SOCRA CERTIFICATION EXAM WITH
CORRECT ACTUAL QUESTIONS AND
CORRECTLY WELL DEFINED ANSWERS
LATEST ALREADY GRADED A+ 2025 – 2026
Quick Overview: NUREMBURG CODE - ANSWERS-A set of 10 ethical principles
for human experimentation. Developed in 1947 as a result of trials held in
Nuremburg, Germany for medical personnel involved in the Nazi biomedical
experimentation/torture/murder in concentration camps.
Quick Overview: DECLARATION OF HELSINKI - ANSWERS-A set of ethical
principles for medical research on human subjects originally set forth in 1964.
Developed by the WORLD MEDICAL ASSOCIATION (WMA)
Quick Overview: ICH HARMONISED GUIDELINE FOR GCP - ANSWERS-GCP is
international guidelines for conduct of TRIALS. Developed by an international
health council in 1990s to harmonize international guidelines that were
already put forth. Meant to faciliate clinical trials internationally, especially
between US, EU, Japan, and Switzerland.
It serves to both protect subjects AND to assure data quality / good practice.
Quick Overview: Paperwork reduction act of 1995 - ANSWERS-The purpose
was to reduce the Burden of paperwork held by the public (or people
,involved in trials). Basically, before you have people fill out forms... it HAS to
be approved by Office of Management and Budget.
Why is the Belmont report such named? - ANSWERS-The Commission created
by the National Research Act held its deliberations at the Belmont
Conference Center of the Smithsonian.
Please name the 3 Broad Sections of the Belmont Report - ANSWERS-1.
Boundaries between Practice and Research
2. Basic Ethical Principles (there are 3)
3. Applications (there are 3)
What are the 3 basic ethical principles outlined in the belmont report? -
ANSWERS-Respect for Persons, Beneficence, and Justice
What are the 3 "Applications" Outlined in the Belmont report? - ANSWERS-
Informed Consent
Assessment of Risk and Benefits
Selection of Subjects
How does the Belmont report distinguish between Practice and Research? -
ANSWERS-Practice: Interventions SOLELY designed to benefit and individual,
already have a reasonable expectation of success.
Research: an activity to test a hypothesis, develop generalizable knowledge.
Formal protocol and procedures defined.
, respect for persons - ANSWERS-treating persons as autonomous agents and
protecting those with diminished autonomy (relates to children, prisoners,
mental disability, respect for peoples opinions and judgements)
Beneficence (Definition) - ANSWERS-Maximize possible benefits and
minimize possible harms.
What controls should an E-SIGNATURE contain? - ANSWERS-Employ at least 2
identification components - such as an identification code AND a password.
Name some CONTROLS for the identification components (i.e. identification
code and password) for e-signature? - ANSWERS-1. no 2 people should have
the same identification controls (password... code)
2. Identification codes and passwords should be periodically checked, revised,
etc.
3. Deauthorize lost, stolen, missing codes and passwords
4. Periodically test your devices that generate these codes
Can an informed consent contain exculpatory language? - ANSWERS-NO!
Cannot say things like "you are waiving your right to damages" etc
When may an experimental drug or device be used on a patient WITHOUT
informed consent? ((EMERGENCY USE)) - ANSWERS-1. the investigator and an
independent physician agree that the patient is -life threatening situation
-informed consent cannot be obtained
- there is no time to obtain consent from th esubject's legal representation
-there is no recognized therapy that provides equal or greater likelihood of
saving life
CORRECT ACTUAL QUESTIONS AND
CORRECTLY WELL DEFINED ANSWERS
LATEST ALREADY GRADED A+ 2025 – 2026
Quick Overview: NUREMBURG CODE - ANSWERS-A set of 10 ethical principles
for human experimentation. Developed in 1947 as a result of trials held in
Nuremburg, Germany for medical personnel involved in the Nazi biomedical
experimentation/torture/murder in concentration camps.
Quick Overview: DECLARATION OF HELSINKI - ANSWERS-A set of ethical
principles for medical research on human subjects originally set forth in 1964.
Developed by the WORLD MEDICAL ASSOCIATION (WMA)
Quick Overview: ICH HARMONISED GUIDELINE FOR GCP - ANSWERS-GCP is
international guidelines for conduct of TRIALS. Developed by an international
health council in 1990s to harmonize international guidelines that were
already put forth. Meant to faciliate clinical trials internationally, especially
between US, EU, Japan, and Switzerland.
It serves to both protect subjects AND to assure data quality / good practice.
Quick Overview: Paperwork reduction act of 1995 - ANSWERS-The purpose
was to reduce the Burden of paperwork held by the public (or people
,involved in trials). Basically, before you have people fill out forms... it HAS to
be approved by Office of Management and Budget.
Why is the Belmont report such named? - ANSWERS-The Commission created
by the National Research Act held its deliberations at the Belmont
Conference Center of the Smithsonian.
Please name the 3 Broad Sections of the Belmont Report - ANSWERS-1.
Boundaries between Practice and Research
2. Basic Ethical Principles (there are 3)
3. Applications (there are 3)
What are the 3 basic ethical principles outlined in the belmont report? -
ANSWERS-Respect for Persons, Beneficence, and Justice
What are the 3 "Applications" Outlined in the Belmont report? - ANSWERS-
Informed Consent
Assessment of Risk and Benefits
Selection of Subjects
How does the Belmont report distinguish between Practice and Research? -
ANSWERS-Practice: Interventions SOLELY designed to benefit and individual,
already have a reasonable expectation of success.
Research: an activity to test a hypothesis, develop generalizable knowledge.
Formal protocol and procedures defined.
, respect for persons - ANSWERS-treating persons as autonomous agents and
protecting those with diminished autonomy (relates to children, prisoners,
mental disability, respect for peoples opinions and judgements)
Beneficence (Definition) - ANSWERS-Maximize possible benefits and
minimize possible harms.
What controls should an E-SIGNATURE contain? - ANSWERS-Employ at least 2
identification components - such as an identification code AND a password.
Name some CONTROLS for the identification components (i.e. identification
code and password) for e-signature? - ANSWERS-1. no 2 people should have
the same identification controls (password... code)
2. Identification codes and passwords should be periodically checked, revised,
etc.
3. Deauthorize lost, stolen, missing codes and passwords
4. Periodically test your devices that generate these codes
Can an informed consent contain exculpatory language? - ANSWERS-NO!
Cannot say things like "you are waiving your right to damages" etc
When may an experimental drug or device be used on a patient WITHOUT
informed consent? ((EMERGENCY USE)) - ANSWERS-1. the investigator and an
independent physician agree that the patient is -life threatening situation
-informed consent cannot be obtained
- there is no time to obtain consent from th esubject's legal representation
-there is no recognized therapy that provides equal or greater likelihood of
saving life
