CTM Final Exam – Study Guide, Practice Questions & Comprehensive
Review
T/F: An advertisement for a clinical trial may state that the study drug will be offered free of
charge - ANS ✔✔False
T/F: All studies are required to have an investigator meeting - ANS ✔✔False
T/F: Discussing safety reporting requirements is an important aspect of a site initiation visit for a
clinical trial - ANS ✔✔True
T/F: A media advertisement for a clinical trial may state that the study drug is safe and effective,
but only if it's made clear that the drug is not approved - ANS ✔✔False
T/F: HIPPA privacy laws do not apply to clinical trial recruitment - ANS ✔✔False
T/F: A clinical trial site is typically requested to report SAEs to the sponsor within 24-48 hours of
discovering the event - ANS ✔✔True
T/F: A double dummy design can be used to compare 2 different dosage forms in a clinical trial -
ANS ✔✔True
T/F: In Canada, clinical trial sites are required to retain study records for 25 years after a study is
closed - ANS ✔✔True
T/F: Sponsors are not permitted to advertise or recruit for clinical trials on social media - ANS
✔✔False
, T/F: All regulatory documentation should be collected from a clinical trial site prior to shipping
the study drug to the site - ANS ✔✔True
T/F: Group informed consent is advantageous because you can consent a large number of
healthy volunteers or patients at one time - ANS ✔✔True
T/F: Potential study participants must always sign an informed consent document with no
exceptions - ANS ✔✔False.
T/F: In clinical trials, the Delegation of Authority Form allows an investigator to transfer his or
her responsibilities for certain aspects of the trial to another staff member - ANS ✔✔False.
An investigator cannot transfer responsibility--investigator is ultimately responsible
T/F: Due to Good Manufacturing Practice requirements, it is not permitted to re-package a
commercial product for purposes of using it as a comparator in a clinical trial - ANS ✔✔False
T/F: In a clinical trial, the expiration date for an investigational product must always be printed
on the label or container without exception - ANS ✔✔False
T/F: Conducting the informed consent process in a group process is never permitted due to
some local laws - ANS ✔✔False
T/F: In the context of a clinical trial, a patient's medical record would be considered a source
document - ANS ✔✔True
T/F: Potential research subjects are not permitted to ask questions about the clinical trial during
the informed consent process because the informed consent document must speak for itself -
ANS ✔✔False
Review
T/F: An advertisement for a clinical trial may state that the study drug will be offered free of
charge - ANS ✔✔False
T/F: All studies are required to have an investigator meeting - ANS ✔✔False
T/F: Discussing safety reporting requirements is an important aspect of a site initiation visit for a
clinical trial - ANS ✔✔True
T/F: A media advertisement for a clinical trial may state that the study drug is safe and effective,
but only if it's made clear that the drug is not approved - ANS ✔✔False
T/F: HIPPA privacy laws do not apply to clinical trial recruitment - ANS ✔✔False
T/F: A clinical trial site is typically requested to report SAEs to the sponsor within 24-48 hours of
discovering the event - ANS ✔✔True
T/F: A double dummy design can be used to compare 2 different dosage forms in a clinical trial -
ANS ✔✔True
T/F: In Canada, clinical trial sites are required to retain study records for 25 years after a study is
closed - ANS ✔✔True
T/F: Sponsors are not permitted to advertise or recruit for clinical trials on social media - ANS
✔✔False
, T/F: All regulatory documentation should be collected from a clinical trial site prior to shipping
the study drug to the site - ANS ✔✔True
T/F: Group informed consent is advantageous because you can consent a large number of
healthy volunteers or patients at one time - ANS ✔✔True
T/F: Potential study participants must always sign an informed consent document with no
exceptions - ANS ✔✔False.
T/F: In clinical trials, the Delegation of Authority Form allows an investigator to transfer his or
her responsibilities for certain aspects of the trial to another staff member - ANS ✔✔False.
An investigator cannot transfer responsibility--investigator is ultimately responsible
T/F: Due to Good Manufacturing Practice requirements, it is not permitted to re-package a
commercial product for purposes of using it as a comparator in a clinical trial - ANS ✔✔False
T/F: In a clinical trial, the expiration date for an investigational product must always be printed
on the label or container without exception - ANS ✔✔False
T/F: Conducting the informed consent process in a group process is never permitted due to
some local laws - ANS ✔✔False
T/F: In the context of a clinical trial, a patient's medical record would be considered a source
document - ANS ✔✔True
T/F: Potential research subjects are not permitted to ask questions about the clinical trial during
the informed consent process because the informed consent document must speak for itself -
ANS ✔✔False
