INV48 · 48 hours

GCP for Investigators

For principal investigators and sub-investigators.

Assessment

• An ungraded pre-test (30 questions) at the start.
• A test at the end of each unit; pass mark 70%.
• A scored capstone exercise.
• A final exam: 75 questions in 90 minutes; pass mark 80%.
• A certificate with a public verification ID, valid for 3 years.

Course outline

1. Unit 0: Orientation & pre-test (1 lesson)

   • 0.1 How the course works · 5 min
2. Unit 1: Foundations (5 lessons)

   • 1.1 Why ethical review and GCP exist; the Indian context · 40 min
   • 1.2 ICMR general principles · 45 min
   • 1.3 ICH E6(R3) principles of GCP · 45 min
   • 1.4 NDCT scope and definitions; how the three documents fit together · 40 min
   • 1.5 Scenarios: which framework applies? · 20 min
3. Unit 2: The investigator (6 lessons)

   • 2.1 Who is an investigator; qualifications and training · 45 min
   • 2.2 Resources: time, staff, facilities, recruitment feasibility · 40 min
   • 2.3 Investigator responsibilities: E6(R3) and NDCT side by side · 50 min
   • 2.4 The investigator's undertaking · 30 min
   • 2.5 Responsible conduct, conflicts of interest, research misconduct · 35 min
   • 2.6 Case: should this PI take on another trial? · 20 min
4. Unit 3: Approvals (7 lessons)

   • 3.1 The NDCT pathway: application (Form CT-04), Second Schedule, permission · 45 min
   • 3.2 Conditions of permission · 40 min
   • 3.3 Academic clinical trials; BA/BE studies · 40 min
   • 3.4 Working with the EC: submissions, communication, ongoing oversight · 45 min
   • 3.5 CTRI registration · 30 min
   • 3.6 Multicentre trials · 25 min
   • 3.7 Case: putting approvals in order before the first participant · 25 min
5. Unit 4: Protocol, IB and trial design (6 lessons)

   • 4.1 Reading and critiquing the protocol · 50 min
   • 4.2 The Investigator's Brochure · 35 min
   • 4.3 Benefit-risk and ethical design · 45 min
   • 4.4 Protocol compliance and amendments · 40 min
   • 4.5 Feasibility, recruitment planning, payment to participants · 30 min
   • 4.6 Case: spot the protocol problems · 15 min
6. Unit 5: Informed consent and vulnerable participants (7 lessons)

   • 5.1 Consent requirements · 55 min
   • 5.2 Conducting the consent discussion; LAR and impartial witness · 45 min
   • 5.3 Audio-video recording; e-consent · 35 min
   • 5.4 Children: parental consent and assent · 35 min
   • 5.5 Other vulnerable groups · 45 min
   • 5.6 Re-consent, withdrawal, waiver · 30 min
   • 5.7 Simulation: the consent conversation · 55 min
7. Unit 6: Medical care, safety and compensation (7 lessons)

   • 6.1 Medical care of trial participants · 40 min
   • 6.2 AE and SAE: definitions and assessment · 45 min
   • 6.3 SAE reporting: 24 hours, reasons for delay, follow-up · 50 min
   • 6.4 Medical management and compensation · 55 min
   • 6.5 Unblinding for safety · 25 min
   • 6.6 Post-trial access · 25 min
   • 6.7 Workshop: an SAE at your site · 55 min
8. Unit 7: Investigational product (5 lessons)

   • 7.1 IP management: receipt, storage, dispensing, accountability, return · 50 min
   • 7.2 Randomisation and unblinding procedures · 40 min
   • 7.3 Import licence and labelling of trial drugs (awareness) · 30 min
   • 7.4 Direct-to-participant IP delivery · 30 min
   • 7.5 Case: temperature excursion · 30 min
9. Unit 8: Delegation, oversight, records and data (6 lessons)

   • 8.1 Delegation and supervision; service providers · 50 min
   • 8.2 Training the site team · 30 min
   • 8.3 Source and essential records · 50 min
   • 8.4 Data governance for investigators · 45 min
   • 8.5 Reports to the EC, sponsor and regulator · 30 min
   • 8.6 Privacy and confidentiality · 30 min
10. Unit 9: Compliance (6 lessons)

    • 9.1 Deviations and non-compliance · 40 min
    • 9.2 Monitoring and audits: what to expect · 40 min
    • 9.3 Regulatory inspections · 45 min
    • 9.4 Suspension, termination, end of participation · 35 min
    • 9.5 Reporting and publishing results · 30 min
    • 9.6 Case: are you inspection-ready? · 25 min
11. Unit 10: Special trial types and decentralised elements (6 lessons)

    • 10.1 Decentralised elements and investigator oversight · 55 min
    • 10.2 Pragmatic trials and real-world data (awareness) · 30 min
    • 10.3 Special trial types: devices, biologicals, stem cells, oncology, traditional medicine, HIV, surgery · 50 min
    • 10.4 Genetics, biobanking and datasets · 35 min
    • 10.5 Research in emergencies · 25 min
    • 10.6 Public health and social/behavioural research · 25 min
12. Unit 11: Capstone: running a trial at your site (3 lessons)

    • 11.1 Start-up decisions: feasibility, team, delegation, approvals · 60 min
    • 11.2 Mid-trial problems: a consent issue, an SAE, repeated deviations · 60 min
    • 11.3 Inspection interview: answer the inspector's questions from your records · 60 min