SOCRA CERTIFICATION EXAM QUESTIONS WITH
CORRECT ANSWERS 2025
04955D - ANSWER-auth code smh
allocation of responsibility - ANSWER-sponsor should define, establish, and allocate all trial related
functions
Are participants obliged to give a reason when withdrawing from a trial? - ANSWER-No, but if possible
they should
Are post-study events able to qualify for expedited reporting? - ANSWER-Yes.
Are prorated compensation models more ethical than entire completion models? - ANSWER-Yes! Good
to know! Can't unduly coerce them to remain in the study
Are reactions to placebo considered ADRs? - ANSWER-Generally, no. The sponsor can decide when it is
appropriate to report placebo reactions
Are there a lot of required documentations and records by the IRB? - ANSWER-Yes. Lots of written
procedures, must keep copies of meeting minutes, copies of correspondance, research proposals etc.
Everything needs to be documented!
Are there any exceptions to breaking the blind when a serious adr occurs? - ANSWER-If such a serious
event is one of the MAJOR study endpoints.... then it may be useful to find another way (with proper
authority)
Are there exceptions for parental consent when a child is neglected or abused? - ANSWER-Yes
Are there instances in which both parents need to consent for a child to participate in research? -
ANSWER-YES. I suppose more than minimal risk? of course, there are exceptions
SOCRA CERTIFICATION EXAM QUESTIONS WITH
CORRECT ANSWERS 2025
,SOCRA CERTIFICATION EXAM QUESTIONS WITH
CORRECT ANSWERS 2025
Are there protections for coerced abortion for research? - ANSWER-Yes. You cannot compensate for a
terminated pregnancy.The individuals doing the research cannot determine the viability of pregnancies
or timing of terminations.
Are there situations, other than a serious and unexpected ADR, which require expedited reporting? -
ANSWER-Yes. For example, if an expected reaction is happening at a higher-than-expected rate. A new
animal study finding. Lack of efficacy in patients with life threatening disease.
Belmont Report: Justice - ANSWER-fair balance between those who participate and those who benefit.
(good distribution of BURDENS vs. Benefits)
you can't study prisoners to benefit larger society (and other examples)
Beneficence (Definition) - ANSWER-Maximize possible benefits and minimize possible harms.
Can a clinical investigator be disqualified? Why might that be the case? - ANSWER-Yes - if repeatedly or
deliberately failed to comply with subparts, agreements etc, or falsified any information.
Can a special access be granted for small patient populations, i.e. orphan drugs, orphan conditions? -
ANSWER-Yes - special considerations.
Can an IND be deemed "inactive" but not "terminated"? - ANSWER-Yes. if no subjects are entered for 2
years or more, or if on clinical hold for 1 year, the IND can be placed on inactive status.
Can an informed consent contain exculpatory language? - ANSWER-NO! Cannot say things like "you are
waiving your right to damages" etc
Can an IRB suspend or terminate research? - ANSWER-Yes. If unanticipated harm, or if researchers are
not following IRB requirements
SOCRA CERTIFICATION EXAM QUESTIONS WITH
CORRECT ANSWERS 2025
, SOCRA CERTIFICATION EXAM QUESTIONS WITH
CORRECT ANSWERS 2025
Can drugs be imported and exported for clinical trials? - ANSWER-Yes, under specified circumstances
and with proper review etc.
Can FDA inspect whenever they want? - ANSWER-Yes i think so
Can sponsors charge for an investigational drug? - ANSWER-Yes, but it has to be regulated and approved
by the FDA. And they need to show proof that its efficacious. Also, the cost of the drug must be
burdensome on the sponsor in order for them to charge for it.
Can the FDA "rely" on an "external" FDA in a multi-national trial? - ANSWER-Yes - you can accept foreign
IND's if they were conducted under GCP etc, if the FDA can validate the data, and also need to submit
lots of regulatory stuff.
Can the FDA terminate an IND? - ANSWER-Yes, for mostly the same reasons why they would impose a
clinical hold
Centralized Monitoring - ANSWER-You don't physically travel to sites. You may randomly sample data to
check for errors, etc.
Changes to SOURCE DATA must be.... - ANSWER-TRACEABLE!!! (electronic audits or handwritten single
strikethorugh with date and initials!)
Closed system (FDA term) - ANSWER-Environment in which SYSTEM ACCESS is controlled by the same
people responsible for the content of the system (I.E. I control the Robotic Database access AND its
contents)
Contrast an adverse drug reaction with an adverse event - ANSWER-AEs don't have to be related to the
drug/intervention. For ADRs, there is some possibility they are related.
Describe (in brief) the 10 principles set forth by the Nuremburg Code - ANSWER-1. Voluntary Consent of
the subject
SOCRA CERTIFICATION EXAM QUESTIONS WITH
CORRECT ANSWERS 2025
CORRECT ANSWERS 2025
04955D - ANSWER-auth code smh
allocation of responsibility - ANSWER-sponsor should define, establish, and allocate all trial related
functions
Are participants obliged to give a reason when withdrawing from a trial? - ANSWER-No, but if possible
they should
Are post-study events able to qualify for expedited reporting? - ANSWER-Yes.
Are prorated compensation models more ethical than entire completion models? - ANSWER-Yes! Good
to know! Can't unduly coerce them to remain in the study
Are reactions to placebo considered ADRs? - ANSWER-Generally, no. The sponsor can decide when it is
appropriate to report placebo reactions
Are there a lot of required documentations and records by the IRB? - ANSWER-Yes. Lots of written
procedures, must keep copies of meeting minutes, copies of correspondance, research proposals etc.
Everything needs to be documented!
Are there any exceptions to breaking the blind when a serious adr occurs? - ANSWER-If such a serious
event is one of the MAJOR study endpoints.... then it may be useful to find another way (with proper
authority)
Are there exceptions for parental consent when a child is neglected or abused? - ANSWER-Yes
Are there instances in which both parents need to consent for a child to participate in research? -
ANSWER-YES. I suppose more than minimal risk? of course, there are exceptions
SOCRA CERTIFICATION EXAM QUESTIONS WITH
CORRECT ANSWERS 2025
,SOCRA CERTIFICATION EXAM QUESTIONS WITH
CORRECT ANSWERS 2025
Are there protections for coerced abortion for research? - ANSWER-Yes. You cannot compensate for a
terminated pregnancy.The individuals doing the research cannot determine the viability of pregnancies
or timing of terminations.
Are there situations, other than a serious and unexpected ADR, which require expedited reporting? -
ANSWER-Yes. For example, if an expected reaction is happening at a higher-than-expected rate. A new
animal study finding. Lack of efficacy in patients with life threatening disease.
Belmont Report: Justice - ANSWER-fair balance between those who participate and those who benefit.
(good distribution of BURDENS vs. Benefits)
you can't study prisoners to benefit larger society (and other examples)
Beneficence (Definition) - ANSWER-Maximize possible benefits and minimize possible harms.
Can a clinical investigator be disqualified? Why might that be the case? - ANSWER-Yes - if repeatedly or
deliberately failed to comply with subparts, agreements etc, or falsified any information.
Can a special access be granted for small patient populations, i.e. orphan drugs, orphan conditions? -
ANSWER-Yes - special considerations.
Can an IND be deemed "inactive" but not "terminated"? - ANSWER-Yes. if no subjects are entered for 2
years or more, or if on clinical hold for 1 year, the IND can be placed on inactive status.
Can an informed consent contain exculpatory language? - ANSWER-NO! Cannot say things like "you are
waiving your right to damages" etc
Can an IRB suspend or terminate research? - ANSWER-Yes. If unanticipated harm, or if researchers are
not following IRB requirements
SOCRA CERTIFICATION EXAM QUESTIONS WITH
CORRECT ANSWERS 2025
, SOCRA CERTIFICATION EXAM QUESTIONS WITH
CORRECT ANSWERS 2025
Can drugs be imported and exported for clinical trials? - ANSWER-Yes, under specified circumstances
and with proper review etc.
Can FDA inspect whenever they want? - ANSWER-Yes i think so
Can sponsors charge for an investigational drug? - ANSWER-Yes, but it has to be regulated and approved
by the FDA. And they need to show proof that its efficacious. Also, the cost of the drug must be
burdensome on the sponsor in order for them to charge for it.
Can the FDA "rely" on an "external" FDA in a multi-national trial? - ANSWER-Yes - you can accept foreign
IND's if they were conducted under GCP etc, if the FDA can validate the data, and also need to submit
lots of regulatory stuff.
Can the FDA terminate an IND? - ANSWER-Yes, for mostly the same reasons why they would impose a
clinical hold
Centralized Monitoring - ANSWER-You don't physically travel to sites. You may randomly sample data to
check for errors, etc.
Changes to SOURCE DATA must be.... - ANSWER-TRACEABLE!!! (electronic audits or handwritten single
strikethorugh with date and initials!)
Closed system (FDA term) - ANSWER-Environment in which SYSTEM ACCESS is controlled by the same
people responsible for the content of the system (I.E. I control the Robotic Database access AND its
contents)
Contrast an adverse drug reaction with an adverse event - ANSWER-AEs don't have to be related to the
drug/intervention. For ADRs, there is some possibility they are related.
Describe (in brief) the 10 principles set forth by the Nuremburg Code - ANSWER-1. Voluntary Consent of
the subject
SOCRA CERTIFICATION EXAM QUESTIONS WITH
CORRECT ANSWERS 2025
