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SOCRA CCRP Exam ACTUAL EXAM QUESTIONS & Verified ANSWERS WITH RATIONALES 2024 GRADED A+
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SOCRA CCRP Exam ACTUAL EXAM QUESTIONS & Verified ANSWERS WITH RATIONALES 2024 GRADED A+
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SOCRA CCRP Exam ACTUAL EXAM QUESTIONS &Verified ANSWERS WITH RATIONALES 2024 |GRADED
A+
SOCRA CCRP Exam ACTUAL EXAM QUESTIONS &
Verified ANSWERS WITH RATIONALES 2024 |GRADED
A+
>$25,000 - ANSWhat is the $ reported amount for a financial disclosure for significant
payments?
>$50,000 - ANSWhat is the $ reported amount for a financial disclosure for equity
interest in a publicly traded company?
1) A Short form Consent document
2) An oral presentation of the required elements of informed consent
3)and IRB approved written summary of what is to be said to the participant or LAR
4)A witness must be present during the oral presentation - ANSFour components
needed for Short Form Consent
1) Achieve their primary intended purpose through chemical action within the body
2) Are dependent upon being metabolized for the primary achievement of the primary
intended purpose - ANSDevice definitions excludes what 2 type of products
1) Address FDA requirements for additional information not in NDA
2) Continue to assess overall therapeutic value
3)Surveillance for less common adverse events - ANSGoals of Phase IV Trials
1) All grounds related to holds in Phase 1 trials AND
2) The protocol is clearly deficient in design to meet the stated objects - ANSGrounds
for FDA Clinical Hold in Phase II/III Trials
1) Any serious adverse effect on health or safety or any life-threatening problem or
death caused by, or associated with a device
2)if that effect, problem, or death was not previously identified in nature, severity, or
degree of incidence in the investigational plan or application
2) any other unanticipated serious problem associated with a device that relates to the
rights, safety, or welfare of subjects - ANSDefinition of Unanticipated adverse device
effect
1) Approval
2) Modifications needed
,SOCRA CCRP Exam ACTUAL EXAM QUESTIONS &
Verified ANSWERS WITH RATIONALES 2024 |GRADED
A+
3) Disapproval - ANSWhat are the 3 outcomes of IRB review?
1) Are usually those that support or sustain human life
2) are of substantial importance in preventing the impairment of human health
3)Present a potential, unreasonable risk of illness or injury - ANSClass III Devices
Descriptions
1) Cardiovascular
2)Respiratory
3)CNS - ANSThree vital organ considered highest priority
1) Compensation affected by study outcome or in the form of equity interest in sponsor
or compensation tied to sales
2)Significant equity interest in sponsor
3) Proprietary interest in tested product
4) Significant payments of other sorts to investigator or institution supporting activities of
investigator - ANSWhat are 4 types of financial disclosures?
1) Confirmation of short term efficacy and safety
2) Establish long term efficacy and safety
3) Assess overall therapeutic value - ANSGoals of Phase III trials
1) Fairness, potential participants should be treated equally
2)Benefit of research not restricted to those who can afford it
3)Research should not involve persons from groups not likely to benefit from application
of the research - ANSWhat does "Justice" entail?
1) Fatal
2)Life-threatening
3)requires or prolongs inpatient hospitalization
3) results in persistent or significant injury
4)A congential anomaly - ANSIn order to be considered a SAE, the event needs to meet
one of the following criteria:
1) In an Implant
2)is used in supporting or sustaining life
3)is of substantial importance in diagnosing, curing, mitigating or treating disease or
other prevents impairment of human health
4)otherwise presents a potential for serious risk to the health, safety, or welfare of a
subject - ANSA Significant Risk (SR) Device Study is defined as:
, SOCRA CCRP Exam ACTUAL EXAM QUESTIONS &
Verified ANSWERS WITH RATIONALES 2024 |GRADED
A+
1) Initial demonstration of efficacy in subjects with the condition under investigation
2) obtain short term safety - ANSGoals of Phase II Trials
1) Initial Safety, dose escalation studies to determine MTD
2) PK and PD property, might be cross over design
3) Absorption, distribution, metabolism and excretion studies
4) Efficacy assessment, if possible - ANSTypes of Phase I Trials
1) Inventory of product received by site, and date
2) Dispensing and return information for each subject
3)Specific protocol information like batch numbers, expiration dates, serial numbers,
unique codes assigned to trial subjects - ANSDrug accountability records should
contain:
1) Manufacturing, packaging, labeling and coding of the investigational drug
2) Providing the investigational product only to investigators participating in an
investigation
3)Maintain drug and device accountability records from manufacturing through use,
return and destruction - ANSWhat are SPONSOR responsibilities with regard to IP?
1) Medical Monitor
2) Data Safety Monitoring Boards
3) On-site monitoring - ANSWhat are three types of monitoring the sponsor is
responsible for?
1) Notifying the FDA
2) Stopping all studies and notifying the investigators
3)All drug returned to the sponsor or destroyed as directed by sponsor
4)If withdrawn due to safety reasons, the sponsor must notify the investigators and the
IRBs of those reasons - ANSSponsors have the right with withdraw an IND at anytime,
without prejudice by completing the following: (21 CFR Part 312)
1) Novelty of drug
2)Extent the drug has been studied previously
3) Known of suspected risks
4) Phase of development - ANSIND information depends on the amount of information
available, these 4 things are: (21 CFR Part 312)
1) PK and toxicokinetic
2) Single dose toxicity
3) Repeated dose toxicity
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