CCRP ACTUAL 2026 TEST PAPER QUESTIONS AND
SOLUTIONS RATED A+
✔✔Who developed the Declaration of Helsinki? - ✔✔World Medical Association (WMA)
✔✔What is the Declaration of Helsinki? - ✔✔Document that laid out general principles
physicians should follow to conduct research with humans, based on Nuremberg Code.
First effort of medical community to regulate itself
✔✔When was the Belmont Report released? - ✔✔1979
✔✔Who created the Belmont Report? - ✔✔National Commission for the Protection of
Human Subjects of Biomedical and Behavioral Research (at direction of National
Research Act 1974)
✔✔What are the 3 principles in the Belmont Report? - ✔✔1) Respect for Persons:
informed consent required and individuals with diminished autonomy get special
protections
2) Beneficence: maximize benefit to research while minimizing risk to subjects
3) Justice: one group of people shouldn't assume risks for the benefit of another
(equality and diversity of participants)
✔✔In what order were historical declarations for human subjects protection released? -
✔✔Nuremberg Code > Declaration of Helsinki > Belmont Report
✔✔At what reading level should ICFs be written? - ✔✔6th-8th grade
✔✔What FDA guideline lists the basic elements of informed consent? - ✔✔21 CFR 50
(50.25)
✔✔What are the additional elements of informed consent per FDA guidelines? (7) -
✔✔1) Statement that treatment may involve unforseeable risks
2) Circumstances in which subject participation may be terminated
3) Additional costs to subject
4) Consequences of subject's decision to withdraw
5) Statement that new findings will be provided to subject
6) # of subjects in study
7) clinicaltrials.gov statement (as applicable)
✔✔Who ultimately approves an ICF? - ✔✔IRB - sponsor can provide sample form
✔✔Describe the 2 most important points to consider when consenting patients (per 21
CFR 50) - ✔✔1) No person can participate without their or LAR consent (50.20)
2) Documentation of informed consent is required (50.27)
,✔✔What are the 4 components of the consent process using a short form? - ✔✔1)
Short form consent document stating all elements of ICF have been presented orally to
pt/LAR
2) Oral presentation of required elements
3) IRB-approved summary of what is said
4) Witness present during presentation
✔✔How do you document short form consent? - ✔✔1) Subject/LAR signs short form
consent
2) Witness signs short form consent and summary
3) Person obtaining consent signs summary
- Copy of short form consent and summary are given to subject/LAR
✔✔How do you document long form consent? - ✔✔Subject/LAR signs long form
consent
✔✔Do you keep informed consent records for patients who withdraw during study? -
✔✔Yes
✔✔CRA should monitor what elements of consent process? (5) - ✔✔1) Subject signed
most recent version of form
2) Subject signature and name are both present
3) Subject dated themselves and date is correct
4) Errors were corrected adequately
5) All pages of ICF are present
✔✔What is Source Data Verification? (SDV) - ✔✔CRF or other data collection
instruments are compared to original source of information to confirm data accuracy
✔✔What is Source Data Review (SDR) - ✔✔Review of source documentation to check
quality, and review and ensure protocol compliance
✔✔What is the definition of an adverse event (AE)? - ✔✔Sign, symptom, illness or
untoward experience that develops or worsens during a study, regardless of relation to
study treatment
✔✔How are AEs documented? - ✔✔- In AE CRF for sponsor (or other study collection
mechanism)
- In medical record
✔✔What 3 components of AE documentation should CRAs monitor? - ✔✔1) Ensure
AEs are recorded in study files and medical record
2) Make sure protocol procedures were followed
, 3) Check that responsible person assessed AE for seriousness, causality and
expectedness
✔✔What is the definition of a serious adverse event (SAE)? (5 possibilities) - ✔✔Any
untoward occurrence that results in:
1) Death
2) Life threatening
3) Requires hospitalization or prolongation of hospitalization
4) Results in significant disability
5) Results in congenital abnormality/birth defect
✔✔What FDA regulations govern SAE reporting? - ✔✔21 CFR 312
✔✔What is the medical device equivalent of an SAE? - ✔✔Unanticipated Adverse
Device Effect (UADE)
✔✔What is the definition of a UADE? - ✔✔- Any serious adverse effect on health/safety,
or any life-threatening problem or death associated with a device (if the effect was not
already identified in a pre-market application)
- Any other unanticipated serious problem associated with device as related to welfare
of subjects
✔✔What FDA regulations govern UADE reporting? - ✔✔21 CFR 812 (.15 and .3)
✔✔What regulations govern research with pregnant women and fetuses? - ✔✔45 CFR
46 Subpart B
✔✔What requirements must be met to conduct research with pregnant women/fetuses?
- ✔✔1) With preclinical and clinical data on non-pregnant women assessing risk to
pregnant women
2) Risk to fetus may result in direct benefit for woman or fetus, or risk is not greater than
minimal + knowledge can't be obtained any other way
3) Risk is least possible
4) Consent obtained
5) Research benefitting fetus only requires mom+dad consent
6) Individuals providing consent understand impact on neonate
7) Assent + permission for pregnant children required
8) No inducements offered to terminate pregnancy
9) Researchers have no part in decisions to terminate pregnancy
10) Researchers have no part in determining viability of neonate
✔✔When is father's consent not required for research involving neonates? - ✔✔- When
there is prospect of benefit to mom
- When dad unavailable, incompetent or temporarily incapacitated
- Rape/incest
SOLUTIONS RATED A+
✔✔Who developed the Declaration of Helsinki? - ✔✔World Medical Association (WMA)
✔✔What is the Declaration of Helsinki? - ✔✔Document that laid out general principles
physicians should follow to conduct research with humans, based on Nuremberg Code.
First effort of medical community to regulate itself
✔✔When was the Belmont Report released? - ✔✔1979
✔✔Who created the Belmont Report? - ✔✔National Commission for the Protection of
Human Subjects of Biomedical and Behavioral Research (at direction of National
Research Act 1974)
✔✔What are the 3 principles in the Belmont Report? - ✔✔1) Respect for Persons:
informed consent required and individuals with diminished autonomy get special
protections
2) Beneficence: maximize benefit to research while minimizing risk to subjects
3) Justice: one group of people shouldn't assume risks for the benefit of another
(equality and diversity of participants)
✔✔In what order were historical declarations for human subjects protection released? -
✔✔Nuremberg Code > Declaration of Helsinki > Belmont Report
✔✔At what reading level should ICFs be written? - ✔✔6th-8th grade
✔✔What FDA guideline lists the basic elements of informed consent? - ✔✔21 CFR 50
(50.25)
✔✔What are the additional elements of informed consent per FDA guidelines? (7) -
✔✔1) Statement that treatment may involve unforseeable risks
2) Circumstances in which subject participation may be terminated
3) Additional costs to subject
4) Consequences of subject's decision to withdraw
5) Statement that new findings will be provided to subject
6) # of subjects in study
7) clinicaltrials.gov statement (as applicable)
✔✔Who ultimately approves an ICF? - ✔✔IRB - sponsor can provide sample form
✔✔Describe the 2 most important points to consider when consenting patients (per 21
CFR 50) - ✔✔1) No person can participate without their or LAR consent (50.20)
2) Documentation of informed consent is required (50.27)
,✔✔What are the 4 components of the consent process using a short form? - ✔✔1)
Short form consent document stating all elements of ICF have been presented orally to
pt/LAR
2) Oral presentation of required elements
3) IRB-approved summary of what is said
4) Witness present during presentation
✔✔How do you document short form consent? - ✔✔1) Subject/LAR signs short form
consent
2) Witness signs short form consent and summary
3) Person obtaining consent signs summary
- Copy of short form consent and summary are given to subject/LAR
✔✔How do you document long form consent? - ✔✔Subject/LAR signs long form
consent
✔✔Do you keep informed consent records for patients who withdraw during study? -
✔✔Yes
✔✔CRA should monitor what elements of consent process? (5) - ✔✔1) Subject signed
most recent version of form
2) Subject signature and name are both present
3) Subject dated themselves and date is correct
4) Errors were corrected adequately
5) All pages of ICF are present
✔✔What is Source Data Verification? (SDV) - ✔✔CRF or other data collection
instruments are compared to original source of information to confirm data accuracy
✔✔What is Source Data Review (SDR) - ✔✔Review of source documentation to check
quality, and review and ensure protocol compliance
✔✔What is the definition of an adverse event (AE)? - ✔✔Sign, symptom, illness or
untoward experience that develops or worsens during a study, regardless of relation to
study treatment
✔✔How are AEs documented? - ✔✔- In AE CRF for sponsor (or other study collection
mechanism)
- In medical record
✔✔What 3 components of AE documentation should CRAs monitor? - ✔✔1) Ensure
AEs are recorded in study files and medical record
2) Make sure protocol procedures were followed
, 3) Check that responsible person assessed AE for seriousness, causality and
expectedness
✔✔What is the definition of a serious adverse event (SAE)? (5 possibilities) - ✔✔Any
untoward occurrence that results in:
1) Death
2) Life threatening
3) Requires hospitalization or prolongation of hospitalization
4) Results in significant disability
5) Results in congenital abnormality/birth defect
✔✔What FDA regulations govern SAE reporting? - ✔✔21 CFR 312
✔✔What is the medical device equivalent of an SAE? - ✔✔Unanticipated Adverse
Device Effect (UADE)
✔✔What is the definition of a UADE? - ✔✔- Any serious adverse effect on health/safety,
or any life-threatening problem or death associated with a device (if the effect was not
already identified in a pre-market application)
- Any other unanticipated serious problem associated with device as related to welfare
of subjects
✔✔What FDA regulations govern UADE reporting? - ✔✔21 CFR 812 (.15 and .3)
✔✔What regulations govern research with pregnant women and fetuses? - ✔✔45 CFR
46 Subpart B
✔✔What requirements must be met to conduct research with pregnant women/fetuses?
- ✔✔1) With preclinical and clinical data on non-pregnant women assessing risk to
pregnant women
2) Risk to fetus may result in direct benefit for woman or fetus, or risk is not greater than
minimal + knowledge can't be obtained any other way
3) Risk is least possible
4) Consent obtained
5) Research benefitting fetus only requires mom+dad consent
6) Individuals providing consent understand impact on neonate
7) Assent + permission for pregnant children required
8) No inducements offered to terminate pregnancy
9) Researchers have no part in decisions to terminate pregnancy
10) Researchers have no part in determining viability of neonate
✔✔When is father's consent not required for research involving neonates? - ✔✔- When
there is prospect of benefit to mom
- When dad unavailable, incompetent or temporarily incapacitated
- Rape/incest
