GOOD CLINICAL PRACTICE MAIN EXAMINATION SET
QUESTIONS AND ANSWERS GRADED A+
✔✔Which of the following is an important component of drug accountability? - ✔✔• Drug
shipping and disposition records
* Drug accountability includes tracking of the receipt and return/destruction of the
investigational product and dispensing/administration records showing subject usage of
the product. Although environmental controls should also be documented, they are not
considered part of accountability tracking. Compounding procedures and patent
expiration dates are the responsibility of the sponsor.
✔✔Who is ultimately responsible for product accountability at the study site? - ✔✔•
Investigator
* The investigator agrees to this responsibility in signing Form FDA 1572. Investigators
are responsible for every individual unit of product received. The investigator may
delegate some responsibility for product accountability to qualified personnel, such as
the pharmacist or study coordinator, but the investigator retains ultimate responsibility
for product accountability.
✔✔Investigational product dispensing or administration information for the sponsor is
recorded on the: - ✔✔• Case report form
* When a drug is dispensed or administered to a subject, it is necessary to record this
information for the sponsor's use and analysis by completing the case report form. Form
FDA 1572, insurance claim forms, and informed consent forms do not include this
information.
✔✔The packaging of investigational drugs should ideally: - ✔✔• Be designed to help
with subject compliance
* Packaging is an important part of the clinical research process. Many studies use
specifically designed blister packages which can help subject compliance by providing
packages that are easy to use, place one treatment under each dome, and have
specific written instruction on the card so that subjects know exactly when to take their
study drugs.
✔✔The first Investigator's Brochure IB for a proposed clinical trial of a new drug is
based primarily on which of the following? - ✔✔• The IB is generated initially from the
preclinical data. Phase II study data would inform updates to the IB, but not the first
version.
, ✔✔ICH provides guidelines that are divided into the following four topic areas: Quality,
Safety, Efficacy, and Multidisciplinary Topics. - ✔✔• True. ICH has developed guidelines
in four categories: Quality, Safety, Efficacy, and Multidisciplinary topics.
✔✔In the informed consent process, the subject must be informed if they will receive no
clinical benefit from their participation in study. - ✔✔• True. ICH (2016) E6 Section
4.8.10(h) requires an explanation of "the reasonably expected benefits. When there is
no intended clinical benefit to the subject, the subject should be made aware of this."
✔✔Which party submits the completed, signed Form FDA 1572 to the FDA? - ✔✔• The
sponsor submits the FDA Form 1572 to the FDA.
✔✔The ultimate responsibility for the disposition of the investigational product lies with:
- ✔✔• While the investigator can delegate duties to qualified staff, the ultimate
responsibility for the investigational product lies with the investigator.
✔✔An investigator conducting a study of a medical device under an IDE is required to
complete and sign which of the following? - ✔✔• An investigator's agreement
* An investigator's agreement is signed by an investigator conducting a study of a
medical device under an IDE. There is no standard FDA form for investigator
agreements. The other choices are not specified in investigational device regulations.
✔✔A 510(k) Premarket Notification is submitted: - ✔✔• When the new device to be
marketed is substantially similar (equivalent) to one already on the market.
* A 510(k) Premarket Notification is submitted when a manufacturer wishes to market a
qualified medical device in the U.S. without conducting clinical trials. To do so, the
manufacturer must demonstrate to FDA that the device is equivalent to one already
marketed. An IDE must be submitted when clinical trials of investigational devices are
needed to determine the safety and effectiveness of a new device or when studying
substantial modifications to or new intended uses for devices already on the market. A
Premarket Approval (PMA) might be submitted for the FDA to evaluate the results of a
completed clinical trial of a Class III device.
✔✔Evaluation of Unanticipated Adverse Device Effects (UADEs) must be reported to
the FDA by the: - ✔✔• Sponsor
* The investigator reports UADEs to the sponsor and the local IRB. The sponsor
transmits evaluations of these reports to the FDA.
✔✔Consider a study conducted a regional hospital where the investigator is one of the
on staff physicians. The study focuses on smoking habits among the hospital's nurses
and its relationship to lung cancer.
QUESTIONS AND ANSWERS GRADED A+
✔✔Which of the following is an important component of drug accountability? - ✔✔• Drug
shipping and disposition records
* Drug accountability includes tracking of the receipt and return/destruction of the
investigational product and dispensing/administration records showing subject usage of
the product. Although environmental controls should also be documented, they are not
considered part of accountability tracking. Compounding procedures and patent
expiration dates are the responsibility of the sponsor.
✔✔Who is ultimately responsible for product accountability at the study site? - ✔✔•
Investigator
* The investigator agrees to this responsibility in signing Form FDA 1572. Investigators
are responsible for every individual unit of product received. The investigator may
delegate some responsibility for product accountability to qualified personnel, such as
the pharmacist or study coordinator, but the investigator retains ultimate responsibility
for product accountability.
✔✔Investigational product dispensing or administration information for the sponsor is
recorded on the: - ✔✔• Case report form
* When a drug is dispensed or administered to a subject, it is necessary to record this
information for the sponsor's use and analysis by completing the case report form. Form
FDA 1572, insurance claim forms, and informed consent forms do not include this
information.
✔✔The packaging of investigational drugs should ideally: - ✔✔• Be designed to help
with subject compliance
* Packaging is an important part of the clinical research process. Many studies use
specifically designed blister packages which can help subject compliance by providing
packages that are easy to use, place one treatment under each dome, and have
specific written instruction on the card so that subjects know exactly when to take their
study drugs.
✔✔The first Investigator's Brochure IB for a proposed clinical trial of a new drug is
based primarily on which of the following? - ✔✔• The IB is generated initially from the
preclinical data. Phase II study data would inform updates to the IB, but not the first
version.
, ✔✔ICH provides guidelines that are divided into the following four topic areas: Quality,
Safety, Efficacy, and Multidisciplinary Topics. - ✔✔• True. ICH has developed guidelines
in four categories: Quality, Safety, Efficacy, and Multidisciplinary topics.
✔✔In the informed consent process, the subject must be informed if they will receive no
clinical benefit from their participation in study. - ✔✔• True. ICH (2016) E6 Section
4.8.10(h) requires an explanation of "the reasonably expected benefits. When there is
no intended clinical benefit to the subject, the subject should be made aware of this."
✔✔Which party submits the completed, signed Form FDA 1572 to the FDA? - ✔✔• The
sponsor submits the FDA Form 1572 to the FDA.
✔✔The ultimate responsibility for the disposition of the investigational product lies with:
- ✔✔• While the investigator can delegate duties to qualified staff, the ultimate
responsibility for the investigational product lies with the investigator.
✔✔An investigator conducting a study of a medical device under an IDE is required to
complete and sign which of the following? - ✔✔• An investigator's agreement
* An investigator's agreement is signed by an investigator conducting a study of a
medical device under an IDE. There is no standard FDA form for investigator
agreements. The other choices are not specified in investigational device regulations.
✔✔A 510(k) Premarket Notification is submitted: - ✔✔• When the new device to be
marketed is substantially similar (equivalent) to one already on the market.
* A 510(k) Premarket Notification is submitted when a manufacturer wishes to market a
qualified medical device in the U.S. without conducting clinical trials. To do so, the
manufacturer must demonstrate to FDA that the device is equivalent to one already
marketed. An IDE must be submitted when clinical trials of investigational devices are
needed to determine the safety and effectiveness of a new device or when studying
substantial modifications to or new intended uses for devices already on the market. A
Premarket Approval (PMA) might be submitted for the FDA to evaluate the results of a
completed clinical trial of a Class III device.
✔✔Evaluation of Unanticipated Adverse Device Effects (UADEs) must be reported to
the FDA by the: - ✔✔• Sponsor
* The investigator reports UADEs to the sponsor and the local IRB. The sponsor
transmits evaluations of these reports to the FDA.
✔✔Consider a study conducted a regional hospital where the investigator is one of the
on staff physicians. The study focuses on smoking habits among the hospital's nurses
and its relationship to lung cancer.
