CRC48 · 48 hours

GCP for Clinical Research Coordinators

For clinical research coordinators and site staff.

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 CRC role (5 lessons)

   • 2.1 Where the CRC fits: investigator, sponsor, EC, monitor · 40 min
   • 2.2 Delegation: what can be delegated; the delegation log · 45 min
   • 2.3 Qualifications and training records · 30 min
   • 2.4 Ethics in daily practice: respect, confidentiality, conflicts of interest · 35 min
   • 2.5 Case: a task you should not accept · 30 min
4. Unit 3: Study start-up (6 lessons)

   • 3.1 Approvals before the first participant: CDSCO permission, EC approval, CTRI · 45 min
   • 3.2 Preparing EC submissions and tracking approvals · 50 min
   • 3.3 Investigator site file and essential records · 50 min
   • 3.4 Site readiness and site initiation · 40 min
   • 3.5 Insurance and compensation arrangements: what the site should hold · 30 min
   • 3.6 Workshop: build a start-up checklist · 55 min
5. Unit 4: Recruitment, screening and informed consent (7 lessons)

   • 4.1 Ethical recruitment, advertisements, payments · 40 min
   • 4.2 Screening and eligibility documentation · 40 min
   • 4.3 Consent requirements · 55 min
   • 4.4 Consent logistics: versions, translations, LAR, impartial witness, copies · 45 min
   • 4.5 Audio-video recording in practice; e-consent · 40 min
   • 4.6 Vulnerable participants, incl. children · 45 min
   • 4.7 Simulation: a consent visit · 60 min
6. Unit 5: Study visits and protocol compliance (5 lessons)

   • 5.1 Visit schedule and protocol procedures · 45 min
   • 5.2 Deviations: prevent, document, report · 45 min
   • 5.3 Participant care, retention and withdrawal · 40 min
   • 5.4 Amendments and re-consent · 30 min
   • 5.5 Case: a missed visit window · 50 min
7. Unit 6: Safety (6 lessons)

   • 6.1 AE and SAE definitions · 40 min
   • 6.2 Capturing AEs at visits; source documentation · 40 min
   • 6.3 The SAE workflow and the 24-hour clock · 50 min
   • 6.4 Medical management and the compensation process · 45 min
   • 6.5 Emergency unblinding procedure · 25 min
   • 6.6 Workshop: an SAE in 24 hours · 60 min
8. Unit 7: Investigational product (5 lessons)

   • 7.1 Receiving and storing IP; temperature logs · 45 min
   • 7.2 Dispensing, accountability and returns · 45 min
   • 7.3 Randomisation systems · 30 min
   • 7.4 Direct-to-participant IP delivery · 25 min
   • 7.5 Case: an accountability discrepancy · 35 min
9. Unit 8: Source documents, CRFs, data quality and privacy (7 lessons)

   • 8.1 Source documents: what counts as source · 50 min
   • 8.2 CRF completion and data corrections · 45 min
   • 8.3 Data governance, metadata and audit trails · 50 min
   • 8.4 Query resolution · 35 min
   • 8.5 Maintaining and retaining essential records · 45 min
   • 8.6 Privacy and confidentiality · 35 min
   • 8.7 Workshop: find the documentation errors · 40 min
10. Unit 9: Monitoring, audits, inspections, close-out (6 lessons)

    • 9.1 Preparing for monitoring visits · 45 min
    • 9.2 Audits · 30 min
    • 9.3 Regulatory inspections · 45 min
    • 9.4 Status reports and notifications · 35 min
    • 9.5 Close-out and archiving · 40 min
    • 9.6 Case: an inspection walkthrough · 45 min
11. Unit 10: Decentralised elements and special trial types (3 lessons)

    • 10.1 Decentralised elements: remote visits, local healthcare providers · 45 min
    • 10.2 Special trial types relevant to sites · 40 min
    • 10.3 Academic and investigator-initiated trials · 45 min
12. Unit 11: Capstone: a week at the site (3 lessons)

    • 11.1 Screening and consent day · 60 min
    • 11.2 An SAE and an IP problem on the same day · 60 min
    • 11.3 Monitoring-visit preparation and query resolution · 60 min