>$25, 000 - ANS WER- What i s t he $ r eport ed a mount f or a fi nanci al di scl osur e f or
si gnifi cant pay ment s?
. >$50, 000 - ANS WER- What i s t he $ r eport ed a mount f or a fi nanci al di scl osur e f or equit y
i nt er est i n a publi cl y tr aded co mpany?
. 1) A Short f or m Consent docu ment
2) An or al pr esent ati on of t he r equi r ed el ement s of i nf or med consent
3) and I RB appr oved writt en su mmar y of what i s t o be sai d t o t he parti ci pant or LAR
4) A wit ness must be present duri ng t he or al pr esent ati on - ANS WER- Four co mponent s
needed f or Short For m Consent
. 1) Achi eve t hei r pri mary i nt ended pur pose t hr ough che mi cal acti on wi t hi n t he body
2) Ar e dependent upon bei ng met aboli zed f or t he pri mar y achi eve ment of t he pri mar y
i nt ended pur pose - ANS WER- Devi ce defi niti ons excl udes what 2 t ype of pr oduct s
. 1) Addr ess FDA r equi re ment s f or addi ti onal inf or mati on not i n NDA
2) Conti nue t o assess over all t her apeuti c val ue
3) Sur veill ance f or l ess co mmon adver se event s - ANS WER- Goal s of Phase I V Tri al s
. 1) All gr ounds r el at ed t o hol ds i n Phase 1 tri al s AND
2) The pr ot ocol i s cl earl y defi ci ent i n desi gn t o meet t he st at ed obj ect s - ANS WER-
Gr ounds f or FDA Cli ni cal Hol d i n Phase II/III Tri al s
. 1) Any seri ous adver se eff ect on heal t h or saf et y or any lif e-t hr eat eni ng pr obl em or
deat h caused by, or associ at ed wit h a devi ce
2)if t hat eff ect, pr obl em, or deat h was not pr evi ousl y i dentifi ed i n nat ur e, severit y, or
degr ee of i nci dence i n t he i nvesti gati onal pl an or appli cati on
2) any ot her unanti ci pat ed seri ous pr obl em associ at ed wit h a devi ce t hat r el at es t o t he
ri ght s, saf et y, or wel f are of subj ect s - ANS WER- Defi niti on of Unanti cipat ed adver se
devi ce eff ect
. 1) Appr oval
2) Modi fi cati ons needed
3) Di sappr oval - ANSWER- What ar e t he 3 out co mes of I RB r evi ew?
. 1) Ar e usuall y t hose t hat support or sust ai n hu man lif e
2) ar e of subst anti al i mport ance i n pr eventi ng t he i mpai r ment of hu man heal t h
3) Pr esent a pot enti al, unr easonabl e ri sk of illness or i nj ur y - ANS WER- Cl ass III Devi ces
Descri pti ons
,. 1) Car di ovascul ar
2) Respi r at or y
3) CNS - ANS WER- Thr ee vit al or gan consi dered hi ghest pri orit y
. 1) Co mpensati on aff ect ed by st udy out co me or i n t he f or m of equi t y i nt er est i n sponsor
or co mpensati on ti ed to sal es
2) Si gnifi cant equi t y i nter est i n sponsor
3) Pr opri et ar y i nt er est in t est ed pr oduct
4) Si gnifi cant pay ment s of ot her sort s t o i nvesti gat or or i nstit uti on supporti ng acti viti es of
i nvesti gat or - ANS WER- What ar e 4 t ypes of fi nanci al di scl osur es?
. 1) Confir mati on of short t er m effi cacy and saf et y
2) Est abli sh l ong t er m effi cacy and saf et y
3) Assess over all t her apeuti c val ue - ANS WER- Goal s of Phase III trial s
. 1) Fai r ness, pot enti al parti ci pant s shoul d be treat ed equall y
2) Benefit of r esear ch not r estri ct ed t o t hose who can aff or d it
3) Resear ch shoul d not i nvol ve per sons fr om gr oups not li kel y t o benefit from appli cati on
of t he r esear ch - ANSWER- What does "Justice" ent ail ?
. 1) Fat al
2) Lif e-t hr eat eni ng
3)r equi r es or pr ol ongs i npati ent hospi t ali zati on
3) r esult s i n per si st ent or si gnifi cant i nj ur y
4) A congenti al ano mal y - ANS WER-I n or der to be consi der ed a SAE, t he event needs
t o meet one of t he f oll owi ng crit eri a:
. 1) I n an I mpl ant
2)i s used i n supporti ng or sust ai ni ng lif e
3)i s of subst anti al i mport ance i n di agnosi ng, curi ng, miti gati ng or tr eati ng di sease or
ot her pr event s i mpai r ment of hu man heal t h
4) ot her wi se pr esent s a pot enti al f or seri ous risk t o t he heal t h, saf et y, or wel f ar e of a
subj ect - ANS WER- A Si gni fi cant Ri sk ( SR) Devi ce St udy i s defi ned as:
. 1) I niti al de monstr ati on of effi cacy i n subj ect s wit h t he condi ti on under i nvesti gati on
2) obt ai n short t er m saf et y - ANS WER- Goal s of Phase II Tri al s
. 1) I niti al Saf et y, dose escal ati on st udi es t o det er mi ne MTD
2) PK and PD pr opert y, might be cr oss over desi gn
3) Absor pti on, di stri bution, met aboli s m and excr eti on st udi es
4) Effi cacy assess ment, if possi bl e - ANS WER- Types of Phase I Trial s
. 1) I nvent or y of pr oduct recei ved by sit e, and dat e
2) Di spensi ng and r et ur n i nf or mati on f or each subj ect
, 3) Speci fi c pr ot ocol i nf or mati on li ke bat ch nu mber s, expi r ati on dat es, seri al nu mber s,
uni que codes assi gned t o tri al subj ect s - ANSWER- Dr ug account abilit y r ecor ds shoul d
cont ai n:
. 1) Manuf act uri ng, packagi ng, l abeli ng and codi ng of t he i nvesti gati onal dr ug
2) Pr ovi di ng t he i nvestigati onal pr oduct onl y to i nvesti gat or s parti ci pati ng i n an
i nvesti gati on
3) Mai nt ai n dr ug and devi ce account abilit y r ecor ds fr om manuf act uring t hr ough use,
r et ur n and destr ucti on - ANS WER- What ar e SPONSOR r esponsi biliti es wit h r egar d t o
I P?
. 1) Medi cal Moni t or
2) Dat a Saf et y Moni t oring Boar ds
3) On- sit e moni t ori ng - ANS WER- What ar e t hree t ypes of moni t ori ng t he sponsor i s
r esponsi bl e f or ?
. 1) Notif yi ng t he FDA
2) St oppi ng all st udi es and notif yi ng t he i nvest i gat or s
3) All dr ug r et ur ned t o the sponsor or destr oyed as di r ect ed by sponsor
4)If wit hdr awn due t o saf et y r easons, t he sponsor must notif y t he i nvesti gat or s and t he
I RBs of t hose r easons - ANS WER- Sponsor s have t he ri ght wit h wit hdr aw an I ND at
anyti me, wit hout pr ej udi ce by co mpl eti ng t he f oll owi ng: ( 21 CFR Par t 312)
. 1) Novel t y of dr ug
2) Ext ent t he dr ug has been st udi ed pr evi ousl y
3) Known of suspect ed ri sks
4) Phase of devel op ment - ANS WER-I ND i nfor mati on depends on the amount of
i nf or mati on avail abl e, these 4 t hi ngs ar e: ( 21 CFR Part 312)
. 1) PK and t oxi coki netic
2) Si ngl e dose t oxi cit y
3) Repeat ed dose t oxi cit y
4) Local t ol er ance
5) Genot oxi cit y
6) Car ci nogeni cit y
7) Repr oducti on t oxi city
8) Suppl ement al st udi es if needed - ANS WER- Types of Non- Cli ni cal St udi es ( Ani mal
Tri al s)
. 1) Pri soner s
2) Pr egnant wo men, chil dr en
3) Handi capped
4) ment all y di sabl ed
5) econo mi call y or educati onall y di sadvant aged - ANS WER- What popul ati ons ar e mor e
li kel y t o be a vul ner abl e subj ect ?
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