Of the following, which is NOT a GCP principle? (Please check all that are
relevant.)
Benefits must be evaluated against any predictable hazards and inconveniences.
Data must be captured, processed, and kept in a way that guarantees participant
confidentiality and permits correct reporting, interpretation, and verification.
If the study's findings did not meet expectations, results do not need to be
published.
A publication policy, monitoring information, and inclusion and exclusion
criteria must all be included in the study protocol.
The study must be supported by sufficient non-clinical and clinical data on the
investigational medication being used.
The Nuremberg Code of 1947 must be followed when conducting the study.
ANSWER If the study's findings did not meet expectations, results do not need
to be published.
The 1947 Nuremberg Code must be followed when conducting the study.
Legally, research that do not adhere to ICH-GCP criteria will be di
scontinued.
Indeed
, False—False ANSWER
Adopting appropriate clinical practice guidelines is crucial for researchers in
low- and middle-income countries since their work will have consequences.
Indeed
False—True
Regarding the informed consent procedure, which of the following is NOT true?
(Please check all that are relevant.)
All documentation and materials pertaining to participants must have IEC/IRB
approval.
Participants must be informed of any alternate options or treatments after
providing their consent.
Consent must be freely provided and free from undue influence or compulsion.
Anytime during the study, a volunteer may leave without giving a reason.
As long as the subject has consented to participate in the study, the consent
form can be stamped or signed at any point throughout participation even if the
individual is illiterate. - ANSWER As long as the subject has consented to
participate in the study, the consent form can be stamped or signed at any point
throughout participation even if the individual is illiterate.
relevant.)
Benefits must be evaluated against any predictable hazards and inconveniences.
Data must be captured, processed, and kept in a way that guarantees participant
confidentiality and permits correct reporting, interpretation, and verification.
If the study's findings did not meet expectations, results do not need to be
published.
A publication policy, monitoring information, and inclusion and exclusion
criteria must all be included in the study protocol.
The study must be supported by sufficient non-clinical and clinical data on the
investigational medication being used.
The Nuremberg Code of 1947 must be followed when conducting the study.
ANSWER If the study's findings did not meet expectations, results do not need
to be published.
The 1947 Nuremberg Code must be followed when conducting the study.
Legally, research that do not adhere to ICH-GCP criteria will be di
scontinued.
Indeed
, False—False ANSWER
Adopting appropriate clinical practice guidelines is crucial for researchers in
low- and middle-income countries since their work will have consequences.
Indeed
False—True
Regarding the informed consent procedure, which of the following is NOT true?
(Please check all that are relevant.)
All documentation and materials pertaining to participants must have IEC/IRB
approval.
Participants must be informed of any alternate options or treatments after
providing their consent.
Consent must be freely provided and free from undue influence or compulsion.
Anytime during the study, a volunteer may leave without giving a reason.
As long as the subject has consented to participate in the study, the consent
form can be stamped or signed at any point throughout participation even if the
individual is illiterate. - ANSWER As long as the subject has consented to
participate in the study, the consent form can be stamped or signed at any point
throughout participation even if the individual is illiterate.
