ACRP-CP Certification Exam NEW 2024
What would be the first priority for an investigator when a subject wishes to withdraw prematurely from the trial? - ANSWERSTry to obtain the subject's reason for withdrawal.
CRO recently switched from paper CRF to an EDC system. The EDC system must confor...
ACRP-CP Certification Exam NEW 2024
What would be the first priority for an investigator when a subject wishes to withdraw
prematurely from the trial? - ANSWERSTry to obtain the subject's reason for
withdrawal.
CRO recently switched from paper CRF to an EDC system. The EDC system must
conform to the established requirements for - ANSWERSValidation
Accuracy
Reliability
Completeness
Part of a sponsor's responsibility pertaining to electronic trial data handling is to -
ANSWERSmaintain an audit trail, data trail, and edit trail.
A research subject's responsibilities for study participation should be described in the -
ANSWERSICF
What document would an investigator reference to learn more about the previous
clinical and nonclinical results of studies of the IP? - ANSWERSInvestigators brochure
During a multi site clinical study: whose responsibility is it to report subject recruitment
rate? - ANSWERSThe CRA
An unconscious adult subject was enrolled in a study after obtaining consent from an
LAR: and protocol therapy was initiated. The subject showed significant improvement in
his clinical condition: and regained consciousness. The Investigator should inform the
subject about the study and - ANSWERSObtain consent from the subject for the study
A site is in the start up phase of an industry sponsored phase 3 trial: and has received
IRB approval. The site can begin enrolling subjects after... - ANSWERSA signed clinical
trial agreement between the site and sponsor is in place.
A site is screening potential subjects for a study looking at mild cognitive impairment.
One of the inclusion criteria is a score of 25 or less on a psychometric test: a research
specific tool which measures cognitive ability. Which of the following individuals can
administer the psychometric test to the potential subjects? - ANSWERSA research
assistant who is certified to administer the psychometric test
A research study: in which there is no intended clinical benefit to the subject: is being
submitted to the IRB. What benefit information should be included in the ICF? -
ANSWERSWording indicating that there is no expected benefit should be included
A CRA notices during an onsite visit that the date on IRB approval letter for a protocol
is prior to the effective date indicated on the cover page of the protocol and the
,signatures of the investigator and sponsor. What should the CRA do FIRST? -
ANSWERSConfirm dates of initial receipt of the sponsor protocol and the IRB
submission dates.
In a multi arm: randomized clinical trial: one arm of the protocol was terminated due to
an increased risk of cancer in subjects. Who is responsible for providing a written report
to the IRB? - ANSWERSPI
Which of the following required elements should be included in a clinical trial protocol? -
ANSWERSSubject inclusion and exclusion criteria
Prior to archiving a study: documentation of IP destruction at the site should be filed in
the study files of the - ANSWERSPI and Sponsor
During a monitoring visit: what records would a CRA reference to verify a subject's
compliance to the study visit schedule and assessments? - ANSWERSElectronic
medical record
When considering participation in a study: the investigator should determine if he... -
ANSWERSSees enough patients who would qualify for the study
New safety information has become available from the Sponsor about the IP being
used in a clinical trial. The investigator must - ANSWERSSubmit a revised ICF to the
IRB noting the new safety information
Per ICH: an IRB must keep correspondence for at least how long after the completion
of a clinical trial? - ANSWERS3 Years
When would an impartial witness be needed during the consent process for an illiterate
subject? - ANSWERSTo observe the consent process
A study which seeks to determine the ideal dose and regimen of a new IP to treat
hypothyroidism is considered to be - ANSWERSPhase II
After completion of a study: the final trial close out monitoring report prepared by the
CRA should be filed in which of the following stakeholder files? - ANSWERSThe
sponsors files
A blood sample collection is required to screen for bloodborne pathogens before
subject could be enrolled in a study. Where will subjects find information of the
procedures and any foreseeable risks or inconveniences? - ANSWERSICF
When should a research study involving human subjects be registered in a publicly
accessible database? - ANSWERSBefore recruiting the first subject
, In the case of an incapacitated subject: who should receive a copy of the signed and
dated ICF? - ANSWERSThe subjects legally acceptable representative
A medical student is approaches by a faculty member for possible participation in a
cricothyroidotomy simulation research study. Which of the following increases risk to the
study? - ANSWERSConsenting in the presence of figure of authority
The clinical trial phase that focuses on safety and human pharmacology in healthy
volunteers - ANSWERSPhase I
Who is ultimately responsible for all aspects of the research conducted at a site? -
ANSWERSPrincipal investigator
An international quality standard that is provided by ICH E6(R2) describing safety:
accuracy of trials and credibility of data - ANSWERSGCP
What event resulted in the Nuremburg Cod of 1949 - ANSWERSNazi Medical
Experiments
Prior to archiving a study: documentation of IP destruction at the site should be filed in
the study files of the - ANSWERSPI and Sponsor
In the case of an incapacitated subject: who should receive a copy of the signed and
dated ICF? - ANSWERSThe subject's legally acceptable representative
Which of the following required elements should be included in a clinical trial protocol? -
ANSWERSThe subject inclusion and exclusion criteria
During a multi-site clinical study: whose responsibility is it to report subject recruitment
rate? - ANSWERSThe CRA
A study which seeks to determine the ideal dose and regimen of a new IP to treat
hypothyroidism is considered to be - ANSWERSPhase II
What document would an investigator reference to learn more about the previous
clinical and nonclinical results of studies of the IP? - ANSWERSIB
When considering participation in a study: the investigator should determine if he/she -
ANSWERSsees enough patients who would qualify for the study
When would an impartial witness be needed during the consent process for an illiterate
subject? - ANSWERSTo observe the consent process
During a monitoring visit: what records would a CRA reference to verify a subject's
compliance to the study visit schedule and assessments? - ANSWERSelectronic
medical record
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