GCP for Clinical Research Associates

Course content

12 units and 62 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

   Sponsor and CRO responsibilities; the CRA role

   4 h 30 min

   1. 2.1Sponsor responsibilities: E6(R3) and NDCT side by side50 min
   2. 2.2Trial design and resources30 min
   3. 2.3Allocating activities to CROs; agreements; CRO registration in India45 min
   4. 2.4Qualification, training, medical expertise, financing30 min
   5. 2.5Sponsor oversight40 min
   6. 2.6The CRA role: qualifications and conduct of monitors45 min
   7. Unit test: 15 questions, pass mark 70%30 min

4. Unit 3

   Regulatory pathway and start-up

   4 h 30 min

   1. 3.1NDCT application and permission45 min
   2. 3.2Conditions of permission40 min
   3. 3.3Investigator and site selection; feasibility40 min
   4. 3.4Communication with ECs and the regulator; multicentre review40 min
   5. 3.5CTRI registration20 min
   6. 3.6The site initiation visit40 min
   7. 3.7Case: the site is not ready20 min
   8. Unit test: 12 questions, pass mark 70%25 min

5. Unit 4

   Quality management and risk-based approaches

   5 h

   1. 4.1Quality by design and critical-to-quality factors50 min
   2. 4.2The risk management process50 min
   3. 4.3Quality assurance and quality control40 min
   4. 4.4Choosing a risk-proportionate monitoring strategy45 min
   5. 4.5NDCT First Schedule: general principles and methodology30 min
   6. 4.6Workshop: a risk assessment for a protocol55 min
   7. Unit test: 15 questions, pass mark 70%30 min

6. Unit 5

   Monitoring

   6 h

   1. 5.1The monitoring plan and visit types50 min
   2. 5.2On-site, remote and centralised monitoring50 min
   3. 5.3Source data verification and review: what to check50 min
   4. 5.4Reviewing essential records and site files45 min
   5. 5.5Monitoring reports and follow-up letters45 min
   6. 5.6Communicating findings and escalation30 min
   7. 5.7Simulation: a monitoring visit1 h
   8. Unit test: 15 questions, pass mark 70%30 min

7. Unit 6

   Monitoring consent and participant protection

   4 h

   1. 6.1Consent requirements a monitor verifies55 min
   2. 6.2Verifying audio-video recording of consent30 min
   3. 6.3Vulnerable participants40 min
   4. 6.4Eligibility and participant safety checks40 min
   5. 6.5Case: consent findings at a site45 min
   6. Unit test: 15 questions, pass mark 70%30 min

8. Unit 7

   Safety oversight

   4 h 30 min

   1. 7.1Safety definitions and sponsor review of safety information45 min
   2. 7.2SAE flow and timelines: investigator, sponsor, EC, regulator50 min
   3. 7.3Managing an immediate hazard25 min
   4. 7.4Compensation and medical management: sponsor obligations55 min
   5. 7.5Monitoring safety at sites: finding unreported AEs35 min
   6. 7.6Workshop: reconcile site and safety-database SAEs35 min
   7. Unit test: 12 questions, pass mark 70%25 min

9. Unit 8

   Investigational product and data oversight

   4 h 30 min

   1. 8.1IP information, supply and handling; import and labelling45 min
   2. 8.2Monitoring IP accountability and blinding40 min
   3. 8.3Data handling, statistical programming and analysis (awareness)35 min
   4. 8.4Data governance and computerised systems50 min
   5. 8.5Record keeping, retention and access30 min
   6. 8.6Privacy and confidentiality25 min
   7. 8.7Case: a data integrity finding20 min
   8. Unit test: 12 questions, pass mark 70%25 min

10. Unit 9

    Non-compliance, audits, inspections, close-out

    4 h

    1. 9.1Non-compliance and its consequences45 min
    2. 9.2Audits35 min
    3. 9.3Regulatory inspections40 min
    4. 9.4Suspension and premature termination30 min
    5. 9.5Close-out, status reports and the clinical study report35 min
    6. 9.6Post-trial access20 min
    7. Unit test: 18 questions, pass mark 70%35 min

11. Unit 10

    Annex 2: decentralised elements and real-world data

    2 h 30 min

    1. 10.1Sponsor considerations: engagement, design, EC communication45 min
    2. 10.2Real-world data and remote data collection45 min
    3. 10.3Overseeing decentralised activities: IP, oversight, safety40 min
    4. Unit test: 10 questions, pass mark 70%20 min

12. Unit 11

    Capstone: a monitoring cycle

    3 h

    1. 11.1Pre-visit preparation from centralised data and risk indicators1 h
    2. 11.2Simulated site visit: find and grade the issues1 h
    3. 11.3Write the monitoring report and follow-up letter1 h

13. Final

    Final exam

    1 h 30 min