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 ...
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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