Protocol Deviation
Issue: Missed visits / incorrect dosing PI Gap: Weak site oversight Learning: Protocol adherence
⚠️ Case 4: Data Integrity & Fabrication
Issue: Clinical data manipulated or inaccurately recorded PI Gap: Lack of data oversight and verification Learning: Importance of accurate, complete, and verifiable data
⚠️ Case 5: Poor Patient Recruitment
Issue: Trial delays due to low or slow patient enrollment PI Gap: Inadequate feasibility and recruitment planning Learning: Effective recruitment strategies and site feasibility
⚠️ Case 6: Lack of Investigator’s Brochure (IB) Understanding
Issue: Safety risks overlooked due to poor IB review PI Gap: Limited understanding of drug profile and risks Learning: Thorough IB review and risk-benefit assessment
⚠️ Case 7: Monitoring & Audit Findings
Issue: Major observations during monitoring or regulatory audits PI Gap: Poor documentation and compliance readiness Learning: Maintain audit-ready documentation and site preparedness
⚠️ Case 8: Conflict of Interest in Clinical Trials
Issue: Financial or personal interests influencing trial conduct PI Gap: Lack of transparency and ethical judgment Learning: Disclosure and management of conflicts of interest
⚠️ Case 9: Safety Oversight Failure
Issue: Delayed identification of safety concerns in participants PI Gap: Weak safety monitoring and response system Learning: Continuous safety assessment and timely intervention
Snehal Bodke| Bachelor of Pharmacy
MET's Institute of D Pharmacy, Nashik, MH
The Fundamentals of Clinical Research (FICR) course provided a strong foundation in the principles and practices of clinical research. The sessions were well-structured and covered key topics such as study design, ethics, data management, and regulatory guidelines. The instructors explained complex concepts clearly and encouraged active participation, making the learning experience engaging and effective. The course materials were comprehensive, well-organized, and easy to follow. I especially appreciated the practical examples and case studies, which helped connect theoretical knowledge with real-world applications. The sessions conducted by experienced professionals provided valuable industry insights, helping us understand how CROs and the clinical research field operate. Overall, the course not only enhanced knowledge but also boosted confidence to pursue a career in clinical research.
FAQs
1. Who is this program designed for?
This program is designed exclusively for medical professionals (MBBS, BDS, BHMS, BAMS, MD/MS) who aspire to become Principal Investigators (PI) or Co-Investigators (Co-I) in clinical trials.
2. Do I need prior experience in clinical research to enroll?
No prior experience is required. The program starts with foundational concepts and progressively builds toward advanced investigator-level responsibilities.
3. What will I gain from this program?
Participants will gain practical knowledge of clinical trial conduct, regulatory compliance, GCP guidelines, patient safety, and the responsibilities of a Principal Investigator.
4. Will this program help me become a Principal Investigator (PI)?
Yes, the program is specifically designed to prepare doctors for PI/Co-I roles by providing the required knowledge, practical insights, and regulatory understanding.
5. What is the mode of learning?
The program is delivered entirely online through IILS’s Learning Management System (LMS), ensuring flexibility and accessibility.
6. What is the duration of the program?
The program is a short-term certification consisting of 15 sessions, delivered over approximately 1 month (30 hours).
7. Is there any assessment or certification?
Yes, participants must complete an assessment at the end of the program. Upon successful completion, a certification from IILS will be awarded.
8. How is this program different from other clinical research courses?
CPIP is uniquely designed for doctors, focusing on real-world case studies, PI responsibilities, and ICH-GCP-based learning rather than just theoretical concepts.
9. Will I get opportunities to work on clinical trials after this program?
The program enhances your eligibility and readiness to participate in clinical trials and collaborate with clinical trial sites, CROs, and pharmaceutical organizations.
10. How can I apply for the program?
You can apply online through our official platform. After application, candidates may undergo a counselling session or interview before final enrollment.
11. Is this program recognized by regulatory authorities?
The program is designed in alignment with global ICH-GCP guidelines and industry standards to ensure relevance and professional credibility.
12. Will I receive access to study materials and session recordings?
Why Choose CPIP at IILS?
Doctor-centric curriculum focused on Principal Investigator (PI) and Co-Investigator (Co-I) roles.
Practical, case-based learning with real-world clinical trial scenarios and regulatory insights.
Expert-led training by industry professionals with extensive clinical research and trial management experience.
Career and collaboration opportunities with clinical trial sites, CROs, and pharmaceutical organizations
