ACRP-CP EXAM QUESTIONS AND ANSWER; LATEST
UPDATED VERSION 2025-2026; ALREADY GRADED
A+
According to ICH GCP addendum the sponsor should develop a
systematic, prioritized, ______________ approach to monitoring clinical
trials. - correct answer- Risk-based
According to ICH GCP Adverse events and/or laboratory abnormalities
identified in the protocol as critical evaluations should be reported to
the: - correct answer- sponsor
According to ICH GCP adverse events, concomitant medications and
intercurrent illnesses are reported __________________ on the CRFs. -
correct answer- in accordance with the protocol
According to ICH GCP All serious adverse events (SAEs) should be
reported immediately to the: - correct answer- Sponsor
According to ICH GCP an IRB/IEC should safeguard the: - correct
answer- Rights, safety and well-being of all trial subjects
According to ICH GCP contract is _____________, dated, and signed
agreement between two or more involved parties that sets out any
arrangements on delegation and distribution of tasks and obligations
and, if appropriate, on financial matters. - correct answer- Written
,According to ICH GCP double blind usually refers to the
_________________ being unaware of the treatment assignment(s). -
correct answer- subject(s), investigator(s), monitor, and, in some
cases, data analyst(s)
According to ICH GCP for how long the IRB/IEC should retain all relevant
records? - correct answer- For a period of at least 3-years after
completion of the trial
According to ICH GCP how frequently should staff be trained in GCP? -
correct answer- There is no specific requirement
According to ICH GCP how much source data verification (SDV) should be
done? - correct answer- There is no specification
According to ICH GCP how soon should serious adverse events (SAEs) be
reported by the investigator? - correct answer- immediately to the
sponsor
According to ICH GCP if centralised monitoring is used what else should
be in place? - correct answer- Extensive written guidance,
investigator training and meetings
According to ICH GCP if the answer to a question is Investigator then
what could the question be?1. Who has responsibility for the
,investigational product accountability at the trial site2. Who should be
able to demonstrate a potential for recruiting the required number of
suitable subjects within the agreed recruitment period3. Who is
responsible for the ongoing safety evaluation of the investigational
product - correct answer- 1 or 2 only
According to ICH GCP if the trial is prematurely terminated or suspended
for any reason, the investigator/institution should do which of the
following as well as notifying IRB/IEC and local regulatory authorities:1.
Return all IMP to the sponsor immediately2. Contact all subjects to
ensure immediate return of all IMP3. Promptly inform the trial subject4.
Should assure appropriate therapy and treatment follow-up for the
subjects - correct answer- 3 & 4 only
According to ICH GCP Monitors should be appointed by the sponsor.
These monitors should be appropriately trained, and should have what
else? - correct answer- The scientific and/or clinical knowledge
needed to monitor the trial adequately
According to ICH GCP Non-therapeutic trials may be conducted in
subjects with consent of a legally acceptable representative provided the
following conditions are fulfilled: 1) The negative impact on the subject's
well-being is minimized and low 2) The trial is not prohibited by law 3)
The foreseeable risks to the subjects are low 4) The objectives of the trial
can not be met by means of a trial in subjects who can give informed
consent personally - correct answer- All of them
, According to ICH GCP Payments to a subject should be - correct
answer- prorated and not wholly contingent on completion of the
trial by the subject.
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: - correct answer- Writing
According to ICH GCP Section 5.8 Compensation to Subjects and
Investigators which of the following is not true: A) Sponsor should
provide insurance B) Sponsor should indemnify investigator against
claims arising from negligence C) Sponsor should indemnify investigator
against claims arising from malpractice D) both b and c - correct
answer- D
According to ICH GCP Source data should be attributable, legible,
contemporaneous, original, accurate, and complete. Changes to source
data should be _____________, should not obscure the original entry,
and should be explained if necessary (e.g., via an audit trail). - correct
answer- Traceable
According to ICH GCP The investigator should be thoroughly familiar
with the appropriate use of the investigational product(s), as described
in the: - correct answer- Protocol, investigators brochure, and in the
product information
UPDATED VERSION 2025-2026; ALREADY GRADED
A+
According to ICH GCP addendum the sponsor should develop a
systematic, prioritized, ______________ approach to monitoring clinical
trials. - correct answer- Risk-based
According to ICH GCP Adverse events and/or laboratory abnormalities
identified in the protocol as critical evaluations should be reported to
the: - correct answer- sponsor
According to ICH GCP adverse events, concomitant medications and
intercurrent illnesses are reported __________________ on the CRFs. -
correct answer- in accordance with the protocol
According to ICH GCP All serious adverse events (SAEs) should be
reported immediately to the: - correct answer- Sponsor
According to ICH GCP an IRB/IEC should safeguard the: - correct
answer- Rights, safety and well-being of all trial subjects
According to ICH GCP contract is _____________, dated, and signed
agreement between two or more involved parties that sets out any
arrangements on delegation and distribution of tasks and obligations
and, if appropriate, on financial matters. - correct answer- Written
,According to ICH GCP double blind usually refers to the
_________________ being unaware of the treatment assignment(s). -
correct answer- subject(s), investigator(s), monitor, and, in some
cases, data analyst(s)
According to ICH GCP for how long the IRB/IEC should retain all relevant
records? - correct answer- For a period of at least 3-years after
completion of the trial
According to ICH GCP how frequently should staff be trained in GCP? -
correct answer- There is no specific requirement
According to ICH GCP how much source data verification (SDV) should be
done? - correct answer- There is no specification
According to ICH GCP how soon should serious adverse events (SAEs) be
reported by the investigator? - correct answer- immediately to the
sponsor
According to ICH GCP if centralised monitoring is used what else should
be in place? - correct answer- Extensive written guidance,
investigator training and meetings
According to ICH GCP if the answer to a question is Investigator then
what could the question be?1. Who has responsibility for the
,investigational product accountability at the trial site2. Who should be
able to demonstrate a potential for recruiting the required number of
suitable subjects within the agreed recruitment period3. Who is
responsible for the ongoing safety evaluation of the investigational
product - correct answer- 1 or 2 only
According to ICH GCP if the trial is prematurely terminated or suspended
for any reason, the investigator/institution should do which of the
following as well as notifying IRB/IEC and local regulatory authorities:1.
Return all IMP to the sponsor immediately2. Contact all subjects to
ensure immediate return of all IMP3. Promptly inform the trial subject4.
Should assure appropriate therapy and treatment follow-up for the
subjects - correct answer- 3 & 4 only
According to ICH GCP Monitors should be appointed by the sponsor.
These monitors should be appropriately trained, and should have what
else? - correct answer- The scientific and/or clinical knowledge
needed to monitor the trial adequately
According to ICH GCP Non-therapeutic trials may be conducted in
subjects with consent of a legally acceptable representative provided the
following conditions are fulfilled: 1) The negative impact on the subject's
well-being is minimized and low 2) The trial is not prohibited by law 3)
The foreseeable risks to the subjects are low 4) The objectives of the trial
can not be met by means of a trial in subjects who can give informed
consent personally - correct answer- All of them
, According to ICH GCP Payments to a subject should be - correct
answer- prorated and not wholly contingent on completion of the
trial by the subject.
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: - correct answer- Writing
According to ICH GCP Section 5.8 Compensation to Subjects and
Investigators which of the following is not true: A) Sponsor should
provide insurance B) Sponsor should indemnify investigator against
claims arising from negligence C) Sponsor should indemnify investigator
against claims arising from malpractice D) both b and c - correct
answer- D
According to ICH GCP Source data should be attributable, legible,
contemporaneous, original, accurate, and complete. Changes to source
data should be _____________, should not obscure the original entry,
and should be explained if necessary (e.g., via an audit trail). - correct
answer- Traceable
According to ICH GCP The investigator should be thoroughly familiar
with the appropriate use of the investigational product(s), as described
in the: - correct answer- Protocol, investigators brochure, and in the
product information
