GOOD CLINICAL PRACTICE 2026 TEST PAPER QUESTIONS
AND ANSWERS GRADED A+
✔✔_____________________ is an individual, or judicial or other body, authorized
under applicable law to consent on behalf of a prospective subject to the subject's
participation in the procedure(s) involved in the research. - ✔✔Legally Authorized
Representative (LAR)
✔✔T/F
the U.S. compliance with ICH E6 is voluntary, but as with any published FDA guidance,
compliance is considered part of GCP. - ✔✔T
✔✔ICH has developed over _______________ guidelines on Quality, Safety, Efficacy
and Multidisciplinary topics, in addition to products including Electronic Standards for
the Transfer of Regulatory Information (ESTRI), the Common Technical Document
(CTD & eCTD), and the Medical Dictionary for Regulatory Activities (MedDRA). -
✔✔sixty (60)
✔✔The ICH E6 topic falls under the__________category in the ICH guidelines and
pertains specifically to the conduct of clinical research to support marketing applications
for drugs. It is one of over two hundred (200) guidance documents issued in this
process. ICH E6 provides a unified standard for designing, conducting, recording, and
reporting research involving human subjects. - ✔✔"Efficacy"
✔✔The two (2) important goals of ICH E6 are to assure that: - ✔✔The rights, well-being,
and confidentiality of trial subjects are protected and Trial data are credible
✔✔T/F
ICH E6 is not codified in U.S. federal regulation and does not carry the same legally
binding weight of the code of federal regulations. - ✔✔T
✔✔A primary purpose of the ICH is to:
A) Require publication of negative trial results.
B) Develop mandatory worldwide regulations for drug development.
C) Require FDA registration of worldwide clinical trials.
D) Minimize the need for redundant research. - ✔✔D
✔✔The ICH GCP guidelines:
A) Require certification of clinical research sites and investigators
B) Guarantee that a submission in any ICH region will be approved for marketing.
C) Replace FDA regulations for internationally conducted studies of drugs that will be
marketed in the U.S.
D) Set standards for the design, conduct, monitoring and reporting of clinical research. -
✔✔D
, ✔✔ICH E6 describes standards that apply to:
A) Research sponsors
B) only Investigators
C) only Investigators, sponsors, and IRBs
D) IRBs only - ✔✔C
✔✔In the United States, following the ICH E6 guideline is:
A) Mandatory for studies conducted outside the United States.
B) Mandatory for drug studies.
C) Mandatory for investigational device studies.
D) Voluntary for FDA-regulated drug studies. - ✔✔D
✔✔Regarding subject receipt of a signed and dated copy of the consent forms, which is
true about FDA regulations?
A) The FDA regulations allow subjects or the legally acceptable representatives (LARs)
to receive either a signed or unsigned copy.
B)The FDA regulations do not specify if the subject or the legally acceptable
representative (LAR) must receive a signed and dated copy of the consent forms
C) The FDA regulations require that the subject or the legally acceptable representative
(LAR) receive a copy of the signed and dated written informed consent form
D)The FDA regulations require a witness to document that the subject or the legally
acceptable representative (LAR) received the signed and dated copy of the consent
forms. - ✔✔A
✔✔The new ICH E6(R2) integrated addendum requires sponsors to implement systems
to manage quality throughout all stages of the trial process. The system should use a
risk-based approach including which of the following?
A) Use of the PDA cycle (Plan, Do, Act) during the annual continuing review.
B) Mandatory use of ICH E6 template Case Report Forms for all drug studies to be
submitted to regulatory authorities
C) Identification of study risks to determine which may safely be omitted from continual
monitoring
D)Complete on-site documentation audits every 3-6 months. - ✔✔C
✔✔ICH E6 has broader requirements than FDA or HHS concerning confidentiality of
medical records and access by third parties. If investigators are complying with ICH E6
guideline, they must:
A) Clearly disclose to subjects in the informed consent form that the monitor, auditor,
IRB/IEC, and the regulatory authorities may have access to the subject's medical
records
B) Obtain a non-disclosure form before notifying the subject's primary physician
C) Include a statement in the consent form that confidentiality of trial data cannot be
guaranteed because of foreign involvement and the possibility of hacking
AND ANSWERS GRADED A+
✔✔_____________________ is an individual, or judicial or other body, authorized
under applicable law to consent on behalf of a prospective subject to the subject's
participation in the procedure(s) involved in the research. - ✔✔Legally Authorized
Representative (LAR)
✔✔T/F
the U.S. compliance with ICH E6 is voluntary, but as with any published FDA guidance,
compliance is considered part of GCP. - ✔✔T
✔✔ICH has developed over _______________ guidelines on Quality, Safety, Efficacy
and Multidisciplinary topics, in addition to products including Electronic Standards for
the Transfer of Regulatory Information (ESTRI), the Common Technical Document
(CTD & eCTD), and the Medical Dictionary for Regulatory Activities (MedDRA). -
✔✔sixty (60)
✔✔The ICH E6 topic falls under the__________category in the ICH guidelines and
pertains specifically to the conduct of clinical research to support marketing applications
for drugs. It is one of over two hundred (200) guidance documents issued in this
process. ICH E6 provides a unified standard for designing, conducting, recording, and
reporting research involving human subjects. - ✔✔"Efficacy"
✔✔The two (2) important goals of ICH E6 are to assure that: - ✔✔The rights, well-being,
and confidentiality of trial subjects are protected and Trial data are credible
✔✔T/F
ICH E6 is not codified in U.S. federal regulation and does not carry the same legally
binding weight of the code of federal regulations. - ✔✔T
✔✔A primary purpose of the ICH is to:
A) Require publication of negative trial results.
B) Develop mandatory worldwide regulations for drug development.
C) Require FDA registration of worldwide clinical trials.
D) Minimize the need for redundant research. - ✔✔D
✔✔The ICH GCP guidelines:
A) Require certification of clinical research sites and investigators
B) Guarantee that a submission in any ICH region will be approved for marketing.
C) Replace FDA regulations for internationally conducted studies of drugs that will be
marketed in the U.S.
D) Set standards for the design, conduct, monitoring and reporting of clinical research. -
✔✔D
, ✔✔ICH E6 describes standards that apply to:
A) Research sponsors
B) only Investigators
C) only Investigators, sponsors, and IRBs
D) IRBs only - ✔✔C
✔✔In the United States, following the ICH E6 guideline is:
A) Mandatory for studies conducted outside the United States.
B) Mandatory for drug studies.
C) Mandatory for investigational device studies.
D) Voluntary for FDA-regulated drug studies. - ✔✔D
✔✔Regarding subject receipt of a signed and dated copy of the consent forms, which is
true about FDA regulations?
A) The FDA regulations allow subjects or the legally acceptable representatives (LARs)
to receive either a signed or unsigned copy.
B)The FDA regulations do not specify if the subject or the legally acceptable
representative (LAR) must receive a signed and dated copy of the consent forms
C) The FDA regulations require that the subject or the legally acceptable representative
(LAR) receive a copy of the signed and dated written informed consent form
D)The FDA regulations require a witness to document that the subject or the legally
acceptable representative (LAR) received the signed and dated copy of the consent
forms. - ✔✔A
✔✔The new ICH E6(R2) integrated addendum requires sponsors to implement systems
to manage quality throughout all stages of the trial process. The system should use a
risk-based approach including which of the following?
A) Use of the PDA cycle (Plan, Do, Act) during the annual continuing review.
B) Mandatory use of ICH E6 template Case Report Forms for all drug studies to be
submitted to regulatory authorities
C) Identification of study risks to determine which may safely be omitted from continual
monitoring
D)Complete on-site documentation audits every 3-6 months. - ✔✔C
✔✔ICH E6 has broader requirements than FDA or HHS concerning confidentiality of
medical records and access by third parties. If investigators are complying with ICH E6
guideline, they must:
A) Clearly disclose to subjects in the informed consent form that the monitor, auditor,
IRB/IEC, and the regulatory authorities may have access to the subject's medical
records
B) Obtain a non-disclosure form before notifying the subject's primary physician
C) Include a statement in the consent form that confidentiality of trial data cannot be
guaranteed because of foreign involvement and the possibility of hacking
