ACRP CP FINAL - EXAMINATION
COMPLETE QUESTIONS AND DETAILED SOLUTIONS
LATEST UPDATE THIS YEAR JUST RELEASED
Question 1: 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
Question 2: According to ICH GCP what should Sponsors provide
to investigators and/or the investigators designated
representatives concerning making corrections on CRFs?
Answer:
Guidance
Question 3: What does ICH GCP say the investigator should do in
the event of premature unblinding?
Answer:
promptly document and explain to the sponsor
Question 4: According to ICH GCP where would you file the Signed
Informed Consent Forms?
Answer:
The investigator file only
,Question 5: During the clinical conduct of the trial where should
signed informed consent forms be filed?
Answer:
The investigator file only
Question 6: 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.
Question 7: 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
Question 8: 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
Question 9: 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
Question 10: 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timing of the data to be collected for withdrawn subjects C) Whether and how
subjects are to be replaced D) The follow-up for subjects withdrawn from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
Question 11: 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
Question 12: 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.
, Question 13: According to ICH GCP The investigator should submit
written summaries of the trial status to the IRB/IEC:
Answer:
Annually, or more frequently, if requested by the IRB/IEC
Question 14: According to ICH GCP when should the sponsor
update the Investigators Brochure?
Answer:
As significant new information becomes available
Question 15: According to ICH GCP an IRB/IEC should safeguard
the:
Answer:
Rights, safety and well-being of all trial subjects
Question 16: 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
Question 17: 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
COMPLETE QUESTIONS AND DETAILED SOLUTIONS
LATEST UPDATE THIS YEAR JUST RELEASED
Question 1: 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
Question 2: According to ICH GCP what should Sponsors provide
to investigators and/or the investigators designated
representatives concerning making corrections on CRFs?
Answer:
Guidance
Question 3: What does ICH GCP say the investigator should do in
the event of premature unblinding?
Answer:
promptly document and explain to the sponsor
Question 4: According to ICH GCP where would you file the Signed
Informed Consent Forms?
Answer:
The investigator file only
,Question 5: During the clinical conduct of the trial where should
signed informed consent forms be filed?
Answer:
The investigator file only
Question 6: 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.
Question 7: 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
Question 8: 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
Question 9: 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
Question 10: 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
Question 11: 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
Question 12: 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.
, Question 13: According to ICH GCP The investigator should submit
written summaries of the trial status to the IRB/IEC:
Answer:
Annually, or more frequently, if requested by the IRB/IEC
Question 14: According to ICH GCP when should the sponsor
update the Investigators Brochure?
Answer:
As significant new information becomes available
Question 15: According to ICH GCP an IRB/IEC should safeguard
the:
Answer:
Rights, safety and well-being of all trial subjects
Question 16: 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
Question 17: 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
