02-CC-0247 CR Approval

/o
MarionDanis,M.D.,CC/BE,l0/lCl18, 301435-8727

CONTINUINGREVIEWAPPLICATION

PRorocol TIrLE:y"|u". at the Bedside:A Surveyof EuropeanPhysiciansRegardingEthicalDilemmasin ClinicalPractice
-Recruitrnentofparticipants
has notyet begun
-Participantsare currentlybeing recruitedor enrolled
-No longer recruitingor enrollingparticipants,subjectfollow-uponly
-Participantshave completedstudy;study and data analysesongoing
O Renew
-ClinicalHold/Recruitment
O Renew
or enrollmentof participantssuspended
O Terminate -Studyclosed.Participantshave completedstudy.Recruitmentand
data analysiscomplete
O Renew
I Renew
' 'lenew

-rays,e g ,
, etc ) check all
that apply:
A
None
tr
Medicallyindicated
tr
Researchindicated Since the last review,
tr ResearchusageHAS NOT changed
D ResearchusageHAS changed (Explainin summaryreport)
INVESTIGATIONAL
NEW DRUG/DEVICE:E None tr IND
tr IDE
'lf reportingmorethanone IND/IDE,liston attachedsheet.

SUMMARYOF PROTOCOLENROLLMENT(Aggregate):Ontywtren
theNtHis the
totalsandenrcllment
lableforothersite
coordinaling
sile,provide
Total
NIH Site
Other Sites

FDA No

2100

Accrualceilingby IRB
New subjectsaccruedsince last CR

Sponsor

656

Aggregate total accrued

Who is the manufacturerof the aboveentitv?

Are you cunentlyrecruitinghealthyvolunteers?
ENo
Will the protocolinvolveadults unableto give inform€dconsent? E| No

tr Yes
tr Yes

Doesthe protocolinvolvea Tech TransferAgreement?

Have analysesby sex, raciayethnicsubgroupsbeen conductedfor Phase3 Clinical
Trialsas required? tr No
E Yes (answera and b) E N/A
a Have analysesbeen reported?D No (explainin narrative) O Yes
b. Have significantdifferencesbeen found? O No tr Yes

trNo
tr Yes (ldentifythe personsor sites and describethe collaborationin the
summaryreport)
WITHTHISREVIEW,I AM REQUESTING
A CHANGETO THE FOLLOWING:
Name. InsUBEnch. Telephme, Addrss,

e{ail

D Yes

that may lead to you or the NIH
Doesthe protocolinvolvea drug/device/product
receivingpaymentand/orroyalties?
trNo
O
Yes (Appenda stiatementof disclosure)
Havethere been any amendmentssince the last revieM
ENo
Yes (Describebrieflyin the attiachednarrative)
tr

Have any non-NlHlnvestigatorsor sites been added sincethe last review?

'lnclude

E No

Check box if an NIH Employee and initial

line Atlachshet if n&essry

Havethere been any changesin the informedconsentprocessor documentationsince
the last review?
BNo
Yes (Describein Summaryreport)
O
Havethere been any changesin the subjectpopulation,recruitmentor selectioncriteria
sincethe last review?
El
No
E
Yes (Explainchangesin the aftachednanative)

PRINCIPAL INVESTIGATOR

Del€te:
Add': E
AOJUNCTPRINCIPALINVESTIGATOR:
EXTRAMURAL

Have any unexpectedcomplicationsor side effectsbeen notedsincethe last review?
ENo
tr
Yes (ldentif and explainin the attachednarrative)

Delete:

MEDICALADVISORYINVESTIGATOR:

Have any subjectswithdrawnfrom this study since the last IRB approval?
qNo
Yes (Discussin the attachednarrative)
tr

Delete:
Add':

Has any informationappearedin the literature,or evolvedfrom lhis or similarresearch,
that mightaffectthe IRB's evaluationof the risUbenefitanalysisof humansubjects
involvedin this protocol?
lNo
Yes (Discussin the attachednarrative.)

LEADASSOCIATEINVESTIGATOR:
Delete:
Add': f-l
RESEARCHCONTACT:

Has the NIH IRP COI Guide been distributedto new NIH investigators?
trNo
trYes
FN/A
Has the NIH IRP COI Guide been distributedto new Non-NlHinvestigators?

Delete:

Add': E

tr No

ASSOCIATEINVESTIGATOR(S)

tr Yes

El N/A

CONFLICTS
OFINTEREST
REVIEW?
Datecleared
to lC DEC:_
bylC DEC:
Datesubmitted

Oelete:

Add': El

MarionDanis.M.D.

SIGNATURE
Inv€slrgalor

o-?

MarionDanis.M.D.

RECOMMENDATION

Send lo Accounlable Investigator

ype Name

o-7

to B€nch Chief.or CC

PrinuTwe Name -

F*r*+lltHfti;-

Dept Hed

o7

Date

PrinvTypeName

Davidl{e+rdqson, M.D

APPROVALS

'
M

Date

of Accountable Investrgator

Send to Clini€l

T*^o

Direclor

Institutional

"chair,
Review
Board

Dato 5

Send to Office of Prot@ol Seryrces,

thrcughIRB PrctocolCoordinator
Approved Effectrve

COMPLETION
ProtocolSpecialist

I ClinicalResearchProtocolContinuingReviewApplication
(9.06)
I NrH.1195.1