SOCRA CERTIFICATION UPDATED EXAM 2026
QUESTIONS AND ANSWERS SURE A+
✔✔Randomization - ✔✔The process of assigning trial subjects to treatment or control
groups using an element of chance to determine the assignments in order to reduce
bias. (ICH GCP E6 1.48)
✔✔Regulatory Authorities - ✔✔Bodies having the power to regulate. In the ICH GCP
guideline that guidelines the expression Regulatory Authorities includes the authorities
that review submitted clinical data.
✔✔Form 1572 - ✔✔Statement of investigator for IND
✔✔Form 1571 - ✔✔Cover sheet for an IND application
✔✔Private Information - ✔✔- information about behavior which occurs in a context in
which an individual can reasonably expect that no observation or recording is taking
place
- information which has been provided for a specified purpose by an individual and
which the individual can reasonably expect will not be made public (e.g. medical record)
✔✔IRB membership requirements according to 45 CFR 46 - ✔✔- minimum of 5
members
- IRB must be qualified through experience, expertise, diversity
- diversity with respect to race, gender, cultural background
- cannot consist of members of one profession
- at least one member must have a primary concern in a scientific area and one in a
non-scientific area
- at least one member not affiliated with the institution
✔✔Circumstances/conditions required for informed consent - ✔✔- subject has had
sufficient opportunity to consider whether to participate
- the possibility of coercion or undue influence is minimized
, ✔✔Informed Consent MUST Contain: - ✔✔- explanation of purpose of research
- duration of participation
- description of procedures to be followed
- identification of any procedures which are experimental
- any foreseeable risks or discomfort
- statement about potential benefits to subjects
- statement if no reasonable alternative procedures or treatments are available to
subjects
- for > minimal risk, a statement about compensation and if medical treatment is
available for injuries
- statement of who to contact in the event of research-related injury
✔✔Informed Consent ADDITIONAL Elements: - ✔✔- risk to embyro or fetus
- termination procedures
- costs to study subjects
- approximate number of study subjects
- a statement of new findings when they may impact a subject's willingness to
participate
✔✔Oral consent - ✔✔- requires a witness
- subject must sign short form only
- witness must sign both short form and summary of what was said
✔✔Waiver of Signed Informed Consent - ✔✔- if the only record linking the subject to the
research would be the consent document and the principal risk would result from breach
in confidentiality
- the research presents no more than minimal risk of harm to subjects and involves no
procedures for which written consent is normally required outside the context of
research
✔✔Types of federally-funded research that may be done using prisoners as subjects -
✔✔- possible causes, effects, and processes of incarceration and criminal behavior
- prisons as institutional structures or prisoners as incarcerated persons
- conditions particularly affecting prisoners
- practices aimed at improving the health or well-being of prisoners
✔✔3 regulatory agency sponsors of ICH - ✔✔European Union, Japan, United States
✔✔What ethical standards are the ICH document based on? - ✔✔Declaration of
Helsinki
✔✔What special population must the IRB pay special attention to? - ✔✔Vulnerable
subjects
QUESTIONS AND ANSWERS SURE A+
✔✔Randomization - ✔✔The process of assigning trial subjects to treatment or control
groups using an element of chance to determine the assignments in order to reduce
bias. (ICH GCP E6 1.48)
✔✔Regulatory Authorities - ✔✔Bodies having the power to regulate. In the ICH GCP
guideline that guidelines the expression Regulatory Authorities includes the authorities
that review submitted clinical data.
✔✔Form 1572 - ✔✔Statement of investigator for IND
✔✔Form 1571 - ✔✔Cover sheet for an IND application
✔✔Private Information - ✔✔- information about behavior which occurs in a context in
which an individual can reasonably expect that no observation or recording is taking
place
- information which has been provided for a specified purpose by an individual and
which the individual can reasonably expect will not be made public (e.g. medical record)
✔✔IRB membership requirements according to 45 CFR 46 - ✔✔- minimum of 5
members
- IRB must be qualified through experience, expertise, diversity
- diversity with respect to race, gender, cultural background
- cannot consist of members of one profession
- at least one member must have a primary concern in a scientific area and one in a
non-scientific area
- at least one member not affiliated with the institution
✔✔Circumstances/conditions required for informed consent - ✔✔- subject has had
sufficient opportunity to consider whether to participate
- the possibility of coercion or undue influence is minimized
, ✔✔Informed Consent MUST Contain: - ✔✔- explanation of purpose of research
- duration of participation
- description of procedures to be followed
- identification of any procedures which are experimental
- any foreseeable risks or discomfort
- statement about potential benefits to subjects
- statement if no reasonable alternative procedures or treatments are available to
subjects
- for > minimal risk, a statement about compensation and if medical treatment is
available for injuries
- statement of who to contact in the event of research-related injury
✔✔Informed Consent ADDITIONAL Elements: - ✔✔- risk to embyro or fetus
- termination procedures
- costs to study subjects
- approximate number of study subjects
- a statement of new findings when they may impact a subject's willingness to
participate
✔✔Oral consent - ✔✔- requires a witness
- subject must sign short form only
- witness must sign both short form and summary of what was said
✔✔Waiver of Signed Informed Consent - ✔✔- if the only record linking the subject to the
research would be the consent document and the principal risk would result from breach
in confidentiality
- the research presents no more than minimal risk of harm to subjects and involves no
procedures for which written consent is normally required outside the context of
research
✔✔Types of federally-funded research that may be done using prisoners as subjects -
✔✔- possible causes, effects, and processes of incarceration and criminal behavior
- prisons as institutional structures or prisoners as incarcerated persons
- conditions particularly affecting prisoners
- practices aimed at improving the health or well-being of prisoners
✔✔3 regulatory agency sponsors of ICH - ✔✔European Union, Japan, United States
✔✔What ethical standards are the ICH document based on? - ✔✔Declaration of
Helsinki
✔✔What special population must the IRB pay special attention to? - ✔✔Vulnerable
subjects
