CCRC Exam Questions With Correct Answers
Protocols |- |CORRECT |ANSWER✔✔-1) |General |Information
2) |Background |info
3) |Trial |objectives |and |purpose
4) |Trial |design
5) |Selection |and |withdrawal |of |subjects
6) |Treatment |of |Subjects
7) |Assessment |of |Efficacy
8) |Assessment |of |Safety
9) |Statistics
10) |Source |Data/Docs
11) |Quality |control/assurance
12) |ethics
13) |data |handling |and |record |keeping
14) |financing |and |insurance
15) |publication |policy
16) |supplements
Phase |1 |- |CORRECT |ANSWER✔✔--intro |of |new |drug/investigational |product |into |humans
-healthy |population |(exception: |oncology |and |HIV)
-design: |single |dose, |open |label, |max |tolerated |dose
-PR, |PD, |BA, |BE, |dosing, |metabolis
*focus |is |SAFETY
, Phase |2 |- |CORRECT |ANSWER✔✔--Intro |to |subjects |with |disease
-design: |compare |with |placebo |(exception: |cancer |and |antibiotics), |double |blind
*AIM: |define |dose
| evaluate |short |term |safety |and |efficacy |in |patients |with |disease
| dose |response, |dose |tolerance, |AE's
Phase |3 |- |CORRECT |ANSWER✔✔--Evaluate |overall |benefit |to |risk |in |large |group |of |patients
-broader |eligibility, |2 |or |3 |tx |groups. |controlled |or |uncontrolled
*AIM: |establish |long-term |safety |and |efficacy |with |selected |doses |in |broad |subject |sample
dosing |invervals, |drug-drug |interactions, |risk-benefit
pivotal |to |FDA |approval
Phase |4 |- |Post |Marketing |- |CORRECT |ANSWER✔✔-Continue |to |collect |long-term |safety |data |
and |gather |optimal |use |info
Conduct |AFTER |regulatory |approves |IND
Open |label
IND |- |Investigational |New |Drug |- |CORRECT |ANSWER✔✔-Application |- |FDA |form |1571
Permit |to |perform |research |with |a |specific |investigational |new |drug |on |humans |for |the |first |
time |in |the |US
Includes: |background |info, |rationale, |sponsors |plan
Continually |amended |by |sponsors |to |reflect |protocol |changes |and |new |info
Effective |30 |days |after |receipt |by |FDA
Updated |annually |by |sponsors
Protocols |- |CORRECT |ANSWER✔✔-1) |General |Information
2) |Background |info
3) |Trial |objectives |and |purpose
4) |Trial |design
5) |Selection |and |withdrawal |of |subjects
6) |Treatment |of |Subjects
7) |Assessment |of |Efficacy
8) |Assessment |of |Safety
9) |Statistics
10) |Source |Data/Docs
11) |Quality |control/assurance
12) |ethics
13) |data |handling |and |record |keeping
14) |financing |and |insurance
15) |publication |policy
16) |supplements
Phase |1 |- |CORRECT |ANSWER✔✔--intro |of |new |drug/investigational |product |into |humans
-healthy |population |(exception: |oncology |and |HIV)
-design: |single |dose, |open |label, |max |tolerated |dose
-PR, |PD, |BA, |BE, |dosing, |metabolis
*focus |is |SAFETY
, Phase |2 |- |CORRECT |ANSWER✔✔--Intro |to |subjects |with |disease
-design: |compare |with |placebo |(exception: |cancer |and |antibiotics), |double |blind
*AIM: |define |dose
| evaluate |short |term |safety |and |efficacy |in |patients |with |disease
| dose |response, |dose |tolerance, |AE's
Phase |3 |- |CORRECT |ANSWER✔✔--Evaluate |overall |benefit |to |risk |in |large |group |of |patients
-broader |eligibility, |2 |or |3 |tx |groups. |controlled |or |uncontrolled
*AIM: |establish |long-term |safety |and |efficacy |with |selected |doses |in |broad |subject |sample
dosing |invervals, |drug-drug |interactions, |risk-benefit
pivotal |to |FDA |approval
Phase |4 |- |Post |Marketing |- |CORRECT |ANSWER✔✔-Continue |to |collect |long-term |safety |data |
and |gather |optimal |use |info
Conduct |AFTER |regulatory |approves |IND
Open |label
IND |- |Investigational |New |Drug |- |CORRECT |ANSWER✔✔-Application |- |FDA |form |1571
Permit |to |perform |research |with |a |specific |investigational |new |drug |on |humans |for |the |first |
time |in |the |US
Includes: |background |info, |rationale, |sponsors |plan
Continually |amended |by |sponsors |to |reflect |protocol |changes |and |new |info
Effective |30 |days |after |receipt |by |FDA
Updated |annually |by |sponsors
