SOCRA CERTIFICATION EXAM QUESTIONS WITH
CORRECT ANSWERS 2025
The objective of ICH-GCP - Is to provide a unified standard for the European union (EU), Japan and the
US (along with Australia, Canada and the Nordic countries and the WHO) to facilitate the mutual
acceptance of the clinical data by the regulatory authorities in these jurisdictions
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 T/F - True
The principles of ICH-GCP - -Clinical trials should be conducted in accordance with the ethical principles
that have their origin in the deceleration of helenski
-A trial should be initiated only if the anticipated benefits justify the risks
-the rights, safety and well-being of the trial subjects are most important considerations and should
prevail over interests of science or society
-the available nonclinical and clinical information on an investigational product should be adequate to
support the proposed clinical trial
-clinical trials should be scientifically sound, and described in a clear, detailed protocol
- a trial should be conducted in compliance with protocol that has received prior institutional review
board (IRB) / independent ethics comitte (IEC) approval / favorable option
-the medical care given, and medical decisions made on behalf of, subjects should always be the
responsibility of a qualified physician or, when appropriate of a qualified dentist
-each individual involved in conducting a trial should be qualified by education, training and experience
to perform their respective tasks
-freely given informed consent should be obtained from every subject prior to clinical trial preparation
-all clinical trial information should be recorded, handled, and stored in a way that allows its accurate
reporting, interpretation and verification
-the confidentiality of records that could identify subjects should be protected, respecting the privacy
and confidentiality rules in accordance with the applicable regulatory requirements
-investigational products should be manufactured, handled, and stored in accordance with applicable
good manufacturing practice (GMP). They should be used in accordance with the approved protocol
-systems with procedures that assure the quality of every aspect of the trial should be implemented
SOCRA CERTIFICATION EXAM QUESTIONS WITH
CORRECT ANSWERS 2025
,SOCRA CERTIFICATION EXAM QUESTIONS WITH
CORRECT ANSWERS 2025
The sponsor should... - When using electronic trial data handling and/or remote electronic trial data
systems:
-ensure and document that the electronic data system conforms to the sponsors established
requirements for completeness, accuracy, reliability and consistent intended performance
-Maintains SOP's for using these systems
-Ensures that the systems are designed to permit data changes in such a way that data changes are
documented and that there is no deletion of entered data
-Maintain a security system that prevents unauthorized access to the data
-Maintain a list of individuals who are authorized to make data changes
-Maintain adequate backup of the data
-Safeguard the blinding (maintain the blinding during DE and processing)
The World Medical Association (WMA) ethical principals for medical research involving human subjects
is called? - The Declaration of Helsinki
Today the Belmont Report Serves.. - As a historical document and provides the moral framework for
understanding regulations in the US on the uses of humans in experimental research
Tuskegee Syphilis Study - (1932-1972) prompted the belmont report
Conducted by the US Public Heath Service to study the natural progression of untreated syphilis in rural
African american men who thought they were receiving free healthcare from the US government
In 1947 the treatment for syphilis (penicillin) had become standard trx - the experiment continued
Unexpected Adverse Drug Reaction (UADR) - An adverse reaction, the nature or severity of of which is
not consistent with the applicable product information (eg. investigators brochure for an unapproved
investigational product or package insert/summary of product characteristics for an approved product
SOCRA CERTIFICATION EXAM QUESTIONS WITH
CORRECT ANSWERS 2025
, SOCRA CERTIFICATION EXAM QUESTIONS WITH
CORRECT ANSWERS 2025
Vulnerable Subjects - Individuals whose willingness to volunteer in a clinical trial may be unduly
influenced by the expectation, whether justified or not, of benefits associated with participation, or of a
retaliatory response from senior members of a hierarchy in case of refusal to participate. Examples are
members of a group with a hierarchical structure, such as medical, pharmacy, dental, and nursing
students, subordinate hospital and laboratory personnel, employees of the pharmaceutical industry,
members of the armed forces, and persons kept in detention. Other vulnerable subjects include patients
with incurable diseases, persons in nursing homes, unemployed or impoverished persons, patients in
emergency situations, ethnic minority groups, homeless persons, nomads, refugees, minors, and those
incapable of giving consent.
What are the applications for the Belmont Report? - 1. Informed Consent
2. Assessment of Risk and Benefits
3. Selection of Subjects
What are the three main basic ethical principles of the Belmont Report? - 1.Respect for Persons
2. Beneficence
3. Justice
What best describes the goals of an investigators meeting - Review the protocol and CRF with the
clinical site personnel
What is HHS? - Department of Health and Human Services
Who can vote/provide opinion on a trial related matter - Only those members who are independent of
the investigator and the sponsor of the trial
Who developed the Declaration of Helsinki and why - The World Medical Associated (WMA) - as a
statement of ethical principals for medical research involving human subjects, including research on
identifiable human material and data
SOCRA CERTIFICATION EXAM QUESTIONS WITH
CORRECT ANSWERS 2025
CORRECT ANSWERS 2025
The objective of ICH-GCP - Is to provide a unified standard for the European union (EU), Japan and the
US (along with Australia, Canada and the Nordic countries and the WHO) to facilitate the mutual
acceptance of the clinical data by the regulatory authorities in these jurisdictions
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 T/F - True
The principles of ICH-GCP - -Clinical trials should be conducted in accordance with the ethical principles
that have their origin in the deceleration of helenski
-A trial should be initiated only if the anticipated benefits justify the risks
-the rights, safety and well-being of the trial subjects are most important considerations and should
prevail over interests of science or society
-the available nonclinical and clinical information on an investigational product should be adequate to
support the proposed clinical trial
-clinical trials should be scientifically sound, and described in a clear, detailed protocol
- a trial should be conducted in compliance with protocol that has received prior institutional review
board (IRB) / independent ethics comitte (IEC) approval / favorable option
-the medical care given, and medical decisions made on behalf of, subjects should always be the
responsibility of a qualified physician or, when appropriate of a qualified dentist
-each individual involved in conducting a trial should be qualified by education, training and experience
to perform their respective tasks
-freely given informed consent should be obtained from every subject prior to clinical trial preparation
-all clinical trial information should be recorded, handled, and stored in a way that allows its accurate
reporting, interpretation and verification
-the confidentiality of records that could identify subjects should be protected, respecting the privacy
and confidentiality rules in accordance with the applicable regulatory requirements
-investigational products should be manufactured, handled, and stored in accordance with applicable
good manufacturing practice (GMP). They should be used in accordance with the approved protocol
-systems with procedures that assure the quality of every aspect of the trial should be implemented
SOCRA CERTIFICATION EXAM QUESTIONS WITH
CORRECT ANSWERS 2025
,SOCRA CERTIFICATION EXAM QUESTIONS WITH
CORRECT ANSWERS 2025
The sponsor should... - When using electronic trial data handling and/or remote electronic trial data
systems:
-ensure and document that the electronic data system conforms to the sponsors established
requirements for completeness, accuracy, reliability and consistent intended performance
-Maintains SOP's for using these systems
-Ensures that the systems are designed to permit data changes in such a way that data changes are
documented and that there is no deletion of entered data
-Maintain a security system that prevents unauthorized access to the data
-Maintain a list of individuals who are authorized to make data changes
-Maintain adequate backup of the data
-Safeguard the blinding (maintain the blinding during DE and processing)
The World Medical Association (WMA) ethical principals for medical research involving human subjects
is called? - The Declaration of Helsinki
Today the Belmont Report Serves.. - As a historical document and provides the moral framework for
understanding regulations in the US on the uses of humans in experimental research
Tuskegee Syphilis Study - (1932-1972) prompted the belmont report
Conducted by the US Public Heath Service to study the natural progression of untreated syphilis in rural
African american men who thought they were receiving free healthcare from the US government
In 1947 the treatment for syphilis (penicillin) had become standard trx - the experiment continued
Unexpected Adverse Drug Reaction (UADR) - An adverse reaction, the nature or severity of of which is
not consistent with the applicable product information (eg. investigators brochure for an unapproved
investigational product or package insert/summary of product characteristics for an approved product
SOCRA CERTIFICATION EXAM QUESTIONS WITH
CORRECT ANSWERS 2025
, SOCRA CERTIFICATION EXAM QUESTIONS WITH
CORRECT ANSWERS 2025
Vulnerable Subjects - Individuals whose willingness to volunteer in a clinical trial may be unduly
influenced by the expectation, whether justified or not, of benefits associated with participation, or of a
retaliatory response from senior members of a hierarchy in case of refusal to participate. Examples are
members of a group with a hierarchical structure, such as medical, pharmacy, dental, and nursing
students, subordinate hospital and laboratory personnel, employees of the pharmaceutical industry,
members of the armed forces, and persons kept in detention. Other vulnerable subjects include patients
with incurable diseases, persons in nursing homes, unemployed or impoverished persons, patients in
emergency situations, ethnic minority groups, homeless persons, nomads, refugees, minors, and those
incapable of giving consent.
What are the applications for the Belmont Report? - 1. Informed Consent
2. Assessment of Risk and Benefits
3. Selection of Subjects
What are the three main basic ethical principles of the Belmont Report? - 1.Respect for Persons
2. Beneficence
3. Justice
What best describes the goals of an investigators meeting - Review the protocol and CRF with the
clinical site personnel
What is HHS? - Department of Health and Human Services
Who can vote/provide opinion on a trial related matter - Only those members who are independent of
the investigator and the sponsor of the trial
Who developed the Declaration of Helsinki and why - The World Medical Associated (WMA) - as a
statement of ethical principals for medical research involving human subjects, including research on
identifiable human material and data
SOCRA CERTIFICATION EXAM QUESTIONS WITH
CORRECT ANSWERS 2025
