Belmont Report was created as part of? Correct Answer: The national Research Act of 1974.
Who was the Belmont Report formulated by? Correct Answer: The National Commission for the protection of human subjects in biomedical and behavioral research.
What year was the publication of the FDA re...
SOCRA- 2022 QUESTIONS AND
ANSWERS ALL CORRECT
Belmont Report was created as part of? Correct Answer: The national Research Act of 1974.
Who was the Belmont Report formulated by? Correct Answer: The National Commission for
the protection of human subjects in biomedical and behavioral research.
What year was the publication of the FDA regulations made? Correct Answer: 1980 *1981 for
the HHS and revised FDA Regulations.
What year was GCP and HIPAA created? Correct Answer: 1996
What is the National Research Act? Correct Answer: A set of regulations for the protection of
human participants in research, mandated by congress in 1974, which lead to the Belmont
Report.
What is GCP? Correct Answer: Good Clinical Practice- Guidelines developed by the ICH for
global implementation on April 30, 1996
EU, Japan, USA
Australia, Canada, Nordic Countries and WHO.
What is the purpose of ICH? Correct Answer: International Conference of Harmonization- an
attempt to streamline the process for developing and marketing new drugs internationally.
*Eliminate duplicate research.
What are the ethical standards the ICH documents are based off of? Correct Answer:
Declaration of Helsinki
The ICH is concerned with harmonization of what three regions? Correct Answer: European
Union, Japan, USA. *Additional countries include: Australia, Canada, Nordic countries and
WHO.
Important ethical principals that were the result of experimentations in the concentration camps
during WW||? Correct Answer: Nuremberg Code
The organization that developed the Declaration of Helsinki? Correct Answer: World Medical
Association.
Who does the Declaration of Helsinki mainly address? Correct Answer: Physicians
Who is Peter Buxton? Correct Answer: The journalist that leaked Tuskegee to the press.
,Who is Henry Beecher? Correct Answer: The journalist that published a manuscript in the New
England Journal of Medicine presenting evidence of wide spread unethical and systematic
problems in research.
How long did the Tuskegee Syphilis trials last? Correct Answer: 1932-1972
The direct result of the Tuskegee Syphilis Trail of 1979. Correct Answer: Belmont Report
What two ethical works did the Nuremberg Code influence? Correct Answer: 1. Belmont Report
2. Declaration of Helsinki
Importance of the Belmont Report (1974)? Correct Answer: Boundaries between Practice and
Research.
Basic Ethical Principals:
-Respect for persons
-Beneficence
-Justice
Applications:
-Informed Consent
-Assessment of risk to benefit
- Selection of subjects
The 1947 Doctor's Trial Judgment resulted in what? Correct Answer: The Nuremberg Code
Exempt Research Correct Answer: Exempt from regulations described in the DHHS regulations.
(46.104)
Curriculum Vitae Correct Answer: Also known as CV, statement of qualifications. (312.23)
Oral Consent Correct Answer: 1. Requires a witness.
2. Subject must sign short form.
3. Witness will sign short form and summary of what was said.
(50.27)
Unanticipated Adverse Device Effect Correct Answer: Effecting safety/ health or any life-
threatening problem or death caused by or associated to device. (812.3)
Historical Controls Correct Answer: Prior data from patients with a similar disease to be studied
or data from the same patient in crossover study.
Essential Documents Correct Answer: Documents that individually and collectively permit
evaluation of the conduct of a study and the
quality of the data produced. (GCP)
, Digital signature Correct Answer: An electronic signature based upon cryptographic methods of
originator authentication, computed
by using a set of rules and a set of parameters such that the identity of the signer and the integrity
of the data can be verified. (11.3)
CAPA Correct Answer: Corrective and Preventive Action Plans. *IRB can request one. They
can also be done proactively.
UPIRSO Correct Answer: Unanticipated Problems Involving Risk to Participants or Others.
Excipients Correct Answer: Inactive substances used as a carrier for the active ingredients of a
medication.
Parallel Group Correct Answer: A study design that focuses on efficacy and safety.
Crossover Correct Answer: A study design that focuses on bioequivalence, can also help
determine if generic drugs are interchangeable.
Pre- study Visit Correct Answer: SQV's; also knows as: site selection visit, site qualification
visit.
Conducted to determined if the P.I. and clinical staff have the capacity to conduct a study. The
P.I. and study coordinator must be present (at the very least), Pharmacy, if available.
Initiation Visit Correct Answer: SIV's
Where the research team will get adequate training from the sponsor (or CRO) on the protocol.
This usually happens after all regulatory documents have been collected and IRB approval has
been obtained.
Investigator meeting Correct Answer: P.I and other study staff invited to participate to go over
the study details to the sponsor/ CRO.
Monitor Visits Correct Answer: Periodic monitor visits help by the sponsor/CRO will developed
(determined by the complexity and enrollment of the study) a monitor plan. Verification of how
the study is being conducted is the main focus. The contract agreement will have the frequency
and length of visits.
Close- out visit Correct Answer: Conducted at the end/ completion of a study. This can
sometimes be included within final monitor visit. This visit is used to tie up lose ends.
FWA Correct Answer: Federal wide Assurance; the only assurance accepted and approved by
OHRP for institutions engaged in non- exempt human subject research conducted or supported
by HHS. This indicated that the institution commits to HHS that they will comply with
45CFR46.
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