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INV48 · 48 h · Self-paced online

GCP for Investigators

For: Principal investigators and sub-investigators

A complete GCP course for investigators in India. The investigator is accountable for everything done at the site, so this course builds the judgement needed to supervise a team, protect participants and stay ready for monitoring, audit and inspection.

Who it is for

  • Principal investigators
  • Co-investigators and sub-investigators
  • Clinicians preparing to take on their first trial

What you will be able to do

  • Meet investigator qualification, resource and oversight duties under E6(R3) and the NDCT Rules
  • Work through the Indian approval pathway: CDSCO, ethics committees and CTRI registration
  • Obtain and document valid informed consent, including from vulnerable participants
  • Provide medical care, report safety events on time and handle compensation obligations
  • Manage investigational product, randomisation and unblinding correctly
  • Delegate safely, keep reliable records and respond to deviations, audits and inspections

Course content

12 units and 65 lessons. Times are planned study time, including the end-of-unit test.

  1. Unit 0

    Orientation & pre-test

    30 min

    1. 0.1How the course works5 min
    2. Pre-test (30 questions, ungraded)25 min

  2. Unit 1

    Foundations

    3 h 30 min

    1. 1.1Why ethical review and GCP exist; the Indian context40 min
    2. 1.2ICMR general principles45 min
    3. 1.3ICH E6(R3) principles of GCP45 min
    4. 1.4NDCT scope and definitions; how the three documents fit together40 min
    5. 1.5Scenarios: which framework applies?20 min
    6. Unit test: 10 questions, pass mark 70%20 min

  3. Unit 2

    The investigator

    4 h

    1. 2.1Who is an investigator; qualifications and training45 min
    2. 2.2Resources: time, staff, facilities, recruitment feasibility40 min
    3. 2.3Investigator responsibilities: E6(R3) and NDCT side by side50 min
    4. 2.4The investigator's undertaking30 min
    5. 2.5Responsible conduct, conflicts of interest, research misconduct35 min
    6. 2.6Case: should this PI take on another trial?20 min
    7. Unit test: 10 questions, pass mark 70%20 min

  4. Unit 3

    Approvals

    4 h 30 min

    1. 3.1The NDCT pathway: application (Form CT-04), Second Schedule, permission45 min
    2. 3.2Conditions of permission40 min
    3. 3.3Academic clinical trials; BA/BE studies40 min
    4. 3.4Working with the EC: submissions, communication, ongoing oversight45 min
    5. 3.5CTRI registration30 min
    6. 3.6Multicentre trials25 min
    7. 3.7Case: putting approvals in order before the first participant25 min
    8. Unit test: 10 questions, pass mark 70%20 min

  5. Unit 4

    Protocol, IB and trial design

    4 h

    1. 4.1Reading and critiquing the protocol50 min
    2. 4.2The Investigator's Brochure35 min
    3. 4.3Benefit-risk and ethical design45 min
    4. 4.4Protocol compliance and amendments40 min
    5. 4.5Feasibility, recruitment planning, payment to participants30 min
    6. 4.6Case: spot the protocol problems15 min
    7. Unit test: 12 questions, pass mark 70%25 min

  6. Unit 5

    Informed consent and vulnerable participants

    5 h 30 min

    1. 5.1Consent requirements55 min
    2. 5.2Conducting the consent discussion; LAR and impartial witness45 min
    3. 5.3Audio-video recording; e-consent35 min
    4. 5.4Children: parental consent and assent35 min
    5. 5.5Other vulnerable groups45 min
    6. 5.6Re-consent, withdrawal, waiver30 min
    7. 5.7Simulation: the consent conversation55 min
    8. Unit test: 15 questions, pass mark 70%30 min

  7. Unit 6

    Medical care, safety and compensation

    5 h 30 min

    1. 6.1Medical care of trial participants40 min
    2. 6.2AE and SAE: definitions and assessment45 min
    3. 6.3SAE reporting: 24 hours, reasons for delay, follow-up50 min
    4. 6.4Medical management and compensation55 min
    5. 6.5Unblinding for safety25 min
    6. 6.6Post-trial access25 min
    7. 6.7Workshop: an SAE at your site55 min
    8. Unit test: 18 questions, pass mark 70%35 min

  8. Unit 7

    Investigational product

    3 h 30 min

    1. 7.1IP management: receipt, storage, dispensing, accountability, return50 min
    2. 7.2Randomisation and unblinding procedures40 min
    3. 7.3Import licence and labelling of trial drugs (awareness)30 min
    4. 7.4Direct-to-participant IP delivery30 min
    5. 7.5Case: temperature excursion30 min
    6. Unit test: 15 questions, pass mark 70%30 min

  9. Unit 8

    Delegation, oversight, records and data

    4 h 30 min

    1. 8.1Delegation and supervision; service providers50 min
    2. 8.2Training the site team30 min
    3. 8.3Source and essential records50 min
    4. 8.4Data governance for investigators45 min
    5. 8.5Reports to the EC, sponsor and regulator30 min
    6. 8.6Privacy and confidentiality30 min
    7. Unit test: 18 questions, pass mark 70%35 min

  10. Unit 9

    Compliance

    4 h

    1. 9.1Deviations and non-compliance40 min
    2. 9.2Monitoring and audits: what to expect40 min
    3. 9.3Regulatory inspections45 min
    4. 9.4Suspension, termination, end of participation35 min
    5. 9.5Reporting and publishing results30 min
    6. 9.6Case: are you inspection-ready?25 min
    7. Unit test: 12 questions, pass mark 70%25 min

  11. Unit 10

    Special trial types and decentralised elements

    4 h

    1. 10.1Decentralised elements and investigator oversight55 min
    2. 10.2Pragmatic trials and real-world data (awareness)30 min
    3. 10.3Special trial types: devices, biologicals, stem cells, oncology, traditional medicine, HIV, surgery50 min
    4. 10.4Genetics, biobanking and datasets35 min
    5. 10.5Research in emergencies25 min
    6. 10.6Public health and social/behavioural research25 min
    7. Unit test: 10 questions, pass mark 70%20 min

  12. Unit 11

    Capstone: running a trial at your site

    3 h

    1. 11.1Start-up decisions: feasibility, team, delegation, approvals1 h
    2. 11.2Mid-trial problems: a consent issue, an SAE, repeated deviations1 h
    3. 11.3Inspection interview: answer the inspector's questions from your records1 h

  13. Final

    Final exam

    1 h 30 min

How you are assessed

Every component must be passed to receive the certificate.

Pre-test

30 questions in 25 minutes. Not graded: it records your starting point so you can see how much you have learned.

Unit tests

A test at the end of each of 10 teaching units, pass mark 70%, up to 3 attempts.

Capstone

A graded, role-based exercise: running a trial at your site. Pass mark 70%.

Final exam

75 questions in 90 minutes, at least 50% scenario-based. Pass mark 80%; up to 3 attempts, 24 hours apart.

Certificate

Pass every component to receive a certificate of completion with a unique verification ID (for example GCP-INV48-…). It is valid for 3 years, and anyone can confirm it on our verification page.

Sample: learning outcomes from lesson 0.1

How the course works

  • Describe the structure of the course and how progress is assessed
  • Explain how the three source documents are cited in every lesson

Every lesson opens with outcomes like these and ends with a short knowledge check.

Other courses

The same foundation, focused on a different role.

Enrol in GCP for Investigators

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Enrol in GCP for Investigators