SOCRA UPDATED EVALUATION ACTUAL QUESTIONS AND
SOLUTIONS RATED A+
✔✔What is 21 CFR 50.27? - ✔✔Documentation of informed consent
✔✔The objective of the ICH GCP Guideline is to provide a unified standard for the
European Union (EU, Japan and the Untied States to facilitate the mutual acceptance of
clinical data by the regulatory authorities in these jurisdictions - ✔✔a. true X
b. false
✔✔In the preapproval clinical experience with a new medicinal project or its new
usages, particularly as therapuyetic dose(s) may not be established: all noxious and
unintended responses to a medicianal product related to any dose should be
considered ____ - ✔✔Adverse drug reactions, ADR
✔✔_____ is permission to examine, analyze, verify, and reproduce any records and
reports that are important to evaluation of a clinical trial. - ✔✔Direct Access
✔✔What is 21 CFR 50.53 Subpart D? - ✔✔Clinical investigations involving greater than
minimal risk and no prospect of direct benefit to individual subjects, but likely to yield
generalization knowledge about the subjects' disorder or condition - Children
✔✔Who monitors the progress of all clinical trial investigations being conducted under
its IND? - ✔✔The Sponsor
✔✔What is 21 CFR 56.110 Subpart C? - ✔✔Expedited review procedures for certain
kinds of research involving no more than minimal risk for minor changes in approved
research
✔✔The World Medical Association (WMA) ethical principals for medical research
involving human subjects is called? - ✔✔The Declaration of Helsinki
✔✔What is 45CFR46? - ✔✔HHS - Protection of Human Health Subjects
✔✔What is 45 CFR 46 Subpart B? - ✔✔Additional Protections for Pregnant Women,
Human Fetuses and Neonates Involved in Research
✔✔When a short form is used for Informed Consent, the witness must sign either the
short form or the summary - ✔✔a. true
b. false X
- the witness must sign BOTH the short form and the summary.
, ✔✔The Code of Federal Regulations that applies to Electronic Records; Electronic
Signatures is.. - ✔✔21 CFR 11
✔✔Which of the following are necessary to satisfy 21 CFR 50.23 Subpart B? - ✔✔-
There is available no alternative method of approved or generally recognized therapy
that provides an equal or greater likelihood of saving the life of the subject
- The human subject is confronted by a life-threatening situation necessitating the use of
the test article
- Informed consent cannot be obtained from the subject because of an inability to
communicate with or obtain legally effective consent from, the subject
- Time is not sufficient to obtain consent from the subject's legal representative.
✔✔What is 21 CFR 50.24 subpart B? - ✔✔Exception from Informed Consent
Requirements for Emergency Research
✔✔That is the minimum number of IRB members? - ✔✔5
✔✔What is the federal department responsible for helping people of Canada maintain
and improve their health? - ✔✔Health Canada
✔✔The object of GCP is part of the ICH mission statement - ✔✔a. true X
b. false
✔✔A (n) _____ is a printed, optical or electronic document designed to record all of the
protocol required information to be reported to the sponsor on each trial subject -
✔✔Case Report Form, CRF
✔✔What do the HHS stand for? - ✔✔Department of Health and Human Services
✔✔What is 21 CFR 50.20 subpart B? - ✔✔General Requirements for Informed Consent
Requirements for Emergency Research
✔✔When a short form is used for Informed Consent, the partient signs the short form
ONLY and the receives a copy of both the summary and the short form - ✔✔a. true X
b. false
✔✔What is 45 CFR 46 subpart A? - ✔✔Basic HHS policy for Protection of Human
Research Subjects
✔✔This form is used for the voluntary reporting of adverse events and product
problems - ✔✔3500, FDA 3500
SOLUTIONS RATED A+
✔✔What is 21 CFR 50.27? - ✔✔Documentation of informed consent
✔✔The objective of the ICH GCP Guideline is to provide a unified standard for the
European Union (EU, Japan and the Untied States to facilitate the mutual acceptance of
clinical data by the regulatory authorities in these jurisdictions - ✔✔a. true X
b. false
✔✔In the preapproval clinical experience with a new medicinal project or its new
usages, particularly as therapuyetic dose(s) may not be established: all noxious and
unintended responses to a medicianal product related to any dose should be
considered ____ - ✔✔Adverse drug reactions, ADR
✔✔_____ is permission to examine, analyze, verify, and reproduce any records and
reports that are important to evaluation of a clinical trial. - ✔✔Direct Access
✔✔What is 21 CFR 50.53 Subpart D? - ✔✔Clinical investigations involving greater than
minimal risk and no prospect of direct benefit to individual subjects, but likely to yield
generalization knowledge about the subjects' disorder or condition - Children
✔✔Who monitors the progress of all clinical trial investigations being conducted under
its IND? - ✔✔The Sponsor
✔✔What is 21 CFR 56.110 Subpart C? - ✔✔Expedited review procedures for certain
kinds of research involving no more than minimal risk for minor changes in approved
research
✔✔The World Medical Association (WMA) ethical principals for medical research
involving human subjects is called? - ✔✔The Declaration of Helsinki
✔✔What is 45CFR46? - ✔✔HHS - Protection of Human Health Subjects
✔✔What is 45 CFR 46 Subpart B? - ✔✔Additional Protections for Pregnant Women,
Human Fetuses and Neonates Involved in Research
✔✔When a short form is used for Informed Consent, the witness must sign either the
short form or the summary - ✔✔a. true
b. false X
- the witness must sign BOTH the short form and the summary.
, ✔✔The Code of Federal Regulations that applies to Electronic Records; Electronic
Signatures is.. - ✔✔21 CFR 11
✔✔Which of the following are necessary to satisfy 21 CFR 50.23 Subpart B? - ✔✔-
There is available no alternative method of approved or generally recognized therapy
that provides an equal or greater likelihood of saving the life of the subject
- The human subject is confronted by a life-threatening situation necessitating the use of
the test article
- Informed consent cannot be obtained from the subject because of an inability to
communicate with or obtain legally effective consent from, the subject
- Time is not sufficient to obtain consent from the subject's legal representative.
✔✔What is 21 CFR 50.24 subpart B? - ✔✔Exception from Informed Consent
Requirements for Emergency Research
✔✔That is the minimum number of IRB members? - ✔✔5
✔✔What is the federal department responsible for helping people of Canada maintain
and improve their health? - ✔✔Health Canada
✔✔The object of GCP is part of the ICH mission statement - ✔✔a. true X
b. false
✔✔A (n) _____ is a printed, optical or electronic document designed to record all of the
protocol required information to be reported to the sponsor on each trial subject -
✔✔Case Report Form, CRF
✔✔What do the HHS stand for? - ✔✔Department of Health and Human Services
✔✔What is 21 CFR 50.20 subpart B? - ✔✔General Requirements for Informed Consent
Requirements for Emergency Research
✔✔When a short form is used for Informed Consent, the partient signs the short form
ONLY and the receives a copy of both the summary and the short form - ✔✔a. true X
b. false
✔✔What is 45 CFR 46 subpart A? - ✔✔Basic HHS policy for Protection of Human
Research Subjects
✔✔This form is used for the voluntary reporting of adverse events and product
problems - ✔✔3500, FDA 3500
