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Good Clinical Practice (GCP) NIDA Clinical Trials Network (1).
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Good Clinical Practice (GCP) NIDA Clinical Trials Network (1).
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Good Clinical Practice (GCP) NIDAClinical Trials Network
As the research coordinator for a study at ABC Treatment Center, you discussed the
informed consent process with the participant and she signed and dated the
informed consent form. After re-reviewing the form later that day, you noticed that the
study participant signed the informed consent form but added yesterday's date and
she has already left the clinic. What should you do? - CORRECT ANSWER-On the
next visit, ask the participant to cross out the wrong date, add the correct date, then
initial, and date the informed consent form with the current date.
Now that you know how to correct the informed consent form when an error occurs,
how could you prevent the problem from occurring again? - CORRECT
ANSWER-Have a list handy of key items to check when reviewing informed consent
documents signed by study participants.
Highlight the initial, signature, and date lines in the actual consent form document so
that as the form is discussed, these areas are clearly identified.
Be sure to review the signed informed consent form before the participant leaves the
visit to ensure that all items are marked, signed, and dated appropriately.
Keep a calendar handy to check today's date against the date provided by the
participant in the form.
A person who has a court-appointed legal guardian or who has been determined by
a court to be legally incompetent can sign an informed consent form. - CORRECT
ANSWER-False
If the research participant is a minor (under the age of 18), which of the following
must occur before the individual can participate in the research study? - CORRECT
ANSWER-The parent/legal guardian must give permission for the minor to
participate AND minor must agree to participate in the research.
Which of the following applies when new information is available to researchers
regarding the study medication? - CORRECT ANSWER-Study participants will be
advised promptly if the researchers find any new information that might affect them.
Participants do not have to continue taking part in the study. Participants will not
incur penalties or loss of benefits if they withdraw from the study.
Because of being incarcerated, prisoners may not be able to make a voluntary
decision about participating in a clinical trial. - CORRECT ANSWER-True
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