CCRC Exam Questions With Correct
Answers
Protocols /- /correct /answer(s) /✔✔ /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(s) /✔✔ /-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(s) /✔✔ /-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(s) /✔✔ /-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(s) /✔✔ /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(s) /✔✔ /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
Answers
Protocols /- /correct /answer(s) /✔✔ /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(s) /✔✔ /-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(s) /✔✔ /-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(s) /✔✔ /-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(s) /✔✔ /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(s) /✔✔ /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
