SOCRA PRACTICE TEST 2025 WITH WELL DETAILED SOLUTIONS ALREADY GRADED A+
Which of the following is a disclosure of financial interests form?
FDA Form 3455
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
Which of the following is a disclosure of financial interests form?
FDA Form 3455
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
