MEGA SOCRA CCRP EXAM CONTENT questions
& answers
. Which of the following options describes the term "severe" in regards
to ICH? - answer The Intensity of a specific event
(Government programs) IRB may approve a consent procedure which
does not include, or alters, so or all of the elements of informed
consent, or waive the requirements of informed consent if the IRB finds
that - answer 1. The research or demonstration project is to be
conducted by or subject to the approval of state or local government
officials and is designed to study, evaluate, or otherwise examine: (i)
Public benefit of service programs; (ii) procedures for obtaining benefits
or services under those programs; (iii) possible changes in or
alternatives to those programs or procedures; or (iv) possible changes
in methods or levels of payment for benefits or services under those
programs
2. Research could not practically be carried out without the waiver or
alteration
21 CFR 11 - answer Electronic Records/Signatures
21 CFR 312 - answer IND
,21 CFR 50 - answer Protection of Human Subjets/Informed Consent
21 CFR 56 - answer IRB
21 CFR 812 - answer IDE
3 regulatory agency sponsors of ICH - answer European Union, Japan,
United States
45 CFR - answer The Common Rule
45 CFR Part B - answer Pregnant Women and Fetuses
45 CFR Part C - answer Prisoners
45 CFR Part D - answer Children
45 CFR Part E - answer IRBs
5 - answer The minimum number of IRB members
,A clinical trial is being conducted for hormone replacement. The trial
includes a diary. Which of the following would be considered an
objective parameter? - answer Episodes of vaginal bleeding
A clinical trial is being conducted to determine the safety and
tolerability of a new anti-emetic IP. The sponsor expects to enroll 20
subjects.
This would be considered a: - answer Phase 1 trial
A clinical trial protocol should include: - answer The subject's
responsibilities
Alternative treatments available to the subject
Indemnification statement
A competent adult subject signs a consent form with an "X" and
indicates approval. Which of the following is the BEST action for the CRC
to take? - answer Document why the subject signed with an "X"
A CRA calls to schedule a close-out visit. Per sponsor SOPs, the PI must
be present. The CRC informs the CRA that the PI will be out of the
country during the period when the CRA would like to visit. The CRC
should do which of the following? - answer Reschedule the close-out
visit for a later date
, A CRA is conducting a close-out visit at a site to review the regulatory
documents. The CRC has prepared the following documents to be filed
and/or sent to the sponsor:
treatment decoding documentation,
drug accountability log,
subject identification code list,
documentation of IP destruction,
and final report to the IRB/IEC.
Which of the following actions should the CRC perform? - answer 1)
Send the treatment decoding documentation to the sponsor
2) Remove the subject identification code list from the material to be
sent to the sponsor
3) Send copies of the IP destruction forms to the sponsor
A CRC has received three subject complaints of localized infection at the
venipuncture site. The CRC queries the phlebotomist and discovers that
when the first stick is unsuccessful, any additional sticks are done with
the same needle. This is in violation of the site's SOPs. Which of the
following actions should the CRC take? - answer Suggest review of
proper specimen collection for the
phlebotomist
Document and report the findings
& answers
. Which of the following options describes the term "severe" in regards
to ICH? - answer The Intensity of a specific event
(Government programs) IRB may approve a consent procedure which
does not include, or alters, so or all of the elements of informed
consent, or waive the requirements of informed consent if the IRB finds
that - answer 1. The research or demonstration project is to be
conducted by or subject to the approval of state or local government
officials and is designed to study, evaluate, or otherwise examine: (i)
Public benefit of service programs; (ii) procedures for obtaining benefits
or services under those programs; (iii) possible changes in or
alternatives to those programs or procedures; or (iv) possible changes
in methods or levels of payment for benefits or services under those
programs
2. Research could not practically be carried out without the waiver or
alteration
21 CFR 11 - answer Electronic Records/Signatures
21 CFR 312 - answer IND
,21 CFR 50 - answer Protection of Human Subjets/Informed Consent
21 CFR 56 - answer IRB
21 CFR 812 - answer IDE
3 regulatory agency sponsors of ICH - answer European Union, Japan,
United States
45 CFR - answer The Common Rule
45 CFR Part B - answer Pregnant Women and Fetuses
45 CFR Part C - answer Prisoners
45 CFR Part D - answer Children
45 CFR Part E - answer IRBs
5 - answer The minimum number of IRB members
,A clinical trial is being conducted for hormone replacement. The trial
includes a diary. Which of the following would be considered an
objective parameter? - answer Episodes of vaginal bleeding
A clinical trial is being conducted to determine the safety and
tolerability of a new anti-emetic IP. The sponsor expects to enroll 20
subjects.
This would be considered a: - answer Phase 1 trial
A clinical trial protocol should include: - answer The subject's
responsibilities
Alternative treatments available to the subject
Indemnification statement
A competent adult subject signs a consent form with an "X" and
indicates approval. Which of the following is the BEST action for the CRC
to take? - answer Document why the subject signed with an "X"
A CRA calls to schedule a close-out visit. Per sponsor SOPs, the PI must
be present. The CRC informs the CRA that the PI will be out of the
country during the period when the CRA would like to visit. The CRC
should do which of the following? - answer Reschedule the close-out
visit for a later date
, A CRA is conducting a close-out visit at a site to review the regulatory
documents. The CRC has prepared the following documents to be filed
and/or sent to the sponsor:
treatment decoding documentation,
drug accountability log,
subject identification code list,
documentation of IP destruction,
and final report to the IRB/IEC.
Which of the following actions should the CRC perform? - answer 1)
Send the treatment decoding documentation to the sponsor
2) Remove the subject identification code list from the material to be
sent to the sponsor
3) Send copies of the IP destruction forms to the sponsor
A CRC has received three subject complaints of localized infection at the
venipuncture site. The CRC queries the phlebotomist and discovers that
when the first stick is unsuccessful, any additional sticks are done with
the same needle. This is in violation of the site's SOPs. Which of the
following actions should the CRC take? - answer Suggest review of
proper specimen collection for the
phlebotomist
Document and report the findings
