Attach 3_IRB Approval

-588tr
C L I N I C A LR E S E A R C H P R O T O C O L

PR|Nc|PAL|NVEST|GAToR(NameofN|HEmployee,tn".i,,,.le@

INITIALREVIEWAPPLICATION
52,SO1
tg66427,moorete@mail.nih,gov

PROTOCOL TITLE

of

Cancer Patients from the Central

MulticenterCase-Control

ABBREVIATED
TTTLE(30 characters
or less); Survival ECERCC Sl
PROPOSEDSTARTDATE: 9/30/07
END DATE: 4/'I /1 O

TOTAL SUBJECTS TO BE ACCRUED (Atrachtarger
rablefor phasea,+;: 1097

MULTI-SITE
COLLABORATION:

IONIZING RADIATION USE (X-rays,
e.g,,ct; radjoasotopes,
e.g.pET;etc.):checkail rhatappty
e llgy
D Medicaltyindicared
O nuie"ict"inObuLo_
.
and attachto this apptication.S"nO
-:99ry19" NtH-Og-23a,
oi.i1tr" prorocorand
NIH-88-23ato Chair,RadiationSafetyfor @ncurrent
" "opy
review).
INVESTIGAT|ONAL NEW DRUG/DEV|CE:
E None
E tND
'"
'lf reporting
D tDE
morethanone IND/|DE,tiston aftach"O
FDA No.
"t."tl
IND/lDE Name
Sponsor:

ls this a multi-sitecollaboration?
E yes (complete this section) E No
Will subjects participale on the protocot at the
NIH CC? E yes Bl No
Will subjects participate on the protocol at other
sites?
E yes 6 Xe
yes,
lf
are the sites
f] Domestic
S Foreign
D Both
ls NIH the coordinating site?
participating site, provide: Institurion name,
address,
F^Y_:::
1.1."."d
Invesngator(s),
indicate if subjects wiil be recruited and if they
are, incrude a
contacl name on attached sheeuprotocol face sheet.
Et No. Coordinaring Site is-|ABC=_.-_.-

Who is the manufacturer of the above enlitv:
D@s the prctocol involve a Tech Transfer Agreemenl?

REQUESTEO ACCRUAL EXCLUSTON(Check ail rhat
apptv):
fl None
E Asian
tr Male
E Black or African American
E Female
E Children <18
E Hispanic or Latino
E American Indian/ Alaskan Native E Native Hawaiian pacific
or
lslander
SUBJECT ACCRUAL CHARACTERISTICS:
Minimum Age Permitted zg
Maximum Age Permitted e8
Pediatric
ENone
D<2yr.
tr2-6yrs.
tr7-17yrs.
Protocol involves healthy volunteers?
tr yes
E No
Are Healthy Volunteers NIH Employees? E yes
E No
Doestheprotocol permitselfreferral?
D yes
E No
Will lhe protocol involve adults unable to give informed consent?
E yes

EYes

ENo

jt proto€ot.invotve a drug/device/product that may tead to you or rhe NtH
9T:
recevtng
payment and/or royallies?
O Yes (Append a statement of disclosure)
8No
Has the NIH IRP COI Guide been distributedto
NIH Investigators?
BYes
DNo
Has the NIH IRP COI Guide been distributedto Non_NlH
Investigators?
El Yes
tr No
D N/A
coNFLtcTS OF TNTERESTREytEW,

Daresubmitred
to tc DEC:lY

ila
OT
Darectearedov tc oec:
ll /Zo//
/Oa
ls an Extramurar
Investigator
an ADJUNCTpRrNcrpALTNVESIGATo(? atyu. nruo
Nameof Adjunctpt: Dr. Paul Brennan

D No

PROTOCOL ryPE: (Check onei:
fl Screening
D Training
E Naturat History - Disease progression/ physiology

MEDICALADVISORYTNVESTTGATOR
(if necessary)
Name,InsUBranch,
Tetephone,
Address,Emailand initialline:

*
patrenrs)
Coilection
or nnarisis(Recruirrns
=
9"mp1e1Dara
u I*Ti
Naturat l-li3l9V
Htslory - Sample/Data

Collectionor Analysis (NotRecruiting
palrenrs)
D Pharmacokinetics/Dynamics
tr ClinicalTrial: tdentitr/phase (Check one)
DPhase0
Dphasel
Uphasel-2
D Phase 2
O phase 3
f] phase 4

LEAD ASSOCIATE INVESTIGATOR _ Name, InsVBranch,
Tetephone,Address, Emait.
Check box if an NIH employee and initial line:

E

lfa Phase 3 Clinical Trial, is analysis for sex, raciat/ethnicsubgroups
requtred
accordng to the NIH Policy and Guidelines on the Inclusionof-women
and Minorities
as Subiects in Clinical Research? D yes
tr No
D N/A

RESEARCH CONTACT: Name, InsVBranch,Telephone,
Address, Email. Check box if
an NIH employee and initial line:

KEY WORDS (Words or phrase that describe the orotocol.)

ASSOCIAT_EINVESTtGATOR(S):Name, Institute/Branch,Tetephone,
Address, Email.
Check box if an NIH employee and initial line. Attach list if necessarv.

1.

Or Wonqh

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4.8
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A

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SIGNATURE

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Cb.

Nat Folhmah.

NCUTEG

cipal Investigator

RECOMMENDATION
Investigator

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Dr Psul Brennan |ARC. 33-4-7273S9 t, t50 coufs Alhn
Dr. Mia Ha$ib€,

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APPROVALS

Sl4S47m,

NCyOCEG.S14s4719.6t20

Investigator:

Dr.LeeEMoore
ffi

Execudv€ gvd EpS s1@ RckMlte MD &8s2. ch(w@6xchsF.dh.@v

At€d

Thoms

69@a Lyon Fraft€, brennan o€rc.,,

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Send to Accountable Investigator

O7

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'03

Send to Branch Chief, or CC
Dept. Head of Accountable Investigator
Send to Institute/Center Scientific Revrew
Committee
Send to Clinical Director

6
08

PATIENTSAFETY/
RESOURCE
REVIEW

Send to Chaif, Institutional Review Board

Send to Office of Prot@ol Services,
thrcugh IRB Protocol Coordinator
Return to Office of Proto@l Setuices,
(10/'152318)

COMPLETION
Specrahsl

PRorocoLNo.

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7

Clinical Research Protocol Initial Review Applicatioi

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