CRA48 · 48 hours

GCP for Clinical Research Associates

For clinical research associates and monitors.

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: Sponsor and CRO responsibilities; the CRA role (6 lessons)

   • 2.1 Sponsor responsibilities: E6(R3) and NDCT side by side · 50 min
   • 2.2 Trial design and resources · 30 min
   • 2.3 Allocating activities to CROs; agreements; CRO registration in India · 45 min
   • 2.4 Qualification, training, medical expertise, financing · 30 min
   • 2.5 Sponsor oversight · 40 min
   • 2.6 The CRA role: qualifications and conduct of monitors · 45 min
4. Unit 3: Regulatory pathway and start-up (7 lessons)

   • 3.1 NDCT application and permission · 45 min
   • 3.2 Conditions of permission · 40 min
   • 3.3 Investigator and site selection; feasibility · 40 min
   • 3.4 Communication with ECs and the regulator; multicentre review · 40 min
   • 3.5 CTRI registration · 20 min
   • 3.6 The site initiation visit · 40 min
   • 3.7 Case: the site is not ready · 20 min
5. Unit 4: Quality management and risk-based approaches (6 lessons)

   • 4.1 Quality by design and critical-to-quality factors · 50 min
   • 4.2 The risk management process · 50 min
   • 4.3 Quality assurance and quality control · 40 min
   • 4.4 Choosing a risk-proportionate monitoring strategy · 45 min
   • 4.5 NDCT First Schedule: general principles and methodology · 30 min
   • 4.6 Workshop: a risk assessment for a protocol · 55 min
6. Unit 5: Monitoring (7 lessons)

   • 5.1 The monitoring plan and visit types · 50 min
   • 5.2 On-site, remote and centralised monitoring · 50 min
   • 5.3 Source data verification and review: what to check · 50 min
   • 5.4 Reviewing essential records and site files · 45 min
   • 5.5 Monitoring reports and follow-up letters · 45 min
   • 5.6 Communicating findings and escalation · 30 min
   • 5.7 Simulation: a monitoring visit · 60 min
7. Unit 6: Monitoring consent and participant protection (5 lessons)

   • 6.1 Consent requirements a monitor verifies · 55 min
   • 6.2 Verifying audio-video recording of consent · 30 min
   • 6.3 Vulnerable participants · 40 min
   • 6.4 Eligibility and participant safety checks · 40 min
   • 6.5 Case: consent findings at a site · 45 min
8. Unit 7: Safety oversight (6 lessons)

   • 7.1 Safety definitions and sponsor review of safety information · 45 min
   • 7.2 SAE flow and timelines: investigator, sponsor, EC, regulator · 50 min
   • 7.3 Managing an immediate hazard · 25 min
   • 7.4 Compensation and medical management: sponsor obligations · 55 min
   • 7.5 Monitoring safety at sites: finding unreported AEs · 35 min
   • 7.6 Workshop: reconcile site and safety-database SAEs · 35 min
9. Unit 8: Investigational product and data oversight (7 lessons)

   • 8.1 IP information, supply and handling; import and labelling · 45 min
   • 8.2 Monitoring IP accountability and blinding · 40 min
   • 8.3 Data handling, statistical programming and analysis (awareness) · 35 min
   • 8.4 Data governance and computerised systems · 50 min
   • 8.5 Record keeping, retention and access · 30 min
   • 8.6 Privacy and confidentiality · 25 min
   • 8.7 Case: a data integrity finding · 20 min
10. Unit 9: Non-compliance, audits, inspections, close-out (6 lessons)

    • 9.1 Non-compliance and its consequences · 45 min
    • 9.2 Audits · 35 min
    • 9.3 Regulatory inspections · 40 min
    • 9.4 Suspension and premature termination · 30 min
    • 9.5 Close-out, status reports and the clinical study report · 35 min
    • 9.6 Post-trial access · 20 min
11. Unit 10: Annex 2: decentralised elements and real-world data (3 lessons)

    • 10.1 Sponsor considerations: engagement, design, EC communication · 45 min
    • 10.2 Real-world data and remote data collection · 45 min
    • 10.3 Overseeing decentralised activities: IP, oversight, safety · 40 min
12. Unit 11: Capstone: a monitoring cycle (3 lessons)

    • 11.1 Pre-visit preparation from centralised data and risk indicators · 60 min
    • 11.2 Simulated site visit: find and grade the issues · 60 min
    • 11.3 Write the monitoring report and follow-up letter · 60 min