SOCRA CERTIFICATION STUDY 2026 EXAM ACTUAL
QUESTIONS AND ANSWERS SURE A+
✔✔The contract research organization shall select a monitor that is
________________. - ✔✔-Qualified by experience
- Qualified by training
✔✔A ____ lists the investigator's education, training, and experience that qualifies the
investigator as an expert in the clinical investigation of the drug for the use under
investigation. - ✔✔1. Curriculum vitae
2. Statement of qualifications of the investigator
✔✔The sponsor shall monitor investigations to identify when an IRB determines that it
cannot approve the research because it does not meet the criteria for exception or
because of other relevant eithical concerns - ✔✔a. true X
b. false
✔✔Before the investigation begins, the sponsor shall give each participation clinical
investigator a/an _______. - ✔✔Investigator Brochure
✔✔____ means the party who submits a marketing application to FDA for approval of a
drug device or biologic product. - ✔✔Clinical Investigator
✔✔The applicant must completely and accurately disclose or certify information
concerning the financial interests of a clinical investigator who is a full-time or part-time
employee of the sponsor for each covered clinical study. - ✔✔a. true
b. false X
- Must Disclose everyone, not just those who are full time or part time.
✔✔What is an informed consent? - ✔✔What is informed consent? consent given by a
patient to a procedure after understanding the facts and the risks
, ✔✔What is 21 CFR 56.109 subpart C? - ✔✔IRB review of research
✔✔21 CFR 56 Subpart B is IRB documentation - ✔✔a. true
b. False X
- 21 CFR 56 subpart B is organization and personnel
✔✔The form ___ is used for investigational new drugs (or IND) - ✔✔1571
✔✔What is 21 CFR 50.25 Subpart B? - ✔✔Elements of Informed Consent
✔✔The "Doctor's Trial" prompted the Belmont Report - ✔✔a. true
b. false X
✔✔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
QUESTIONS AND ANSWERS SURE A+
✔✔The contract research organization shall select a monitor that is
________________. - ✔✔-Qualified by experience
- Qualified by training
✔✔A ____ lists the investigator's education, training, and experience that qualifies the
investigator as an expert in the clinical investigation of the drug for the use under
investigation. - ✔✔1. Curriculum vitae
2. Statement of qualifications of the investigator
✔✔The sponsor shall monitor investigations to identify when an IRB determines that it
cannot approve the research because it does not meet the criteria for exception or
because of other relevant eithical concerns - ✔✔a. true X
b. false
✔✔Before the investigation begins, the sponsor shall give each participation clinical
investigator a/an _______. - ✔✔Investigator Brochure
✔✔____ means the party who submits a marketing application to FDA for approval of a
drug device or biologic product. - ✔✔Clinical Investigator
✔✔The applicant must completely and accurately disclose or certify information
concerning the financial interests of a clinical investigator who is a full-time or part-time
employee of the sponsor for each covered clinical study. - ✔✔a. true
b. false X
- Must Disclose everyone, not just those who are full time or part time.
✔✔What is an informed consent? - ✔✔What is informed consent? consent given by a
patient to a procedure after understanding the facts and the risks
, ✔✔What is 21 CFR 56.109 subpart C? - ✔✔IRB review of research
✔✔21 CFR 56 Subpart B is IRB documentation - ✔✔a. true
b. False X
- 21 CFR 56 subpart B is organization and personnel
✔✔The form ___ is used for investigational new drugs (or IND) - ✔✔1571
✔✔What is 21 CFR 50.25 Subpart B? - ✔✔Elements of Informed Consent
✔✔The "Doctor's Trial" prompted the Belmont Report - ✔✔a. true
b. false X
✔✔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
