1|Page
ACRP CP FINAL EXAM NEWEST ACTUAL EXAM
COMPLETE 150 QUESTIONS AND CORRECT
DETAILED ANSWERS WITH RATIONALES (VERIFIED
ANSWERS) |ALREADY GRADED A+||BRAND NEW
EXAM!!!
According to ICH GCP the sponsor should take steps to
ensure that the investigational product(s) are stable over
what? - ANSWER-The period of use
According to ICH GCP what should Sponsors provide to
investigators and/or the investigators designated
representatives concerning making corrections on CRFs?
- ANSWER-Guidance
What does ICH GCP say the investigator should do in the
event of premature unblinding? - ANSWER-promptly
document and explain to the sponsor
According to ICH GCP where would you file the Signed
Informed Consent Forms? - ANSWER-The investigator file
only
During the clinical conduct of the trial where should signed
informed consent forms be filed? - ANSWER-The
investigator file only
,2|Page
According to section 5 of ICH GCP, Sponsor, when should
the monitor submit a written report to the sponsor? -
ANSWER-after each trial-site visit or after each trial-
related communication.
According to ICH GCP which of the following lists are
required for clinical trials to be compliant with ICH GCP: 1.
A list of appropriately qualified persons to whom the
investigator has delegated significant trial-related duties 2.
A list of IRB/IEC members and their qualifications 3. A list
of the individuals who are authorized to make data
changes - ANSWER-All of them
The IRB/IEC should ensure that information regarding
payment to subjects, including the _____________ to trial
subjects, is set forth in the written informed consent form
and any other written information to be provided to
subjects. The way payment will be prorated should be
specified. - ANSWER-Method, amount, schedule of
payments
What words are missing from the following statement in
ICH GCP: For _______________ the investigator should
supply the sponsor and the IRB/IEC with any additional
requested information? - ANSWER-reported deaths
,3|Page
According to section 6 of ICH GCP what are the
procedures generally included in protocols regarding
Subject Withdrawal Criteria? - ANSWER-A) When and
how to withdraw subjects from the trial/IP treatment B) The
type and timing of the data to be collected for withdrawn
subjects C) Whether and how subjects are to be replaced
D) The follow-up for subjects withdrawn from
investigational product treatment/trial treatment
According to ICH GCP which of the following documents
should be reviewed by the IEC/IRB? 1. The Investigator's
Brochure 2. The Investigator's CV 3. The subject
compensation 4. Payment to the Investigator - ANSWER-
1, 2, and 3 only
What is the IRB/IEC composition recommendation in ICH
GCP? - ANSWER-(a) At least five members.
(b) At least one member whose primary area of interest is
in a nonscientific area.
(c) At least one member who is independent of the
institution/trial site.
According to ICH GCP The investigator should submit
written summaries of the trial status to the IRB/IEC: -
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ANSWER-Annually, or more frequently, if requested by the
IRB/IEC
According to ICH GCP when should the sponsor update
the Investigators Brochure? - ANSWER-As significant new
information becomes available
According to ICH GCP an IRB/IEC should safeguard the: -
ANSWER-Rights, safety and well-being of all trial subjects
In ICH GCP what is the difference in requirements
between a non-therapeutic and a therapeutic clinical trial?
- ANSWER-Oral and proxy consent is not normally
allowable for non-therapeutic trial
According to ICH GCP section 5.2 Contract Research
Organization, Any trial-related duty and function that is
transferred to and assumed by a CRO should be specified
in: - ANSWER-Writing
Documents which individually and collectively permit
evaluation of the conduct of a study and the quality of the
data produced" is the definition of: - ANSWER-Essential
documents
ACRP CP FINAL EXAM NEWEST ACTUAL EXAM
COMPLETE 150 QUESTIONS AND CORRECT
DETAILED ANSWERS WITH RATIONALES (VERIFIED
ANSWERS) |ALREADY GRADED A+||BRAND NEW
EXAM!!!
According to ICH GCP the sponsor should take steps to
ensure that the investigational product(s) are stable over
what? - ANSWER-The period of use
According to ICH GCP what should Sponsors provide to
investigators and/or the investigators designated
representatives concerning making corrections on CRFs?
- ANSWER-Guidance
What does ICH GCP say the investigator should do in the
event of premature unblinding? - ANSWER-promptly
document and explain to the sponsor
According to ICH GCP where would you file the Signed
Informed Consent Forms? - ANSWER-The investigator file
only
During the clinical conduct of the trial where should signed
informed consent forms be filed? - ANSWER-The
investigator file only
,2|Page
According to section 5 of ICH GCP, Sponsor, when should
the monitor submit a written report to the sponsor? -
ANSWER-after each trial-site visit or after each trial-
related communication.
According to ICH GCP which of the following lists are
required for clinical trials to be compliant with ICH GCP: 1.
A list of appropriately qualified persons to whom the
investigator has delegated significant trial-related duties 2.
A list of IRB/IEC members and their qualifications 3. A list
of the individuals who are authorized to make data
changes - ANSWER-All of them
The IRB/IEC should ensure that information regarding
payment to subjects, including the _____________ to trial
subjects, is set forth in the written informed consent form
and any other written information to be provided to
subjects. The way payment will be prorated should be
specified. - ANSWER-Method, amount, schedule of
payments
What words are missing from the following statement in
ICH GCP: For _______________ the investigator should
supply the sponsor and the IRB/IEC with any additional
requested information? - ANSWER-reported deaths
,3|Page
According to section 6 of ICH GCP what are the
procedures generally included in protocols regarding
Subject Withdrawal Criteria? - ANSWER-A) When and
how to withdraw subjects from the trial/IP treatment B) The
type and timing of the data to be collected for withdrawn
subjects C) Whether and how subjects are to be replaced
D) The follow-up for subjects withdrawn from
investigational product treatment/trial treatment
According to ICH GCP which of the following documents
should be reviewed by the IEC/IRB? 1. The Investigator's
Brochure 2. The Investigator's CV 3. The subject
compensation 4. Payment to the Investigator - ANSWER-
1, 2, and 3 only
What is the IRB/IEC composition recommendation in ICH
GCP? - ANSWER-(a) At least five members.
(b) At least one member whose primary area of interest is
in a nonscientific area.
(c) At least one member who is independent of the
institution/trial site.
According to ICH GCP The investigator should submit
written summaries of the trial status to the IRB/IEC: -
, 4|Page
ANSWER-Annually, or more frequently, if requested by the
IRB/IEC
According to ICH GCP when should the sponsor update
the Investigators Brochure? - ANSWER-As significant new
information becomes available
According to ICH GCP an IRB/IEC should safeguard the: -
ANSWER-Rights, safety and well-being of all trial subjects
In ICH GCP what is the difference in requirements
between a non-therapeutic and a therapeutic clinical trial?
- ANSWER-Oral and proxy consent is not normally
allowable for non-therapeutic trial
According to ICH GCP section 5.2 Contract Research
Organization, Any trial-related duty and function that is
transferred to and assumed by a CRO should be specified
in: - ANSWER-Writing
Documents which individually and collectively permit
evaluation of the conduct of a study and the quality of the
data produced" is the definition of: - ANSWER-Essential
documents
