Question

Which of the following would NOT be a good example of a protocol violation?

A. The Research Coordinator has consistently arrived late to study visits.

B. Only participants over 30 years old have been given the study remuneration described in the protocol.

C. Two participants were enrolled in the study although they do not meet the inclusion criteria.

D. A CBC blood specimen is collected before the participant has signed an Informed Consent form.​

Answer 1

The answer is B option

Only participants over 30 years old have been given the study remuneration described in the protocol.

A. The research coordinator regularly arrives after the scheduled time for study visits.

• It is against procedure because the researchers' work will not be productive if the study coordinator continually arrives late.

C. Despite not meeting the inclusion criteria, two participants were included in the study.

• There is no utility for it and a clear violation of procedure if two participants fail to meet the inclusion criterion.

Before the individual has signed an informed consent form.

D. A CBC blood sample is taken.

• A CBC blood sample obtained following the participant's signature on an informed consent form
• Therefore, it also breaks procedure.

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