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Weekly GCP Challenge

Answer the questions below and then click the button. The next page will mark your answers and show you how well you have done compared with the previous people who have taken the tests.


Challenge: ICH GCP - Records and Reports

Question Number 1:

What completes this statement in ICH GCP section 4.9 Records and Reports?

"The investigator should ensure the accuracy, completeness, legibility and XXXXX of the data reported to the sponsor in the CRFs and in all required reports"?
A
 transmission
B
 transcription
C
 verification
D
 timeliness

Question Number 2:

What is needed to complete the following statement in ICH GCP Section 4.9?

"Data reported on the CRF, that are derived from source documents should be consistent with the source documents or ........"
A
 the source documents should be updated
B
 a filenote be generated
C
 the discrepancies should be explained
D
 a data query should be raised

Question Number 3:

What is needed to complete the following statement from ICH GCP Section 4.9?

"Upon request of the monitor, auditor, IRB/IEC, or regulatory authority, the investigator/institution should make available XXXXXXXXXX all requested trial related records"

 
A
 following a written request
B
 subject to an appropriate contract being in place
C
 for direct access
D
 immediately

Question Number 4:

What completes the following statement form ICH GCP Section 4.9 regarding Essential Documents?

"The investigator/institution should take measures to prevent XXXXXXX destruction of these documents"
A
 Incorrect
B
 accidental or premature
C
 inappropriate
D
 unauthorised

Question Number 5:

What completes the following statement from ICH GCP Section 4.9?

"Any change or correction to a CRF should be dated, initialed, and explained (if necessary) and should XXXXXXXXX"
A
 not obscure the original entry
B
 be signed by the investigator
C
 be verifiable in the source notes
D
 be recorded in a change log

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