oo Dru Adminlst Adminlstratlo ratlonnM in in ne ne ap ap ol ol i D i t riri c f fifi c Cent Centra ra Regi Region on 212 Third Third Avenue South Minneapolis, 55401 Tele Teleph phon one: e: (612 (612 334334-41 4100 00 (612 334-4 334-4134 134 F A X : (612
Clini Clinical cal Invest Investiga igator tor 24 iver iversi si enue enue F282 F282-2 -2 estest-
)f
Sincerely,
Ei.1.~4 Director inne inneap apol olis is
CCL/cel nclo nclosu sure re
EI
1/31/3-6, 6,11 11,1 ,19, 9,21 21,2 ,26/ 6/05 05
Dist Distri rict ct
io St ph
Olso Olson, n, li
FEI:
3004927371
EI Star Start: t:
01/03/2005
EIEnd:
0112612005
-
HI TORY TORY OF BUSI BUSINE NE dI DS Comp Compla lain in
conduc conducted ted this clin clinic ic inve invest stig igat ator or insp inspec ecti tion on nd data data udit udit pe Fo Caus Caus assi assign gnme ment nt ro th Cent Center er or ru Ev lu tion tion nd Rese Rese rc (CDE (CDERI RIHF HFDD-46 46), ), at 12/14/04 to foll follow ow-u -u on Divi Divisi sion on of Scie Scient ntif ific ic nv stig stig tion tion Comp Compla lain in 00 (Att (Attac achm hmen en an 2) This This is th fi st DA insp insp ctio ctio
this this lini lini al inve invest stig ig to
Th st dy assi assign gn or audi audi is titl titl Effi Effica ca nd Tole Tolera rabi bili lity ty of Ol nzap nzapin in ueti ueti pi an Risp Risp id ne in th Trea Treatm tmen en of irst irst piso pisode de sych sychos osis is Rand Random omiz ized ed Doub Double le Blin Blin 52 We Comp Comp riso rison" n" ka CA tudy tudy", ", pr to ol numb number er S077IL/OlI4, IND 32,1 32,132 32 spon sponso so ed by Astr AstraZ aZen enec ec (Att (Attac achm hmen en #3). #3).
in dd esse esse us
ig Co la thro throug ug me ic
Comp Compli lian an
rogr rogr
io revi review ew
CDER CDER
7348 7348.8 .811 11 or this this insp insp tion tion
10f21
nd repo repo t.
this this
MD
__ _---_.
_
FAX:
3004927371
Start:
01/03/2005
End:
01/26/2005
_ .
F282 F282-2 -2 Phone:
FEI:
estest-
612/273-9763 612/273-9779
above) E-mail:
[email protected] Date Date
of insp inspec ecti tion on
1 13 13 /2 /2 00 00 5 1 14 14 /2 /2 00 00 5 1 15 1 5 /2 /2 00 00 5 1 /2 /2 1 2 00 00 5 1 12 1 2 61 61 20 20 0
Mats Matson on
HISTORY
1 /6 /6 /2 /2 00 00 5
1 11 1 1 1 2 00 00 5
1 /1 /1 9 2 00 00 5
Inve Invest stig igat ator or
BUSINESS
(UMN)
an 1.
UM
He lt
12
"Station
12
as
4/1/03.
-Riverside hospital as described as
art"
in
is
of21
Esta Establ blis is
en
In pect pectio io
Re or
FEI:
Step Stephe he Olso Olson, n, MD Minn Minnea eapo poli lis, s, MN
5454 5454
3004927371
El Star Start: t:
01/0312005
EI En
01/26/2005
Dr Olso Olso is co pe sate sate thro throug ug both both Univ Univer ersi sity ty ofMN ofMN Ph sici sician an (UMP) as an inde indepe pend nden en lice licens nsed ed phys physic icia ian, n, an thro throug ug UM rese resear arch ch fund funds. s. TE VI This This insp inspec ecti ti
IN
wa unan unan ounc ounced ed
ID
LI
show showed ed up at th refe refere re ce ad ress ress show showed ed cred creden enti tial al
an
482
fo ex ai au comp compla lain in an that that it fu re en r. ques questi tion on aske aske an wa avai availa labl bl upon upon requ reques es thro throug ugho hout ut this this insp inspec ecti tion on
rm ro Profess Profession ional al Buildi Building ng
ed
rr ea (A rs Ave, Ave, Suit Suit #602, Mi neap neapol olis is MN 5545 55454) 4) whic whic is atta attach ched ed ra rt
rd As
r, ra
To ethe ether, r, Dr Olso Olso an Ms Kenn Kenney ey prov provid ided ed acce access ss to th stud stud reco record rds, s, in an outp outpat atie ie me ical ical reco record rds, s, an answ answer ered ed al ques questi tion on as ed Dr Olso Olso is th prin princi ci al in esti esti ator ator this this st dy He atte atte de th In esti esti ator ator's 's Meet Meet ng in Chap Chapel el Hill Hill NC 1/21-24/02. ri re pons ponsib ibil ilit itie ie fo this this st dy incl incl de co muni munica cati ti ns with with th spon sponso sor, r, onit onit r, an IRE; IRE; akin akin diag diagno nose ses; s; part partic icip ipat atin in in info inform rmed ed cons consen ent; t; dete determ rmin inin in subj subjec ec elig eligib ibil ilit ity; y; seei seeing ng subj subjec ects ts at each each visi visit, t, revi review ewin in eval evalua uati tion ons, s, an dete determ rmin inin in whet whethe he subj subjec ects ts shou should ld cont contin inue ue and, and, over overse seei eing ng stud stud staf staff. f. Dr Olso Olso 's co-i co-inv nves esti ti ator ator
Th
subj subjec ec ofDS ofDS
at ac
Comp Compla lain in
on this this st dy are: are:
#2
ch #13IDRM, the
006 on 11/29/03
12. 30f21
FEI:
3004927371
Start:
01/0312005 0112612005
-7
-7 MN 55108.
Minneapolis,
Rm
in 6/02 la
to pros prospe pect ctiv iv
th
subj subjec ects ts an
in
--
is
through through UMN
(P
of records:
as Exhibit
#4]
rm
ig
MD, Me ta
Reta Retard rdat atio io
MN
r,
in
(Att (Attac achm hm nt
t.
#2)
ta
to
tr
#JSD
40f21
U1v1N (Attachment
Esta Establ blis ishm hmen en teph teph
FEI:
Insp Insp tion tion Repo Repo
Olso Olson, n, MD
inne inne poli polis, s, MN 5545 5545
3004927371
EI Star Start: t:
01103/2005
EI nd
01/26/2005
~
vi
ttit ttit Case Case Mana Mana erlM erlM nt
heod heod re Da
side sidenc nc /g ou
He lt Soci Soci
om st ff th
rker rker
akot akot
ount ount
tu ll inte intera ra te with with DR
Buse Buse psyc psycho hoth ther erap apis ist, t, Da Trea Treatm tmen en Prog Progra ram, m, FUMC FUMC-R -R
Thou Though gh th ir di ecto ecto lati lati e. Cons Cons nt
ot ursu ursu
this this ti
pe
onsu onsult lt tion tion with with th
This This ompl ompl in in olve olve th deat deat /sui /sui id of RM
ubje ubje
#1 in th
ssig ssignm nmen en
ef renc renc
onta onta t.
tudy tudy DR
5/8/04
ches chest" t" with with ontr ontrib ib ting ting ondi onditi tion on of hist histor or of ment ment illn illn ss mann mann de th "s icid icide" e" is eath eath Cert Certif ific ic te utop utopsy sy Re ort, ort, nd ious ious dv se vent vent epor epor ar tt he xhib xhibit it
diso disord rder er
or schi schizo zoaf affe fect ctiv iv
diso disord rder er 11/12/03
th
DR
dmis dmissi sion on 1.
ot
to
tran transf sf
from from Regi Region on
ospi ospita tal, l,
t.
ul MN
gran grandi dios os gita gitate te an havi havi sl robl robl ms it thro throug ugho hout ut is dmis dmissi sion on unti unti isch ischar arge ge on 12/8/03. Init Initia ia note note incl includ ud diff differ eren enti tial al diag diagno nose se of ossi ossibl bl mo isor isorde de nd bipo bipola la well well as sc iz ph ni he di fere ferent ntia ia is chiz chiz ph ni by th time time disc discha harg rg RM inpa inpati ti nt medi medi al re ords ords re tt ched ched xhib xhibit it 13 th foll follow owin in chro chrono nolo logy gy is prov provid ided ed fo refe refere renc nce. e. 11/12/03
pres pres te
in on dmis dmissi si
ft
MC
ia nose noses, s, Axis Axis I:
sy ho is no ot er is spec specif ifie ie
iz 11113/03
tten ttendi ding ng Admi Admiss ssio io Note Note [b lson lson iagn iagnos osis is xi I: sy hosi hosi NO Diff Differ eren enti tial al diag diagno nosi si incl includ udes es para parano noid id schi schizo zoph phre reni nia, a, schi schizo zoaf affe fect ctiv iv diso disord rder er an ti tart tart
ispe isperd rdal al
mg or psyc psycho hosi si 50f21
stab stabli lish shme me
Insp Inspec ecti ti
Re or
FEI:
Step Stephe he Olso Olson, n, MD Minn Minnea ea olis olis MN _
3004927371
EI Star Start: t: 45
01103/2005
nd
_
01/26/2005
-
In erna erna ed ci co ul otherwise normal.
TS
hyper hyperlip lipide idemia mia elevat elevated ed total total biliru bilirubin bin
nor na
11/14/03
xa iner iner's 's Stat Statem emen en in Supp Supp rt of Pe it on fo Co mi me Dr so ta es psyc psycho hosi si NOS: NOS: para parano noid id schi schizo zoph phre reni ni vs psyc psycho hoti ti mam~ys. psyc psycho hosi si du to medi medica ca cond condit itio io pe exam examin inat atio io 11/13/03. 11/15/03
Psyc Psycho hosi si
11117103
At en in
NO te ta es MR an thyr thyr
st dies dies norm normal al Diag Diagno nosi si
Psyc Psyc os
NO
PrePre-Pe Peti titi tion on Scre Screen enin in Prog Progra ra Repo Report rt reco recomm mmen ends ds comm commit itme ment nt du to "men "menta tall ll diagno nose se Psyc Psycho hosi si NOS, NOS, Mood Mood Diso Disord rder er NOS, NOS, IO Bipolar, IO ill", diag Schizophrenia. 11/18/03
Ps chos chos
OS
chiz chiz
hren hren
mani mani
Neur Neurop opsy sych chol olog ogic ical al eval evalua uati tion on 11/19/03
Psyc Psycho hosi si
NO
11120103
Psyc Psycho hosi si
NO
11120/03
te stat statin in moth mother er ca le an started.
11121/03
Psyc Psycho hosi si NO
norm normal al func functi tion onin in
ue ti ns
ed ca io
co plia plia ce
outh outh chec chec
ar
Chem Chemic ical al Depe Depend nden ency cy Eval Evalua uati tion on al atio atio
to Sign Sign Cons Consen en Form
Stud Stud Cons Consen en Form
btai btaine ne by Jean Jean Kenney and witnessed witnessed
gnat gnat re btai btai ed
Ms Kenn Kenney ey an witn witnes esse se
Exhibit 11124/03
Psyc Psycho hosi si NOS' NOS' RM egan egan stud stud sc eeni eeni g. "Sch "Schiz iz phre phre ia
6of21
er Stru Stru ture ture Cl nica nica In er ie
fo
Es ab shme shme
In pe tion tion Re
rt
FEI:
3004927371
EI Star Start: t:
01/0312005
E1 End: End:
01/26/2005
, 11/25/03
is
11128/03 11129/03 12/1104
id
re ia
id
re ic
12/2/04 12/3/04
is
12/4/04
is
12/5/04
is
ro
12/8/04 Prob Probab able le schi schizo zoph phre renia nia tory tory
lc 11124/03
#16 17. In eval evalua uati ting ng
4/15/04
#17
70f21
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3004927371
St rt
01/03/2005
E I E nd nd :
0112612005
was ourt ourt orde ordere re
11/17/03.
11/20/03 1,I>:
li in
li
ia
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was 12/11/03
try
ti
80f21
rogr rogr ss
ot
Es ab is ment ment
Insp Inspec ecti ti
Re or
3004927371
FEI :
El Start:
01103/2005
EI En
01126/2005
not As noted,
11112/03
in
11113/03 he star starte te 11/20/03
by Ms.
On 11121103
11/21/03
ro
(11113/03),
was
ep
tu
tudy tudy
ro
lu ti
(1 /1 /0 ),
espi espite te dete deteri rior orat at on
11/21103
life
"3", Mild ANSS
012 (PANSS (PANSS seve severi rity ty scal scale: e: 6'
Seve Severe rely ly ill,
bsen bsen
Mini Minima mal, l,
Ver severe severely ly iii.)
SC
12111
12/19
12/24
Mode Modera rate te Mode Modera rate tely ly Seve Severe re Minimally ill, Mildly ill, Moderately ill,
V4
V5
V6
12/31
11
1/16
G12 CGI
90f21
V7
Markedly ill,
VIO
Vll
3/31
4/28*
ta
sh en
teph teph
so
Insp Inspec ecti ti
Re or
MD
FEI:
3004927371-
tart tart
01/03/2005
nd
01/26/2005
-
Abbr Abbrev evia iate te
PANS PANS at scre screen enin in IO
av eter eter ra ed ofte ofte prev previo ious us visi visits ts." ." as ed Ms ro re furt furt er
el
te
it nn
is evel eveled ed pp aran arance ce an ar ng th am cl th as ou "A nd he escr escr ed at it er no gy
xh it aQ ]8) ther ther ise, ise, re ie fDRM fDRM re ords ords ttac ttac es ot ap ea indi indica cate te sign signif ific ican an decl declin in or dete deteri rior orat atio ion. n.
note note an corr corres espo pond nden ence ce ar high highli ligh ghte te 12111103
[stu [study] dy] Visit Visit
an
nd escr escrib ibed ed
here here fo refe refere renc nce. e.
1, "Schizophrenia" "Schizophrenia"
12119/03
cover covering ing sympto symptoms. ms. 1116104 1130/04
it 6, no
ha
RM as star starte te
re tmen tmen
si es ro me as ques ques io ed mor closel closel monito monitorin rin
ro ra
Ms me cati cati
[1114/04]
comp comp ianc ianc
an
tart tarted ed
2/26/04 2/27/04 3/2104
Visit Visit #9 "Schi "Schizop zophre hrenia nia
3/25/04
Ms en ey no es co vers versat atio io ther therap ap ap in ment ment ot alki alki
th
ot er th ra an
er fr en egar egar nrea nrea is ic an
RM canc cancel elin in ve
3/31/04
mp ms an fu ct on
el in fe." fe."
xh it #2
ag .2.Q .2.Q
4/15/04
Ms read read es fo in epen epen en li in
Mo er otes otes once oncern rn
an moth mother er stat statin ing: g: hi rneds ar rk g, e' 011t it il il msel msel some some ne el efor efor an ne 100f21
es
r.
so
yt in ."
sc sses sses
FEI:
3004927371
Star Start: t:
01103/2005 01/26/2005
4128/04 -Ab PANS PANS
comm comm nts; nts; "DRM
I; the
for
tt
teri teri
is the io
36
[It
1/14/04. Inthis
011
of tele teleco con, n, Atta Attach chme ment nt
Mr. 11 f2
#4.
ab is me te he
ls
In ecti ecti
ep rt
FEI:
MD
3004927371
El Star Start: t:
01103/2005
£J End:
01126/2005
pers pers in er ew as very very in lv ex er ence ence as ma ger. ger. reco record rds, s, disc discus ussi sion on or inte interv rvie iews ws duri during ng this this insp inspec ecti tion on of disa disagr gree eeme ment nt continuing in this this stud study. y.
er as icat icat on it DRMs DRMs enro enroll llin in or
eral erall, l, er ev ence ence of sugg sugges esti tion on or requ reques es to chan change ge DRMs DRMs trea treatm tmen en plan plan chan change ge medi medica cati tion ons, s, or re-h re-hos ospi pita tali lize ze hi nonnon-st stud ud aren arenas as note noted. d.
re mmen mmen at on ot re gi
xten xten an
th
s.
ts [a
ta ne
ad ee
comm comm tmen tmen ai
RM ma
esen esen at
atta attach ched ed as re en at
mit] mit]
ib as
pp ar
ul co
nd
nd
19 page 18.
gras gras in lian lian
ha in ed ca
ig ns
not
in
fo
ot er re so
opinion.
visi visits ts an eval evalua uati tion ons. s.
r.
iden iden
ai
er
rt
crea crea
ad ti al
lu
-h
ho
na
in
ak
show showed ed inte intent nt to comp comple lete te it
120f21
an th
en
of
ed cati cati /cha /cha
dy
tien tien
st rt beco beco in
me icat icatio io
FE!: Minneapolis,
_.---_._------'-
3004927371
EI Star Start: t:
01/03/2005
EIEnd:
01/26/2005
-----_._---
staff.
in
is
ti
ta
it
in
No
DRMs DRMs deat deathl hl AE #17'page 35)
It is
UM
up recommended. with with Inve Invest stig igat ator or Norm Isaa Isaacs cson on -- Atta Attach chme ment nt
#6.
MN
Ms.
an advocacy organization;
MN
if
Counsel, UMN, Minneapolis,
MN; and, MN
mother.
13 of21
sh
sp
FEI:
3004927371
teph tephen en Olso Olson, n, MD
EI Start: Start:
01/03/2005
is
El End:
0112612005
INSPECTION
atta atta he
ti
fo re eren eren
te ti th Exhi Exhibi bi ,#22. No un-r un-rep epor orte te devi deviat atio ions ns were were foun foun in this this insp inspec ecti tion on in
lu io
se
it in ie if ic ecor ecords ds depa depa tm nt FUMC FUMC R. Subj Subjec ec ecor ecords ds ar ti ip io is Exhi Exhibi bi #17. #17. 21 13 an 20 resp resp ctiv ctivel ely. y.
ie pe form form d, io
itne itness ss d,
s. nd do um nt
t/
in
ns
lo
in
RC
tp ie me m, ic in in me dequ dequ te to ccou ccount nt or ll subj subjec ects ts thro throug ug RM tt
io ly ti Co or subj subjec ects ts prio prio to obta obtain inin in info inform rmed ed onse onsent nt in ir it lu io ta
and 3/24/04
5/2/02, 7/1/02, 10/23/02,3/25/03,
me perf perfor orme me
se
st
mo Je th ev lu tion tion to cons cons nt nd obta obtain ined ed cons cons nt fo
Subj Subjec ects ts we
re ruit ruited ed from from th phys physic icia ians nslF lF MC Rive Rive side side ty so
in re se wa en ss an prov provid id tu
4/22/02,
in
ie
nd cont contin inui uing ng ts
ia
ti to me sign sign tu es
st li
pati pati nt popu popula lati tion on an
ef rral rral
Bo
li
cont cont ct or refe referr rr l.
ti
st
ti
nd
pp 2/11/02. ppro pprova va vi lett lett rs 2/3103 and 2/2/04. io
tt
140f21
This This te
tu ti
in
from from id
St ph
Ol on
MD
-_._---_.--------
u nd e
Di
us on
FEl:
3004927371
£1 Start:
01103/2005
EI End:
01/26/2005
wi
TO
id
#13IDRM
Exhibil#12.
8/
eRA located 1110/05. sE
Test Test arti articl cl
via an Intera Interacti ctive ve
TA
any fo revi review ew DA
AU IT
/c
tt
icid icid
150f21
FEI:
3004927371
Start:
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E1End:
01126/2005
-
Reco Record rd
re ewed ewed in hi nspe nspe tion tion an
at au it that that ar
ot else else
er
te incl incl
e:
l3IDRM
ll su ject ject re or re ar in cons consen ent, t, el ibil ibilit ity, y, adve adve se even even curr curren en stat status us etc. etc.
DI CUSS CUSS ON
Comm Commun unit it
IT
Prog Progra ra
onco onco itan itan me cati cati ns
MANA MANA EMEN EMEN
Assi Assist stan ant. t. We disc discus usse se
5/10/04
meeting 5/26/04
seve severa ra item item verb verbal ally ly incl includ udin in th foll follow owin ing. g.
3/24/04
t#2
ackn acknow owle ledg dged ed this this obse observ rvat atio ion. n. 3. Re ardi ardi ub ec reco record rd sc ssed ssed more more clea clearl rl docu docu en in hy ne ubje ubje wa co inue inue ud fter fter ea ly ecli ecli (Sub (Subje ject ct 6) sc ssio ssio th on ub ec re ar in ch ce emai emai stud stud Su je #1 ); and, and, da in corr corr ct on (Sub (Sub ec ). he bser bser at on er
ri fl disc disc se re ie reco record rd conc conc rn ng he comp compla la nt roce roce nd that that co cl de disc disc sion sion hi insp inspec ec io 160f21
We iscu iscuss ssed ed th post post-i -ins nspe pe tion tion
FEI:
3004927371
tart tart
01/03/2005
El End:
Minneapolis,
01126/2005
-------------------'-----------; -------------------' -----------;----------------------ATTACHMENTS
1.
12114/04
2.
toforward here ti ir
7.
ir
r,
ro
DRMs
othe other, r, date date
UMN
3115/04
an
4/28 4/28/0 /0 11/2/04
EXHIBITS CVs:
MD 2.
MD
le
3. oh
P.
5. Eliz Eliz et Juli 6. Juli
uche ucheti ti h, Lemk Lemk
Pear Pearso so
7. 8. 9. Christa R. Surerus-Johnson 7/9/04
Aut 5111104
170f21
Li Thomas.
Ml),
El -
..
_---_._
FEI:
3004927371
tart tart
01103/2005
End: End:
01/26/2005
11/13/03 12/8/03
Cris Crisis is Prog Progra ra rg rg
11112/03 Psyc Psyc iatr iatric ic Asse Asse sm nt icia icia rsin rsin rd
11/12/03
11112-12/8/03 11113/03 (pg
11121103 11/25103
(p
11/21103
11128/03 12/8/03 12/8/03
MN is
it
term term
ti
11121/03
15.
11/21/03
(and HIP
of21
11/24103)
FEI:
17.
in
3004927371
E1 Star Start: t:
01103/2005
E1 End:
01/26/2005
re
11)
12119/03 118/04 1116/04 1/30/04 (n at 2113104 3/31/04 11126/03
residence, 12111/03 and 12119/03
12/4/03
(pg 30)
2118104 /1
IRB re SAESAE-de deat ath: h: 5/12/04 5113/04 5/13/04 5117/04
6/1104 6/25/04
41) 5111&12/04 6/21/04 7/6104
MN
18.
MN Atty Atty Gene Genera ra M. Hatch, 7/30104 (p 47)
It
9/19-23/03
MW, 11124/03 (pg 8) MW, 4/26/04 (pg 10) 4/28/04 4/28/04
4/04
190f21
(pg 13
FEI:
3004927371
El St rt
01/03/2005
End:
01/26/2005
19. 11114103 filed 11117/03 11/14/03 11117103 11/17/03 11117/03 11120/03 11/20/03 11126103
Dr. Olson, 4127104 4/27/04
te
ro
5/3/04
5/5/04
1 11 11 4
5/5/04
(pg
1114/04 (pg 39
PA
11
2111/02 4/3/02, 12/24/03 51 1211 7/0
16) #201CL
it in
/f
re
4/28/03]
fo vi it 4/28/03 9111-12/03 1/13-14/04 4/26-27/04
7/26-27/04
200f21
is
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ta li St phen phen Olso Olson, n, MD in 26 1572 1572s, s, date dated: d:
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