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CRC48 · 48 h · Self-paced online

GCP for Clinical Research Coordinators

For: Clinical research coordinators and site staff

A complete GCP course for clinical research coordinators and site staff in India. A coordinator carries out tasks the investigator has delegated, and the investigator stays responsible. The course teaches GCP duties from the point of view of the person doing the work, and is clear about what must not be done without proper delegation and training.

Who it is for

  • Clinical research coordinators
  • Study nurses
  • Site research staff and site managers

What you will be able to do

  • Explain the coordinator role, delegation and the limits of delegated work
  • Prepare a site for study start-up and keep essential records in order
  • Support recruitment, screening and the informed consent process
  • Run study visits to protocol and recognise and record deviations
  • Identify, record and escalate safety events within required timelines
  • Keep source documents and CRFs accurate, and prepare for monitoring, audits and inspections

Course content

12 units and 59 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 CRC role

    3 h 30 min

    1. 2.1Where the CRC fits: investigator, sponsor, EC, monitor40 min
    2. 2.2Delegation: what can be delegated; the delegation log45 min
    3. 2.3Qualifications and training records30 min
    4. 2.4Ethics in daily practice: respect, confidentiality, conflicts of interest35 min
    5. 2.5Case: a task you should not accept30 min
    6. Unit test: 15 questions, pass mark 70%30 min

  4. Unit 3

    Study start-up

    5 h

    1. 3.1Approvals before the first participant: CDSCO permission, EC approval, CTRI45 min
    2. 3.2Preparing EC submissions and tracking approvals50 min
    3. 3.3Investigator site file and essential records50 min
    4. 3.4Site readiness and site initiation40 min
    5. 3.5Insurance and compensation arrangements: what the site should hold30 min
    6. 3.6Workshop: build a start-up checklist55 min
    7. Unit test: 15 questions, pass mark 70%30 min

  5. Unit 4

    Recruitment, screening and informed consent

    6 h

    1. 4.1Ethical recruitment, advertisements, payments40 min
    2. 4.2Screening and eligibility documentation40 min
    3. 4.3Consent requirements55 min
    4. 4.4Consent logistics: versions, translations, LAR, impartial witness, copies45 min
    5. 4.5Audio-video recording in practice; e-consent40 min
    6. 4.6Vulnerable participants, incl. children45 min
    7. 4.7Simulation: a consent visit1 h
    8. Unit test: 18 questions, pass mark 70%35 min

  6. Unit 5

    Study visits and protocol compliance

    4 h

    1. 5.1Visit schedule and protocol procedures45 min
    2. 5.2Deviations: prevent, document, report45 min
    3. 5.3Participant care, retention and withdrawal40 min
    4. 5.4Amendments and re-consent30 min
    5. 5.5Case: a missed visit window50 min
    6. Unit test: 15 questions, pass mark 70%30 min

  7. Unit 6

    Safety

    5 h

    1. 6.1AE and SAE definitions40 min
    2. 6.2Capturing AEs at visits; source documentation40 min
    3. 6.3The SAE workflow and the 24-hour clock50 min
    4. 6.4Medical management and the compensation process45 min
    5. 6.5Emergency unblinding procedure25 min
    6. 6.6Workshop: an SAE in 24 hours1 h
    7. Unit test: 20 questions, pass mark 70%40 min

  8. Unit 7

    Investigational product

    3 h 30 min

    1. 7.1Receiving and storing IP; temperature logs45 min
    2. 7.2Dispensing, accountability and returns45 min
    3. 7.3Randomisation systems30 min
    4. 7.4Direct-to-participant IP delivery25 min
    5. 7.5Case: an accountability discrepancy35 min
    6. Unit test: 15 questions, pass mark 70%30 min

  9. Unit 8

    Source documents, CRFs, data quality and privacy

    5 h 30 min

    1. 8.1Source documents: what counts as source50 min
    2. 8.2CRF completion and data corrections45 min
    3. 8.3Data governance, metadata and audit trails50 min
    4. 8.4Query resolution35 min
    5. 8.5Maintaining and retaining essential records45 min
    6. 8.6Privacy and confidentiality35 min
    7. 8.7Workshop: find the documentation errors40 min
    8. Unit test: 15 questions, pass mark 70%30 min

  10. Unit 9

    Monitoring, audits, inspections, close-out

    4 h 30 min

    1. 9.1Preparing for monitoring visits45 min
    2. 9.2Audits30 min
    3. 9.3Regulatory inspections45 min
    4. 9.4Status reports and notifications35 min
    5. 9.5Close-out and archiving40 min
    6. 9.6Case: an inspection walkthrough45 min
    7. Unit test: 15 questions, pass mark 70%30 min

  11. Unit 10

    Decentralised elements and special trial types

    2 h 30 min

    1. 10.1Decentralised elements: remote visits, local healthcare providers45 min
    2. 10.2Special trial types relevant to sites40 min
    3. 10.3Academic and investigator-initiated trials45 min
    4. Unit test: 10 questions, pass mark 70%20 min

  12. Unit 11

    Capstone: a week at the site

    3 h

    1. 11.1Screening and consent day1 h
    2. 11.2An SAE and an IP problem on the same day1 h
    3. 11.3Monitoring-visit preparation and query resolution1 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: a week at the 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-CRC48-…). 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 Clinical Research Coordinators

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Enrol in GCP for Clinical Research Coordinators