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CRA interview exam questions & answers 2024/2025
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CRA interview exam questions & answers 2024/2025 ICH GCP Guidelines - ANSWERSSet standards for the design, conduct, monitoring and reporting of clinical research. ICH - International Council for Harmonization GCP - Good Clinical Practice This is important because it ensures the quality of ...

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  • September 18, 2024
  • 5
  • 2024/2025
  • Exam (elaborations)
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  • cra interview exam questions answers

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CRA interview exam questions &
answers 2024/2025

ICH GCP Guidelines - ANSWERSSet standards for the design, conduct, monitoring and reporting of clinical
research.

ICH - International Council for Harmonization

GCP - Good Clinical Practice

This is important because it ensures the quality of the information collected



What is an SAE and how is it reported? Name 3 SAE's - ANSWERSSerious Adverse Event that is 1. life
threatening 2. results in death 3. Prolonged hospitalization 4. Disability 5. Congenital abnormality



Adverse Event (AE) - ANSWERSAny untoward medical occurrence in a patient or clinical investigation
subject administered a pharmaceutical product and which does not necessarily have a causal
relationship with this treatment. (ICH GCP E6 1.2)



Components to a monitoring visit - ANSWERSICF review, inclusion exclusion criteria review, Source data
verification, quires and action items, walk through of the facility, IP accountability



Why IQVIA - ANSWERS



How to increase PI contact - ANSWERS- Set up meetings via zoom, microsoft teams

- Approach a sub-investigators

- Provide them with the direct phone number



What would happen if you got on site and they said they don't print out certified copies of the EMR and
you don't have an EMR account - ANSWERSTypically this needs to be requested in advance so I can look
over the shoulder of the coordinator as they navigate me through the EMR

Ask for read only access

, What happens when you get on site and a SAE what never reported. - ANSWERS- That is a major
protocol deviation because it is effecting patient safety

- Make sure that while you are there the PI or sub-I needs to submit that and include the subject
number, the causality and date



What is IP accountability - ANSWERSInventory records document that IP was used only: • in the clinical
trial. • for study participants. • in accordance with the approved protocol.

Each IP kit number needs to match the IP number listed according to what was given to the patient
which is verified with the IWRS system



IP - ANSWERSInvestigational Product



IWRS/IVRS - ANSWERSInteractive Web Response System

Interactive Voice Response Systems



are the technologies that research sites use to enroll patients into clinical trials, randomize patients, and
manage study drug supplies



EDC - ANSWERSElectronic Data Capture

software that stores patient data collected in clinical trials

Is is saved electronically on a case report form (eCRF)

Medidata (Rave)



ICH Guidelines - ANSWERSQuality

Safety

Efficacy

Multidisciplinary



IRB (Institutional Review Board) - ANSWERSany research needs to be proposed to their IRB, or IRB of
record, to review for ethical violations and/or procedural errors

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