CCRP EVALUATION EXAM QUESTIONS AND SOLUTIONS
RATED A+
✔✔1) All grounds related to holds in Phase 1 trials AND
2) The protocol is clearly deficient in design to meet the stated objects - ✔✔Grounds for
FDA Clinical Hold in Phase II/III 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 - ✔✔Types of Phase I Trials
✔✔1) Initial demonstration of efficacy in subjects with the condition under investigation
2) obtain short term safety - ✔✔Goals of Phase II Trials
✔✔1) Confirmation of short term efficacy and safety
2) Establish long term efficacy and safety
3) Assess overall therapeutic value - ✔✔Goals of Phase III trials
✔✔Phase III - ✔✔What phase of study usually has the largest number of subjects per
study?
✔✔Phase I - ✔✔What phase of study is usually single-center?
✔✔Phase II/III - ✔✔What phases of stuides are usually multicenter?
✔✔1) Address FDA requirements for additional information not in NDA
2) Continue to assess overall therapeutic value
3)Surveillance for less common adverse events - ✔✔Goals of Phase IV Trials
✔✔1976 - ✔✔What year was the Medical Device Amendment?
✔✔Medical Device Reporting - ✔✔21 CFR Part 803
✔✔Investigational Device Exemption - ✔✔21 CFR Part 812
✔✔Premarket Approval of Medical Devices - ✔✔21 CFR Part 814
✔✔Quality System Regulations - ✔✔21 CFR Part 820
✔✔Medical Device Classification Procedures - ✔✔21 CFR Part 860
✔✔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 - ✔✔Device definitions excludes what 2 type of products
✔✔1976, With Medical Device Amendments - ✔✔When was 510K Clearance
Established?
✔✔Clearance - ✔✔What is a 510k?
✔✔1) Required process of scientific review to ensure the reasonable safety and
effectiveness of medical devices
2) FDA approval required before the device can be legally marketed - ✔✔Pre-Market
Approval Requirements
✔✔Lowest Risk, 510K often not required - ✔✔How do you define Class I Devices?
✔✔Class I, II, III - ✔✔How are devices distinguished by risk?
✔✔Moderate risk, usually requires 510k, might require PMA - ✔✔How do you define a
device with Class II risk?
✔✔Highest risk, PMA required - ✔✔How do you define a device with Class III risk?
✔✔Elastic bandages, exam gloves, hand-held surgical instruments - ✔✔Examples of
Class I devices
✔✔1) Prohibition against adulterated or misbranded devices
2) Premarket notification 510k requirements
3) GMPs
4) Registration of manufacturing facilities
5) listing of device types - ✔✔What are the general controls that provide reasonable
assurance of safety for a device?
✔✔Class I - ✔✔What type of device is sufficiently assured by general device controls?
✔✔1) Special labeling requirements
2) mandatory performance standards
3) post-market surveilance - ✔✔In addition to general controls, Class II devices are also
subject to these types of special controls
✔✔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 - ✔✔Class III Devices
Descriptions
RATED A+
✔✔1) All grounds related to holds in Phase 1 trials AND
2) The protocol is clearly deficient in design to meet the stated objects - ✔✔Grounds for
FDA Clinical Hold in Phase II/III 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 - ✔✔Types of Phase I Trials
✔✔1) Initial demonstration of efficacy in subjects with the condition under investigation
2) obtain short term safety - ✔✔Goals of Phase II Trials
✔✔1) Confirmation of short term efficacy and safety
2) Establish long term efficacy and safety
3) Assess overall therapeutic value - ✔✔Goals of Phase III trials
✔✔Phase III - ✔✔What phase of study usually has the largest number of subjects per
study?
✔✔Phase I - ✔✔What phase of study is usually single-center?
✔✔Phase II/III - ✔✔What phases of stuides are usually multicenter?
✔✔1) Address FDA requirements for additional information not in NDA
2) Continue to assess overall therapeutic value
3)Surveillance for less common adverse events - ✔✔Goals of Phase IV Trials
✔✔1976 - ✔✔What year was the Medical Device Amendment?
✔✔Medical Device Reporting - ✔✔21 CFR Part 803
✔✔Investigational Device Exemption - ✔✔21 CFR Part 812
✔✔Premarket Approval of Medical Devices - ✔✔21 CFR Part 814
✔✔Quality System Regulations - ✔✔21 CFR Part 820
✔✔Medical Device Classification Procedures - ✔✔21 CFR Part 860
✔✔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 - ✔✔Device definitions excludes what 2 type of products
✔✔1976, With Medical Device Amendments - ✔✔When was 510K Clearance
Established?
✔✔Clearance - ✔✔What is a 510k?
✔✔1) Required process of scientific review to ensure the reasonable safety and
effectiveness of medical devices
2) FDA approval required before the device can be legally marketed - ✔✔Pre-Market
Approval Requirements
✔✔Lowest Risk, 510K often not required - ✔✔How do you define Class I Devices?
✔✔Class I, II, III - ✔✔How are devices distinguished by risk?
✔✔Moderate risk, usually requires 510k, might require PMA - ✔✔How do you define a
device with Class II risk?
✔✔Highest risk, PMA required - ✔✔How do you define a device with Class III risk?
✔✔Elastic bandages, exam gloves, hand-held surgical instruments - ✔✔Examples of
Class I devices
✔✔1) Prohibition against adulterated or misbranded devices
2) Premarket notification 510k requirements
3) GMPs
4) Registration of manufacturing facilities
5) listing of device types - ✔✔What are the general controls that provide reasonable
assurance of safety for a device?
✔✔Class I - ✔✔What type of device is sufficiently assured by general device controls?
✔✔1) Special labeling requirements
2) mandatory performance standards
3) post-market surveilance - ✔✔In addition to general controls, Class II devices are also
subject to these types of special controls
✔✔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 - ✔✔Class III Devices
Descriptions
