Att 13_NCI IRB Approval

5 ?t z
CLINICALRESEARCHPROTOCOL
INITIALREVIEWAPPLICATION

PRINCIPAL INVESTIGATOR (Name of NIH Employee, Institute/Branch,Address, Telephone and email):
ArlhurSchaEkin,MD,Dr.PH NEEVDCEG,6120exsutiveblvd
Rockville,MD20852;301-594-2931;schaEka@mailnihgov

PROTOCOLTITLE:

Feasibilitystudyof a web-basedautomatedself-administered
24-hourdietaryrecall(ASA241anda physicalactivity24-hourrecall
(30characters
ABBREVIATED
TTTLE
or tess): ASM4/ACTz4 feasibility study
PROPOSEDSTARTOnTE: 5/1/08

END DATE: 4/30/09

TOTALSUBJECTSTO BE ACCRUED(Attach
tarsettabtefq enases-+1:2,093

MULTI.SITE
COLLABORATION.
ls this a multi-sitecollaboration?E Yes (crmpletethis section) El No
VMllsubjec{sparticipateon the protocolat the NIH CC? D Yes E No
Vvillsubjectsparticipateon the protocolat othersites? O Yes E No
lf yes, are the sites
El Domestic
E Foreign
E Both
ls NIH the coordinatingsite?
D Yes. For each participatingsite, provide:Institutionname,address,
investigator(s),
indicateif subjectswill be recruitedand if they are, includea
contactnameon attachedsheeuprtocol face sheet
D No. CoordinatingSite

IONIZING RADIATION USE 1xays, e g , CT: Edioisotopes,e g PET: etc ): checkail that appty
E None
B
Medically indicated
E Research indicated'
*CompleteNIH€&23a. ild attiachto this appli€tion
Ssd a @py of entireprctmt and
NIH€&23a to Chair,Radiatitr Safetytor orcurent Eviil)

(Checkall thatapply):
REQUESTED
ACCRUALEXCLUSION
E None
tr Asian
tr Male
tr Blackor AfricanAmerican
E Female
tr White
<18
E Children
tr Hisoanicor Latino
El AmericanIndian/AlaskanNative O NativeHawaiianor Pacificlslander

Doesthe protocd involvea Tech TransferAgreement?

SUBJECTACCRUALCHARACTERISTICS:
MinimumAge Permitted 50
MaximumAge Permitted none
Pediatric
B None
E File Typeapplication/pdfFile Modified2008-05-30File Created2008-05-30