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iLearn CRI
1 month · Offline / Online

ICH-GCP Certification Course in Pune

1-month ICH-GCP Certification Course in Pune at iLearn CRI covering E6(R3): the 13 core principles, informed consent, essential documents, ALCOA+ data integrity, and the New Drugs and Clinical Trials Rules 2019. ₹15,000 + GST (EMI available) with Offline & online batches for freshers and working professionals.

Duration
1 month
Mode
Offline / Online
Fees
₹15K
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A focused, affordable GCP credential

Good Clinical Practice is the one certificate every clinical research employer expects to see. Whether you are a fresher building your first profile or a working professional at a CRO, hospital, or site, a current ICH-GCP certificate signals that you understand the ethical and quality standard that governs every clinical trial. The ICH-GCP Certification Course at iLearn CRI is a short, one-month programme built to give you exactly that — a recognised, up-to-date GCP credential without a long time or cost commitment.

The course teaches ICH-GCP E6(R3) in depth: the 13 core principles, the history and purpose of GCP, the Declaration of Helsinki, the roles and responsibilities of sponsor, investigator, monitor and IRB/IEC, the informed consent process, essential documents and the Trial Master File, protocol compliance and deviations, safety reporting, ALCOA+ data integrity, audits and inspections, and the New Drugs and Clinical Trials Rules 2019 that govern trials in India.

Pune is a strong place to earn this credential. The Hinjewadi-Wakad-Bhosari corridor houses clinical operations for CROs including Syngene, Veeda Clinical Research, Lambda Therapeutic Research, IQVIA, ICON, and Parexel, alongside pharma sponsors Cipla, Sun Pharma, and Lupin — all of whom expect a current GCP foundation from the people they hire.

What you will learn

The course is built around the GCP knowledge that employers, auditors, and inspectors actually expect on the job.

The foundations and 13 core principles. You learn the history and purpose of GCP, the Declaration of Helsinki, and how E6(R3) updates the earlier guideline — then work through all 13 core principles so you can apply them, not just recite them.

Roles, responsibilities, and informed consent. You build a clear command of what the sponsor, investigator, monitor, and IRB/IEC are each accountable for, and you learn the informed consent process end to end — the single most scrutinised area in any trial.

Essential documents and data integrity. You learn the essential document set, how the Trial Master File is structured and maintained, and the ALCOA+ principles that keep trial data reliable across increasingly digital studies.

Compliance, safety, and inspections. You learn how protocol deviations are handled, how adverse and serious adverse events are reported, and how audits and regulatory inspections work — mapped to the New Drugs and Clinical Trials Rules 2019 in India.

How the course is structured

The ICH-GCP course runs over one month in both offline (classroom) and online batches, so you can attend in person at our Wakad campus or join live from anywhere in India. Weekday-evening and weekend batches are available so working professionals can complete the certificate without disrupting their job.

Faculty are practising clinical research professionals — CRAs, drug safety scientists, and site coordinators — who teach E6(R3) through real trial situations rather than abstract theory. Assessment is straightforward, and you receive your iLearn CRI Certificate in ICH-GCP on completion.

Why this certificate matters

GCP is not an optional extra in clinical research — it is the baseline expectation. For working professionals at CROs, hospitals, and sites, a current E6(R3) certificate keeps your profile compliant and inspection-ready. For freshers, it is an affordable, recognised credential that strengthens an entry-level application and demonstrates you already understand the standard your future employer works to every day. The certificate on its own supports roles such as Clinical Research Coordinator, Site Coordinator, and Ethics Committee Coordinator, and it complements the fuller training a specialisation demands.

Who this course is right for

You will get the most out of the ICH-GCP course if you are:

  • A working professional in clinical research, a CRO, a hospital, or a site who needs a recognised, current GCP certificate
  • A fresh graduate (B.Pharm, M.Pharm, B.Sc, M.Sc, BDS, MBBS, BHMS, BAMS, BPT, nursing) who wants an affordable credential to strengthen an entry-level profile
  • A research nurse or coordinator who wants formal GCP training aligned to E6(R3)
  • Someone who wants a quick top-up before or alongside a full clinical research programme

Apply for the next batch

Batches start every month, with limited seats per batch to protect faculty attention and the quality of instruction. Early applicants get priority for their preferred offline or online intake.

Reach out via WhatsApp for an immediate conversation about your background and the right intake batch for you.

If you want more depth or a specific specialisation, the natural next steps are:

Further reading

Online & classroom

Available online and in the classroom

The ICH-GCP course runs as two separate batches — a live online batch and an offline classroom batch at our Wakad campus — so you can train from anywhere in India or attend in person in Pune. Both run weekday evenings and full Saturdays, and both are fully instructor-led by practicing professionals.

Live online batch

Fully instructor-led live sessions with independent remote hands-on access to the same platforms (Argus, Medidata Rave, eCTD tools) and the same placement support — so you build a real portfolio from home. Designed for students across India and working professionals who can't relocate to Pune.

Classroom batch (Pune)

In-person at our Wakad campus in the Hinjewadi-Wakad corridor, with hands-on lab access and face-to-face faculty time — ideal for Pune-based students who want maximum platform practice.

Not sure which batch suits you? Talk to admissions about the current schedule, or see all online clinical research courses.

Curriculum

What you’ll learn, module by module.

  1. 01 Foundations & History of GCP
    • History and purpose of Good Clinical Practice
    • The Declaration of Helsinki and its ethical foundations
    • What ICH-GCP E6(R3) is and how it updates E6(R2)
    • The 13 core principles of ICH-GCP
  2. 02 Roles & Responsibilities
    • Sponsor responsibilities and oversight obligations
    • Investigator responsibilities and delegation of duties
    • Monitor (CRA) responsibilities and monitoring approaches
    • IRB/IEC composition, functions, and responsibilities
  3. 03 Informed Consent & Ethics in Practice
    • The informed consent process, elements, and documentation
    • Consent in vulnerable populations and emergency situations
    • Re-consent following protocol or safety updates
    • Ethical review, approvals, and continuing oversight
  4. 04 Essential Documents & the Trial Master File
    • The essential document set and why each is required
    • Structure and maintenance of the Trial Master File (TMF)
    • Protocol, Investigator's Brochure, and source documentation
    • ALCOA+ data integrity principles in practice
  5. 05 Protocol Compliance & Safety Reporting
    • Protocol compliance, deviations, and corrective actions
    • Adverse events, serious adverse events, and SUSAR reporting
    • Safety reporting timelines and sponsor/investigator duties
    • Quality management and risk-based thinking under E6(R3)
  6. 06 Audits, Inspections & Indian Regulations
    • Sponsor audits and regulatory inspections — how to prepare
    • Inspection readiness at the site and common findings
    • The New Drugs and Clinical Trials Rules 2019 (India)
    • CDSCO oversight and how GCP maps to Indian requirements
Career outcomes

Roles graduates step into.

  • Clinical Research Coordinator (CRC)
    Avg. CTC ₹ 3.0–4.0 LPA
  • Clinical Trial Assistant (CTA)
    Avg. CTC ₹ 3.0–4.0 LPA
  • Site Coordinator
    Avg. CTC ₹ 3.0–4.0 LPA
  • Research Nurse
    Avg. CTC ₹ 3.5–4.5 LPA
  • Ethics Committee Coordinator
    Avg. CTC ₹ 3.5–4.5 LPA
Placements

Where clinical research careers start in Pune.

Our placement record reflects what most clinical research institutes in Pune don’t measure: not just where you start, but how fast you grow inside pharma and CROs.

Alumni Working Across Pharma
50+

Alumni Working Across Pharma & CRO Industry

Average Industry Starting CTC
₹4.2L

Average Industry Starting CTC

Placement Assistance Support
100%

Placement Assistance Support

Pharma & CRO Hiring
50+

Pharma & CRO Hiring Partners

See full placement record
FAQ

Questions about the ICH-GCP

Can’t find your answer? Reach out on WhatsApp—we usually reply within an hour during business days.

Ask on WhatsApp →
What is the fee for the ICH-GCP Certification Course in Pune?

The 1-month ICH-GCP Certification Course at iLearn CRI in Pune is ₹15,000 + 18% GST. The fee covers all course materials, E6(R3) training, and your certificate of completion. EMI options are available. As a short, affordable credential it is one of the most cost-effective ways to add a recognised GCP certificate to your profile.

Is the ICH-GCP course available online or only offline?

Both. The ICH-GCP course runs in offline (classroom) and online modes, so you can attend in person at our Wakad, Pune campus or join live from anywhere in India. Both modes follow the same E6(R3) curriculum, the same faculty, and the same assessment. Working professionals usually choose the online batch so they can complete the certificate without leaving their current job.

Is this GCP course enough on its own, or should I take a full clinical research course?

It depends on your goal. If you already work in clinical research, a CRO, a hospital, or a site and simply need a recognised GCP credential, this 1-month certificate is enough on its own. If you are a fresher trying to enter the industry, GCP is essential but not sufficient — you will also need trial phases, regulatory framework, monitoring, and placement preparation, which our Certificate or PG Diploma in Clinical Research provide. Many freshers take ICH-GCP as a first step and then progress to a full programme.

What is ICH-GCP E6(R3)?

ICH-GCP E6(R3) is the latest revision of the International Council for Harmonisation's Good Clinical Practice guideline — the international ethical and scientific quality standard for designing, conducting, recording, and reporting clinical trials. E6(R3) modernises the earlier E6(R2) with a stronger emphasis on quality by design, risk-based and proportionate approaches, and data integrity across increasingly digital trials. This course teaches E6(R3) in depth, including its 13 core principles.

Who should take the ICH-GCP Certification Course?

The course suits B.Pharm, M.Pharm, B.Sc, M.Sc, BDS, MBBS, BHMS, BAMS, BPT, and nursing graduates, as well as working professionals in clinical research, CROs, hospitals, or sites who need a recognised GCP certificate. It works both as a standalone credential for those already in the field and as an affordable top-up for freshers building an entry-level profile.

Will I receive a certificate, and is it recognised?

Yes. You receive an iLearn CRI Certificate in ICH-GCP on completion. The curriculum is aligned to ICH-GCP E6(R3) and the New Drugs and Clinical Trials Rules 2019, so it is respected by CROs and pharma sponsors across Pune's clinical research corridor who expect a current GCP foundation from every candidate they hire.