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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 Multicentre Trials

Question Number 1:

What should be facilitated in Multicentre Trials according to ICH GCP?

A
Consistency between sites
B
Communication between investigators
C
Regular review of common audit findings
D
Audits of randomly selected sites

Question Number 2:

ICH GCP states that in Multicentre Trials all investigators are given instructions on which of the following:

1. following the protocol

2. complying with a uniform set of standards for the assessment of clinical and laboratory findings

3. completing the CRFs

A
None of them
B
1 and 2 only
C
2 and 3 only
D
1, 2 and 3

Question Number 3:

According to ICH GCP the sponsor should ensure that for mulitcentre trials the responsibilities of who are documented prior to the start of the trial?

A
coordinating investigator(s)
B
coordinating investigator(s) and the other participating investigator(s)
C
all participating investigators
D
all principal investigators

Question Number 4:

According to the Multicentre Trials section of ICH GCP when should supplemental CRFs be provided?

A
For investigators who are collecting additional data
B
For country/region specific requirements
C
To collect screening data to ensure consistency across all trial sites
D
To allow for additional recruitment at specific sites

Question Number 5:

According to the Multicentre Trials section of ICH GCP what should all investigators do?

1. conduct the trial in strict compliance with the protocol agreed to by the sponsor

2. conduct the trial in strict compliance with the protocol agreed to by the regulatory authority(ies) if required

3. conduct the trial in strict compliance with the protocol given apporval/favourable opinion by the IRB/IEC

A
1 only
B
2 only
C
1 and 3 only
D
1, 2 and 3

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