By the end of this learning event, you will be able to:

  • Plan GCP inspections considering risk factors of the trials
  • Conduct a risk based GCP inspection
  • Arrive at regulatory decisions with regards to compliance of the study with GCP standard
  • Report the outcome to the sponsor/clinical trial site.

The learning comprises of six sessions with its specific objectives to be met, and built on another. Therefore, the objectives of the course are then placed into 16 objectives to be covered within 24 weeks. At the end of the course, participants will be able to:

  1. Explain GCP guidelines and each principle
  2. Define the process of clinical trials and key activities involved in a clinical trial
  3. Given four case studies, conclude on risks that may impact on incompliance with GCP principles.
  4. Explain the quality in the context of a clinical trial
  5. Explain the elements of a quality management system for GCP inspection
  6. Given case studies on trial management, evaluate the handling of investigational products, interactive response system, randomization and blinding procedures, and serious adverse events
  7. Given a protocol, identify the consequence of protocol deviation, referring each section in a protocol
  8. define hazard, harm, likelihood, severity, detectability, risk, and different nature control measures and explain their relation to each other
  9. given a scenario, develop a risk question and conduct preliminary risk assessment
  10. given four non-conformance situations in the conduct of clinical trial, identify and decide priority inspections to minimize risk
  11. Create a checklist describing activities to be conducted prior to an inspection
  12. Use different questioning techniques
  13. Given a list of documents, discuss why they are needed prior to an inspection
  14. Given two case scenarios on interviewing staff during an inspection, based on the response you receive from the research team staff:
    1. define questioning styles inspectors used
    2. decide on your next move
    3. select type of noncompliance with GCP principles if any (and identify which principle it violates)
    4. categorize your observation for citation.
  15. Decide on the inconsistencies with GCP principles including relevant articles in given scenarios on:
    1. delegation of work
    2. ethics committee
    3. taking informed consent
    4. archiving documents
    5. witnesses for informed consent
    6. temperature control records of the investigational product
    7. language of the informed consent
  16. Introduced a real clinical trial documents and given full access to all documents and staff:
    1. define roles and responsibilities of the inspection team
    2. prepare an inspection plan
    3. conduct an opening meeting
    4. interview critical staff
    5. conduct full inspection
    6. report on findings
    7. present findings to the real client

With the two additional weeks (one week for pre-course activities in the beginning, and one week for evaluation at the end), the full course will take 24 weeks.