IND Studies Exam Questions With Correct Answers
// // // // // //
Click /
/the /
/arrows /
/below /
/to //begin. //- //CORRECT //ANSWERS(S)✔✔Good //Clinical //Practices //Made //Easy //Flash //Cards
Copyright //2002, //The //RAN //Institute, //Inc.
True.
21 /
/CFR /
/312.2 //- /
/CORRECT /
/ANSWERS(S)✔✔IND /
/regulations /
/typically /
/do /
/not /
/apply /
/to /
/investigations /
/with /
/lawfully /
/marketed /
/drugs /
/which /
/are /
/being /
/studied /
/for /
,/purposes /
/other /
/than /
/supporting //
a //chance //in //labeling //or //a //change //in //advertising, //so //long //as //the //study //complies //with //IRB
//and /
/consent /
/regulations //and //does //not //significantly //increase //risks //or //decrease //acceptability //of //risks.
True //or //False?
True.
21 /
/CFR /
/312.2 //- /
/CORRECT /
/ANSWERS(S)✔✔Some /
/clinical /
/investigations /
/involving /
/an /
/in /
/vitro /
/diagnostic /
/biologic /
/product /
/may /
/be /
/exempt /
/from /
/the /
/IND /
/regulations /
/if /
,/it /
/is /
/used /
/only /
/to /
/confirm //
a //diagnosis //made //by //another //medically //established //diagnostic //product //or //procedure.
True //or //False?
True.
21 /
/CFR /
/312.2 //- /
/CORRECT /
/ANSWERS(S)✔✔Clinical /
/research //on //blood //grouping //serum, //reagent //red //blood //cells //and //anti-
human //globulin //are //generally //exempt //from //the //FDA's //IND //regulation.
True //or //False?
True.
21 /
/CFR /
/312.2 //- /
/CORRECT /
/ANSWERS(S)✔✔Clinical /
/investigations /
/involving /
/placebos /
, /may /
/be /
/exempt /
/from /
/the /
/IND /
/regulations /
/if //the //investigation //does //not //otherwise //require //the //submission //of //an //IND //application.
True //or //False?
True.
21 /
/CFR /
/312.2 //- /
/CORRECT /
/ANSWERS(S)✔✔Use /
/of //
a/
/marketed /
/drug /
/or /
/biologic /
/product /
/for /
/an /
/unlabeled //indication //in //the //practice //of //medicine //is //not //subject //to //the //IND //regulations.
True //or //False?
True.
// // // // // //
Click /
/the /
/arrows /
/below /
/to //begin. //- //CORRECT //ANSWERS(S)✔✔Good //Clinical //Practices //Made //Easy //Flash //Cards
Copyright //2002, //The //RAN //Institute, //Inc.
True.
21 /
/CFR /
/312.2 //- /
/CORRECT /
/ANSWERS(S)✔✔IND /
/regulations /
/typically /
/do /
/not /
/apply /
/to /
/investigations /
/with /
/lawfully /
/marketed /
/drugs /
/which /
/are /
/being /
/studied /
/for /
,/purposes /
/other /
/than /
/supporting //
a //chance //in //labeling //or //a //change //in //advertising, //so //long //as //the //study //complies //with //IRB
//and /
/consent /
/regulations //and //does //not //significantly //increase //risks //or //decrease //acceptability //of //risks.
True //or //False?
True.
21 /
/CFR /
/312.2 //- /
/CORRECT /
/ANSWERS(S)✔✔Some /
/clinical /
/investigations /
/involving /
/an /
/in /
/vitro /
/diagnostic /
/biologic /
/product /
/may /
/be /
/exempt /
/from /
/the /
/IND /
/regulations /
/if /
,/it /
/is /
/used /
/only /
/to /
/confirm //
a //diagnosis //made //by //another //medically //established //diagnostic //product //or //procedure.
True //or //False?
True.
21 /
/CFR /
/312.2 //- /
/CORRECT /
/ANSWERS(S)✔✔Clinical /
/research //on //blood //grouping //serum, //reagent //red //blood //cells //and //anti-
human //globulin //are //generally //exempt //from //the //FDA's //IND //regulation.
True //or //False?
True.
21 /
/CFR /
/312.2 //- /
/CORRECT /
/ANSWERS(S)✔✔Clinical /
/investigations /
/involving /
/placebos /
, /may /
/be /
/exempt /
/from /
/the /
/IND /
/regulations /
/if //the //investigation //does //not //otherwise //require //the //submission //of //an //IND //application.
True //or //False?
True.
21 /
/CFR /
/312.2 //- /
/CORRECT /
/ANSWERS(S)✔✔Use /
/of //
a/
/marketed /
/drug /
/or /
/biologic /
/product /
/for /
/an /
/unlabeled //indication //in //the //practice //of //medicine //is //not //subject //to //the //IND //regulations.
True //or //False?
True.
