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The Clinical Researcher Knowledge Testing
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.

Test Title:
Essential Documents


Question Number 1:
According to ICH GCP where should the initiation visit report be filed
A
 Sponsor file only
B
 Investigator file only
C
 Both Sponsor and Investigator files
D
 Not specified

Question Number 2:
According to ICH GCP where should the Subject Identification code list be filed
A
 Sponsor file only
B
 Investigator file only
C
 Both Sponsor and Investigator files
D
 Not specified

Question Number 3:
According to ICH GCP where should the Audit certificates be filed
A
 Sponsor file only
B
 Investigator file only
C
 Both Sponsor and Investigator files
D
 Not specified

Question Number 4:
According to ICH GCP where should the Signed protocol be filed
A
 Sponsor file only
B
 Investigator file only
C
 Both Sponsor and Investigator files
D
 Not specified

Question Number 5:
According to ICH GCP what are the absolute minimum requirements for essential documents at site before IMP can be sent to the site.
A
 CV of investigator and Clinical Trial Authorisation (CTA)
B
 Ethics Committee Approval and signed protocol
C
 CTA and Ethics Committee Approval
D
 CTA, Ethics Committee Approval and signed protocol

Question Number 6:
What does TMF stand for?
A
 Trial Management File
B
 Trial Master File
C
 Therapeutic Manufacturing File
D
 Therapeutic Master File

Question Number 7:
In which chapter of ICH GCP are essential documents listed?
A
 5
B
 6
C
 7
D
 8

Question Number 8:
Of what activity is this the ICH definition? A systematic and independent examination of trial related activities and documents to determine whether trial related activities were conducted, and the data were recorded, analyzed and accurately reported.....
A
 Inspection
B
 Monitoring
C
 Audit
D
 Ethics Committee Approval

Question Number 9:
Which of the following is the ICH GCP Glossary Definition of a Monitoring Report?
A
 A written report from the monitor to the sponsor after each site visit and/or other trial-related communication according to the sponsor’s SOPs.
B
 A document detailing the trial related compliance of a trial site compiled by a monitor following each site visit or trial related communication.
C
 A written report of the conduct, compliance and progress of a trial site compiled by a monitor following each site visit.
D
 An approved report from the site monitor of all relevant information relating to adherence to the protocol, GCP and, if applicable, local regulatory requirements after each site visit.

Question Number 10:
Which of the following is the ICH GCP Glossary Definition of a Protocol Amendment?
A
 All changes to a protocol that will impact on the inclusion, dosing, recording or follow-up of trial subjects
B
 Any change(s) to a protocol that will result in change(s) to the inclusion, dosing, recording or follow-up of trial subjects.
C
 Change(s) to a protocol that will result in change(s) to conduct of the trial.
D
 A written description of a change(s) to or formal clarification of a protocol

 

 

 

 

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