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					CTRP Trial Registration Batch Upload Specification V2.2

I. Getting ready to send the batch file 1. Prior to your initial batch submission please contact NCI Apps Support to gain approval to send batch fi 1a. NCI Apps Support may be reached at ncicb@pop.nci.nih.gov or 888-478-4423 1b. Once step 1a has been accomplished you will no longer need to contact Apps Support prior to sendin 2. Access the NCI Trial Registration application batch upload web page (at https://trials.nci.nih.gov/registry 2a. An Excel spreadsheet (.xls) containing mandatory and optional data for the trial(s) 2b. A separate zip file containing applicable trial documents (e.g. Protocol or Proprietary Trial Template; I

II. Instructions for preparing the trial data file 1. The trial elements required for registration should be listed in the order specified in the Batch Upload D 2. Each trial should be uniquely identified (this can be your cancer center unique trial identifier) 3. This version of the spec: 3a. Supports information on a single grant (only) per trial submitted 3b. Supports a single IND/IDE (only) per submitted trial 3c. Supports up to 100 trials per data file 3d. Supports only interventional trials

III. Instructions for preparing the trial documents zip file 1. Rename the document files by prefixing the unique trial identifier on the existing file name. Example: XX 2. Make sure each of the document file names prefixed with trial identifiers are unique per trial. 3. Provide the document names in the file containing the trial data. Up to 5 files can be specified in one sin 4. Zip all the trial documents. Please do not include any pathname in the zip file.

roval to send batch files to CTRP

upport prior to sending subsequent batch files als.nci.nih.gov/registry/admin/batchUpload.action) where sites may upload:

tary Trial Template; IRB approval; Informed Consent; Participating Sites; Change Memo) for the trials in the data file

the Batch Upload Data Element Spec tab in this spreadsheet identifier)

e name. Example: XXXX_document_name e per trial. be specified in one single trial record

e trials in the data file

Trial elements Order
1 2

Trial data element

Required?

Unique Trial Identifier Lead Organization Trial Identifier

Yes Yes

3

NCT

4 5

Title Trial Type

Yes Yes

6

Primary Purpose

Yes

7

Primary Purpose 'Other' value specification

Yes if Primary Purpose = 'Other'

8 9

Phase Phase 'Other' value specification

Yes Yes if Phase = 'Other'

10 11 12 13 14

[Sponsor] Organization Name [Sponsor] CTEP Organization Number (CTEP Identifier) [Sponsor] Street Address [Sponsor] City [Sponsor] State/Province

Yes

Yes Yes Yes for US/Canada/Australia

15 16 17

[Sponsor] Zip/Postal code [Sponsor] Country [Sponsor] Email Address

Yes Yes Yes

18 19 20 21 22 23

[Sponsor] Phone [Sponsor] TTY [Sponsor] FAX [Sponsor] URL Responsible Party [Sponsor Contact] First Name

Yes Yes if Responsible Party is Sponsor

24

[Sponsor Contact] Middle Name

25

[Sponsor Contact] Last Name

Yes if Responsible Party is Sponsor

26

[Sponsor Contact] CTEP Person Number (CTEP Identifier) [Sponsor Contact] Street Address Yes if Responsible Party is Sponsor Yes if Responsible Party is Sponsor Yes if country is USA, Canada or Australia and Responsible Party is Sponsor Yes: if Responsible Party is Sponsor Yes if Responsible Party is Sponsor Yes: if Responsible Party is Sponsor Yes: if Responsible Party is Sponsor

27

28

[Sponsor Contact] City

29

[Sponsor Contact] State/Province

30

[Sponsor Contact] Zip/Postal code

31

[Sponsor Contact] Country

32

[Sponsor Contact] Email Address

33

[Sponsor Contact] Phone

34 35 36 37

[Sponsor Contact] TTY [Sponsor Contact] FAX [Sponsor Contact] URL [Lead Organization] Name

Yes

38

[Lead Organization] CTEP Organization Number (CTEP Identifier)

39

[Lead Organization] Street Address

Yes

40

[Lead Organization] City

Yes

41

[Lead Organization] State/Province

Yes for US/Canada/Australia

42 43 44

[Lead Organization] Zip/Postal code [Lead Organization] Country [Lead Organization] Email Address

Yes Yes Yes

45 46 47 48 49

[Lead Organization] Phone [Lead Organization] TTY [Lead Organization] FAX [Lead Organization] URL [Lead Organization] Organization Type

50

[Principal Investigator] First Name

Yes

51 52

[Principal Investigator] Middle Name [Principal Investigator] Last Name Yes

53 54

[Principal Investigator] CTEP Person Number (CTEP Identifier) [Principal Investigator] Street Address Yes

55

[Principal Investigator] City

Yes

56

[Principal Investigator] State/Province

Yes for US/Canada/Australia

57

[Principal Investigator] Zip/Postal code

Yes

58

[Principal Investigator] Country

Yes

59

[Principal Investigator] Email Address

Yes

60

[Principal Investigator] Phone

Yes

61 62 63 64

[Principal Investigator] TTY [Principal Investigator] FAX [Principal Investigator] URL Summary 4 Funding Category For interventional trial only and if Lead Org or any Participating Org is NCIdesignated Cancer Center Yes

65

[Summary 4 Funding Sponsor/Source] Organization Name

66

[Summary 4 Funding Sponsor/Source] CTEP Organization Number (CTEP Identifier)

67

[Summary 4 Funding Sponsor/Source] Street Address

Yes

68

[Summary 4 Funding Sponsor/Source] City

Yes

69

[Summary 4 Funding Sponsor/Source] State/Province

Yes if country is USA, Canada or Australia

70

[Summary 4 Funding Sponsor/Source] Zip/Postal code

Yes

71

[Summary 4 Funding Sponsor/Source ] Country

Yes

72

[Summary 4 Funding Sponsor/Source ] Email Address

Yes

73 74 75 76 77

[Summary 4 Funding Sponsor/Source ] Phone [Summary 4 Funding Sponsor/Source ] TTY [Summary 4 Funding Sponsor/Source ] FAX [Summary 4 Funding Sponsor/Source ] URL Program Code

78 79 80 81

[NIH Grant] Funding Mechanism [NIH Grant] Institute Code [NIH Grant] Serial Number [NIH Grant] NCI Division/Program Code

Yes: if NIH grant exists Yes: if NIH grant exists Yes: if NIH grant exists Yes: if NIH grant exists

82

Current Trial Status

Yes

83

Why Study Stopped?

Yes if Current Trial Status is Withdrawn, Temporary Closed to Accrual, Temporary Closed to Accrual and Intervention or Administratively Complete Yes Yes

84 85

Current Trial Status Date Study Start Date

86

Study Start Date Type

Yes

87

Primary Completion Date

Yes

88

Primary Completion Date Type

Yes

89 90 91 92 93

IND/IDE Type IND/IDE Number IND/IDE Grantor IND/IDE Holder Type [IND/IDE] NIH Institution

Yes: if IND/IDE trial Yes: if IND/IDE trial Yes: if IND/IDE trial Yes: if IND/IDE trial If (IND/IDE Holder Type) = NIH

94

[IND/IDE] NCI Division /Program

If (IND/IDE Holder Type) = NCI Yes If (Has Expanded Access?) = Yes

95 96

[IND/IDE] Has Expanded Access? [IND/IDE] Expanded Access Status

97

Protocol Document File Name

Yes

98

IRB Approval Document File Name

Yes

99

Participating Sites Document File Name

100

Informed Consent Document File Name

101

Other Trial Related Document File Name

Valid Values

Comments

Proprietary trial data specification (only applicable if value is not known)

Max 4000 characters Interventional, Observational

Treatment, Prevention, Supportive Care, Screening, Early Detection, Diagnostic, Epidemiologic, Outcome, Observational, Ancillary, Correlative, Health Service Research, Other, Basic Science

AS IS in the protocol document & assigned by the lead organization Unique identifier assigned to the published trial by PRS (ClinicalTrials.gov) Title from the protocol document Currently only Interventional trials are accepted If 'other' selected, specify in 'Other' if you do not know the 7 actual value

'Unknown' if you do not know the actual value and Primary Purpose value is 'Other'

0, I, I/II, II, II/III, III, IV, Pilot, N/A, Other

If 'other' selected, specify in 'Other' if you do not know the 9 actual value 'Unknown' if you do not know the actual value and Phase value is 'Other' Note: industry sponsor info

2-letter state/province code required for US/Canada, 2-3 letter code required for Australia 3-letter country code required

Include Phone Extension if any in the same field

PI, Sponsor

Sponsor 'unknown' if you don't know the name of the sponsor contact person name Applicable to Responsible party = 'Sponsor' only 'unknown' if you don't know the name of the sponsor contact person name Applicable to Responsible party = 'Sponsor' only 'unknown' if you don't know the name of the sponsor contact person name 'unknown' if you don't know the name of the sponsor contact person name 'MD' if you don't know the name of the sponsor contact person name

2-letter state/province code required for US/Canada, 2-3 letter code required for Australia

'12345' if you don't know the name of the sponsor contact person name 3-letter country code required 'USA' if you don't know the name of the sponsor contact person name 'ncictro@mail.nih.gov' if you don't know the sponsor contact person name Include Phone Extension if '111-111-1111' if you don't any in the same field know the name of the sponsor contact person name

'unknown' if you don't know the name of the lead organization

'unknown' if you don't know the name of the lead organization 'unknown' if you don't know the name of the lead organization 2-letter state/province code required for US/Canada, 2-3 letter code required for Australia 'MD' if you don't know the name of the lead organization

3-letter country code required

'12345' if you don't know the name of the lead organization 'USA' if you don't know the name of the lead organization 'ncictro@mail.nih.gov' if you don't know the name of the lead organization Include Phone Extension if any in the same field

Institution, ordering group, repository, research based, cooperative group, cancer center, consortium, drug company, network 'unknown' if you don't know the name of the study principal investigator

'unknown' if you don't know the name of the study principal investigator

2-letter state/province code required for US/Canada, 2-3 letter code required for Australia

'unknown' if you don't know the name of the study principal investigator 'unknown' if you don't know the name of the study principal investigator 'MD' if you don't know the name of the study principal investigator '12345' if you don't know the name of the study principal investigator

3-letter country code required

'USA' if you don't know the name of the study principal investigator 'ncictro@mail.nih.gov' if you don't know the name of the study principal investigator Include Phone Extension if '111-111-1111' if you don't any in the same field know the name of the study principal investigator

National, Externally PeerReviewed, Institutional, Industrial

applicable if Lead Org or Participating Org is NCIdesignated Cancer Center

'Industrial'

applicable if Lead Org or Note: Industry - funding Participating Org is NCIsponsor/source designated Cancer Center applicable if Lead Org or Participating Org is NCIdesignated Cancer Center applicable if Lead Org or Participating Org is NCIdesignated Cancer Center applicable if Lead Org or Participating Org is NCIdesignated Cancer Center 2-letter state/province code required for US/Canada, 2-3 letter code required for Australia applicable if Lead Org or Participating Org is NCIdesignated Cancer Center applicable if Lead Org or Participating Org is NCIdesignated Cancer Center 3-letter country code required applicable if Lead Org or Participating Org is NCIdesignated Cancer Center applicable if Lead Org or Participating Org is NCIdesignated Cancer Center

Include Phone Extension if any in the same field

Summary 4 element, no LOV exists, codes are specific to cancer centers Refer Funding Mechanism in Valid Values worksheet. Refer Institute Code in Valid Values worksheet. format: 5 or 6 digits Refer NCI Division/Program Code in Valid Values worksheet. Specify only the code. In Review, Approved, Active, Closed to Accrual, Closed to Accrual and Intervention, Temporary Closed to Accrual, Temporary Closed to Accrual and Intervention, Complete, Administratively Complete

Defaults to N/A if not specified

Note that trials with current 'Approved' if you don't know trial status 'Withdrawn' are the current trial status not accepted. Please use 'In Review' status at submission of pre-IRB approved study.

Mandatory if Current Trial Status is Withdrawn, Temporary Closed to Accrual, Temporary Closed to Accrual and Intervention or Administratively Complete Date when the status has came in effect '01/01/1900' if you don't know the current trial status

Date that enrollment to the '01/01/1999' if you don't know protocol begins the current trial status

Actual, Anticipated

Only current/past date (in 'Anticipated' if you don't know respect to batch upload the current trial status date) is accepted for actual type and only future date is accepted for anticipated type. 'Anticipated' type is valid for 'In Review' and 'Approved' current trial status only. 'Actual' type is valid for any other current trial status besides 'In Review' and 'Approved'. For more information check State-Dates tab in this file. Date that the final subject '01/01/1999' if you don't know was examined or received the current trial status an intervention for the purposes of final collection of data for the primary outcome, whether the clinical trial concluded according to the prespecified protocol or was terminated Only current/past date (in 'Anticipated' if you don't know respect to batch upload the current trial status date) is accepted for actual type and only future date is accepted for anticipated type. 'Actual' type is valid for 'Administratively Complete' or 'Complete' current trial statuses only. 'Anticipated' type is valid for any other current trial status besides 'Administratively Complete' or 'Complete'. For more information check StateDates tab in this file.

Actual, Anticipated

IND, IDE CDER, CBER, CDRH Investigator, Organization, Industry, NIH, NCI Refer NIH Institution in Valid Values worksheet.

if IND/IDE trial

Refer NCI Division/Program if IND/IDE trial Code in Valid Values worksheet. Yes, No if IND/IDE trial Available, No longer available, if IND/IDE trial Temporarily not available, Approved for marketing Prefix unique trial identifier Note: protocol document file to document name name or proprietary template file name Prefix unique trial identifier Empty file is OK to document name. Dummy file if IRB approval is not required with the statement 'IRB' approval is not required'. Dummy file is required with the name of Review Board (address, phone, email) and Board Affiliation name in case of pre-IRB approved studies submission. One IRB Approval is only needed. Requited if case of multisite trial and if the participation sites information is not included in the protocol document. Prefix unique trial identifier to document name Requited if is not included in the protocol document. Prefix unique trial identifier to document name Prefix unique trial identifier to document name

NOTE: These are the valid values for the data elements. They are presented in vertical format - no relation across

Funding Mechanism B09 C06 DP1 DP2 DP3 D43 D71 E11

Institute Code AA AG

NCI Division/Program Code CCR CTEP DCB

AI AO AR

DCCPS DCEG DTP

AT DCP BC DEA CA OD

F05 F30 F31 F32 F33 F34 F37 F38 G07 G08 G11 G12 G13 G20 G94 HD4 H13 H25 H28 H50 H57 H62 H64

CB OSB/SPOREs CL CIP CM CDP CN CO CP N/A CT DA DC DE DK EB ES EY GM GW HB HC HD HG HI HL HO TRP RRP

H75 H79 I01 KD1 KL1 KL2 K01 K02 K05 K06 K07 K08 K12 K14 K18 K22 K23 K24 K25 K26 K30 K99 L30 L32 L40 L50 L60 M01 PL1 PN1 PN2 P01 P20 P30 P40 P41 P42 P50 P51 P60 P76 RC1 RC2 RC3 RL1 RL2 RL5 RL9 RS1 R00 R01 R03 R04 R06 R08

HR HV JT LM MD MH NB NR NS OD OF OL OR PC SC SF WH RC RG RM RR TW WT

R13 R15 R17 R18 R21 R24 R25 R30 R33 R34 R36 R37 R41 R42 R43 R44 R49 R55 R56 R90 SC1 SC2 SC3 S06 S10 S11 S21 S22 TL1 TU2 T01 T02 T09 T14 T15 T32 T34 T35 T36 T37 T42 T90 UA1 UC1 UC2 UC3 UC6 UC7 UE1 UE2 UD1 UH1 UH2 UH3 UL1

UR3 UR6 UR8 US3 US4 UT1 UT2 U01 U09 U10 U11 U13 U17 U18 U19 U24 U34 U1A U1Q U1S U1T U1V U21 U22 U23 U27 U2G U2R U30 U32 U36 U38 U41 U42 U43 U44 U45 U47 U48 U49 U50 U51 U52 U53 U54 U55 U56 U57 U58 U59 U60 U61 U62 U65 U66

U75 U79 U81 U82 U83 U84 U87 U90 VF1 X01 X02 X98 Z02

no relation across

NIH Institution NEI-National Eye Institute NHLBI-National Heart, Lung, and Blood Institute NHGRI-National Human Genome Research Institute NIA-National Institute on Aging NIAAA-National Institute on Alcohol Abuse and Alcoholism NIAID-National Institute of Allergy and Infectious Diseases NIAMS-National Institute of Arthritis and Musculoskeletal and Skin Diseases NIBIB-National Institute of Biomedical Imaging and Bioengineering NICHD-Eunice Kennedy Shriver National Institute of Child Health and Human Development NIDCD-National Institute on Deafness and Other Communication Disorders NIDCR-National Institute of Dental and Craniofacial Research NIDDK-National Institute of Diabetes and Digestive and Kidney Diseases NIDA-National Institute on Drug Abuse NIEHS-National Institute of Environmental Health Sciences NIGMS-National Institute of General Medical Sciences NIMH-National Institute of Mental Health NINDS-National Institute of Neurological Disorders and Stroke NINR-National Institute of Nursing Research NLM-National Library of Medicine CIT-Center for Information Technology CSR-Center for Scientific Review FIC-John E. Fogarty International Center for Advanced Study in the Health Sciences NCCAM-National Center for Complementary and Alternative Medicine NCMHD-National Center on Minority Health and Health Disparities NCRR-National Center for Research Resources (NCRR CC-NIH Clinical Center OD-Office of the Director

A Unique Trial Identifier

B C Lead NCT Organization Trial Identifier

D Title

E Trial Type

F Primary Purpose

1 A Phase I study of Taxol in refractory leukemia in children Phase III Study of Zoladex Adjuvant to Radiotherapy in Unfavorable Prognosis Carcinoma of the Prostate

2

10 CCG-0903

NCT000123

Interventional Treatment

3

1000 RTOG-85-31

Interventional Treatment

4

2001 GOG-9201

5

3000 E3993

A Phase I trial of Ifosfamide and Taxol in refractory Pelvic Malignancies Interventional Treatment Phase III study of priming with granulocyte-macrophage colony stimulating factor (rhu-gmcsf)and of three induction regimens in adult patients (over 55) with acute non-lymphocytic leukemia Interventional Treatment Phase III Comparison of Methotrexate, Vinblastine, Doxorubicin, and Cisplatin (MVAC) vs. Doxorubicin and Cisplatin (AC) in Women with Advanced Primary or Recurrent Metastatic Carcinoma of the Uterine Endometrium Interventional Treatment

6

NCCTG-904000 60-51

G H Primary Purpose Phase 'Other' value specification 1

I Phase 'Other' value specification

J K [Sponsor] [Sponsor] Organization Name CTEP Organization Number

2

I

Children's Oncology Group C001

3

III

Radiation Therapy Oncology Group

RT0098

4

I

Gynecologic Oncology Group

GC009

5

III

Eastern Cooperative Oncology Group EC6000

6

III

North Central Cancer Treatment Group

NCT123

L [Sponsor] Street Address

M [Sponsor] City

N [Sponsor] State/Province

O [Sponsor] Zip/Postal code

1

2 2115 E Jefferson St

Rockville

MD

20185

3 200 Water Street

New York

NY

22102

4 100 Main St

Fairfax

VA

22032

5 100 Village Lane

Boston

MA

11760

6 200 Springdale Rd

Hartford

CT

33333

P [Sponsor] Country

Q [Sponsor] Email Address

R [Sponsor] Phone

S [Sponsor] TTY

1

2 USA

test@cog.org

222-444-8888

3 USA

222-444-8888

4 USA

222-444-8888

5 USA

222-444-8888

6 USA

222-444-8888

T [Sponsor] FAX

U [Sponsor] URL

V Responsible Party

W X [Sponsor [Sponsor Contact] First Contact] Middle Name Name

Y [Sponsor Contact] Last Name

1

2

PI

3

Sponsor

4

Sponsor

5

Sponsor

6

Sponsor

Z AA [Sponsor Contact] [Sponsor CTEP Person Contact] Number Street Address 1

AB AC [Sponsor [Sponsor Contact]C Contact] ity State/Provin ce

AD [Sponsor Contact] Zip/Postal code

AE [Sponsor Contact] Country

AF [Sponsor Contact] Email Address

2

3

4

5

6

AG [Sponsor Contact] Phone 1

AH AI [Sponsor Contact] TTY [Sponsor Contact] FAX

AJ [Sponsor Contact] URL

AK AL [Lead [Lead Organization Organization ] Name ] CTEP Organization Number Gynecologic Oncology Group GC009

AM [Lead Organization ] Street Address

2

100 Main St

3

4

Children's Oncology Group North Central Cancer Treatment Group

C001

2115 E Jefferson St

NCT123

100 Meadow Rd

5

North Central Cancer Treatment Group

NCT123

100 Meadow Rd

6

Children's Oncology Group

C001

2115 E Jefferson St

AN AO [Lead [Lead Organization] Organization] State/Province City 1

AP AQ AR [Lead [Lead [Lead Organization] Organization] Organization] Email Address Zip/Postal Country code

2 Fairfax

VA

22032 USA

3 Rockville

MD

20185 USA

4 Hartford

CT

33333 USA

5 Hartford

CT

33333 USA

6 Rockville

MD

20185 USA

AS [Lead Organization] Phone

AT AU AV AW AX [Lead [Lead [Lead [Lead [Principal Organization] Organization] Organization] Organization] Investigator] TTY FAX URL Organization First Name Type

1 cooperative group

2

Nita

3

Miljenko

4

cooperative group

Maurie

5

cooperative group

Jacob

6

cooperative group

Harry

AY AZ [Principal [Principal Investigator] Investigator] Middle Name Last Name 1

BA [Principal Investigator] CTEP Person Number

BB [Principal Investigator] Street Address

BC [Principal Investigator] City

BD [Principal Investigator] State/Provinc e

BE [Principal Investigator] Zip/Postal code

2

Seibel

2424 17297 Springdae Rd Milwaukee

WI

53186

3 B

Pilepich

100 Village 9300 Hill Lane

Natick

MA

01760

4

Markman

9977 100 Main St

Boston

MA

34567

5 J

Rowe

100 Old 10528 Meadow Rd

Houston

TX

33323

6

Long

100 Old 6975 Meadow Rd

Houston

TX

32323

BF [Principal Investigator] Country 1

BG [Principal Investigator] Email Address

BH [Principal Investigator] Phone

BI [Principal Investigator] TTY

BJ [Principal Investigator] FAX

BK [Principal Investigator] URL

BL Summary 4 Funding Category

2 USA

nseibel@cnm c.org

3 USA

MPilepich@m ednet.ucla.ed u

Institutional

4 USA

mmarkman@ mdanderson. org

5 USA

rowe@ramba m.health.gov. il

6 USA

long.harry@ mayo.edu

BM [Summary 4 Funding Sponsor/Sour ce] 1 Organization Name 2 North Central Cancer Treatment 3 Group

BN [Summary 4 Funding Sponsor/Sour ce] CTEP Organization Number

BO [Summary 4 Funding Sponsor/Sour ce] Street Address

BP [Summary 4 Funding Sponsor/Sour ce] City

BQ [Summary 4 Funding Sponsor/Sour ce] State/Provinc e

BR [Summary 4 Funding Sponsor/Sour ce] Zip/Postal code

BS [Summary 4 Funding Sponsor/Sour ce ] Country

4

5

6

BT [Summary 4 Funding Sponsor/Sour ce ] Email 1 Address

BU [Summary 4 Funding Sponsor/Sour ce ] Phone

BV [Summary 4 Funding Sponsor/Sour ce ] TTY

BW [Summary 4 Funding Sponsor/Sour ce ] FAX

BX BY [Summary 4 Program Funding Code Sponsor/Sour ce ] URL

BZ [NIH Grant] Funding Mechanism

2

1 F34

3

4

IM

K08

5

6

CA CB [NIH Grant] [NIH Grant] Institute Code Serial Number 1

CC CD [NIH Grant] Current Trial NCI Status Division/Progr am Code

CE Why Study Stopped?

CF Current Trial Status Date

CG Study Start Date

2 AG

72345 CTEP

Complete Accrual target was reached for this phase of the study

9/1/2007

9/1/2008

3

Temporary Closed to Accrual

9/2/2007

9/2/2008

4 HV

9752

Approved

9/3/2007

9/3/2008

5

Complete

9/4/2007

9/4/2008

6

Complete

9/5/2007

9/5/2008

CH Study Start Date Type

CI Primary Completion Date

CJ Primary Completion Date Type

CK CL IND/IDE Type IND/IDE Number

CM IND/IDE Grantor

CN IND/IDE Holder Type

1

2 Actual

10/1/2010 Anticipated

3 Anticipated

10/2/2010 Anticipated

4 Actual

10/3/2010 Anticipated

5 Anticipated

10/4/2010 Anticipated

6 Anticipated

10/5/2010 Anticipated

IND

67899 CDER

NIH

CO [IND/IDE] NIH Institution 1

CP [IND/IDE] NCI Division /Program

CQ [IND/IDE] Has Expanded Access?

CR [IND/IDE] Expanded Access Status

CS Protocol Document File Name

CT CU IRB Approval Participating Document Sites File Name Document File Name

2

10_protocol_ document.do 10_IRB_Appr 10_Participati c oval.doc ng_Sites.xls

3

1000_protoco 1000_IRB_Ap 1000_Particip l_document.d proval_06082 ating_Sites_n oc 007.doc ew.xls

4

2001_protoco 2001_Particip l_document.d 2001_IRB_Ap ating_Sites.xl oc proval.doc s

5

3000_protoco 3000_Particip l_document.d 3000_IRB_Ap ating_Sites.xl oc proval.doc s

6 NIA

Yes

4000_protoco 4000_Particip Approved for l_document.d 4000_IRB_Ap ating_Sites.xl marketing oc proval.doc s

CV Informed Consent Document File Name 1

CW Other Trial Related Document File Name

10_Informed_ 10_Other_do 2 Consent.PDF cument.doc

1000_Informe 1000_Other_ d_Consent.P document_12 34.doc 3 DF

2001_Informe 2001_Other_ d_Consent.P document.do c 4 DF

3000_Informe 3000_Other_ d_Consent.P document.do c 5 DF

4000_Informe 4000_Other_ d_Consent.P document.do c 6 DF

Illustration for assigning current status/status date, start and primary completion dates. Diagram includes Current Trial Status line (top), Start Date line with type (below the Current Trial Status line) and Primary Completion line (bottom)

1. Current trial status date must be past/current. 2. Actual start date type is valid for any current trial status besides 'In Review' and 'Approved' 3. Anticipated start date type is only valid for current trial status 'In Review' and 'Approved' 4. Anticipated start date type turns into actual start date type when current trial status becomes 'Active'. If current trial status is 'Active', start date must be the same as the current trial status date for the initial or smaller than the current trial status date if the 'Active' status is the recurrent status. 5. Actual primary completion date type is only valid for current trial status 'Administratively Complete' or 6. Anticipated primary completion date type is valid for current trial status other than 'Administratively Co If current trial status is 'Complete' or 'Administratively Complete', primary completion date must be the s 7. Only current/past date (in respect to batch upload date) is accepted for actual type and only future date (in respect to batch upload date) is accepted for anticipated type. 8. If the current trial status is Withdrawn, Temporary Closed to Accrual, Temporary Closed to Accrual an the reason 'Why Study Stopped?' must be provided.

primary completion dates.

imary Completion line (bottom)

n Review' and 'Approved' Review' and 'Approved' current trial status becomes 'Active'. current trial status date for the initial study activation. e recurrent status. tatus 'Administratively Complete' or 'Complete' status other than 'Administratively Complete' or 'Complete' imary completion date must be the same or bigger than the date of the preceding current trial status date (if one exists). ed for actual type r anticipated type. ual, Temporary Closed to Accrual and Intervention or Administratively Complete

te (if one exists).

NCI Division/Program Code CCR CTEP DCB DCCPS DCEG DTP DCP DEA OD OSB/SPOREs

Definition Center for Cancer Research Cancer Therapy Evaluation Program Division of Cancer Biology Division of Cancer Control and Population Sciences Division of Cancer Epidemiology and Genetics Developmental Therapeutics Program Division of Cancer Prevention Division of Extramural Activities Office of the Director, NCI, NIH Organ Systems Branch (OSB) /Specialized Programs of Research Excellence (SPOREs) Cancer Imaging Program Cancer Diagnosis Program Translational Research Program Radiation Research Program Not applicable

CIP CDP TRP RRP N/A

Country AFGHANISTAN ALBANIA ALGERIA AMERICAN SAMOA ANDORRA ANGOLA ANGUILLA ANTARCTICA ANTIGUA AND BARBUDA ARGENTINA ARMENIA ARUBA AUSTRALIA AUSTRIA AZERBAIJAN BAHAMAS BAHRAIN BANGLADESH BARBADOS BELARUS BELGIUM BELIZE BENIN BERMUDA BHUTAN BOLIVIA BOSNIA AND HERZEGOWINA BOTSWANA BOUVET ISLAND BRAZIL BRITISH INDIAN OCEAN TERRITORY BRUNEI DARUSSALAM BULGARIA BURKINA FASO BURUNDI CAMBODIA CAMEROON CANADA CAPE VERDE CAYMAN ISLANDS CENTRAL AFRICAN REPUBLIC CHAD CHILE CHINA CHRISTMAS ISLAND COCOS (KEELING) ISLANDS COLOMBIA COMOROS CONGO COOK ISLANDS COSTA RICA

3-letter code AFG ALB DZA ASM AND AGO AIA ATA ATG ARG ARM ABW AUS AUT AZE BHS BHR BGD BRB BLR BEL BLZ BEN BMU BTN BOL BIH BWA BVT BRA IOT BRN BGR BFA BDI KHM CMR CAN CPV CYM CAF TCD CHL CHN CXR CCK COL COM COG COK CRI

COTE D'IVOIRE CROATIA (local name: Hrvatska) CUBA CYPRUS CZECH REPUBLIC DENMARK DJIBOUTI DOMINICA DOMINICAN REPUBLIC EAST TIMOR ECUADOR EGYPT EL SALVADOR EQUATORIAL GUINEA ERITREA ESTONIA ETHIOPIA FALKLAND ISLANDS (MALVINAS) FAROE ISLANDS FIJI FINLAND FRANCE FRANCE, METROPOLITAN FRENCH GUIANA FRENCH POLYNESIA FRENCH SOUTHERN TERRITORIES GABON GAMBIA GEORGIA GERMANY GHANA GIBRALTAR GREECE GREENLAND GRENADA GUADELOUPE GUAM GUATEMALA GUINEA GUINEA-BISSAU GUYANA HAITI HEARD AND MC DONALD ISLANDS HOLY SEE (VATICAN CITY STATE) HONDURAS HONG KONG HUNGARY ICELAND INDIA INDONESIA IRAN (ISLAMIC REPUBLIC OF) IRAQ

CIV HRV CUB CYP CZE DNK DJI DMA DOM TMP ECU EGY SLV GNQ ERI EST ETH FLK FRO FJI FIN FRA FXX GUF PYF ATF GAB GMB GEO DEU GHA GIB GRC GRL GRD GLP GUM GTM GIN GNB GUY HTI HMD VAT HND HKG HUN ISL IND IDN IRN IRQ

IRELAND ISRAEL ITALY JAMAICA JAPAN JORDAN KAZAKHSTAN KENYA KIRIBATI KOREA, DEMOCRATIC PEOPLE'S REPUBLIC OF KOREA, REPUBLIC OF KUWAIT KYRGYZSTAN LAO PEOPLE'S DEMOCRATIC REPUBLIC LATVIA LEBANON LESOTHO LIBERIA LIBYAN ARAB JAMAHIRIYA LIECHTENSTEIN LITHUANIA LUXEMBOURG MACAU MACEDONIA, THE FORMER YUGOSLAV REPUBLIC OF MADAGASCAR MALAWI MALAYSIA MALDIVES MALI MALTA MARSHALL ISLANDS MARTINIQUE MAURITANIA MAURITIUS MAYOTTE MEXICO MICRONESIA, FEDERATED STATES OF MOLDOVA, REPUBLIC OF MONACO MONGOLIA MONTSERRAT MOROCCO MOZAMBIQUE MYANMAR NAMIBIA NAURU NEPAL NETHERLANDS NETHERLANDS ANTILLES NEW CALEDONIA NEW ZEALAND NICARAGUA

IRL ISR ITA JAM JPN JOR KAZ KEN KIR PRK KOR KWT KGZ LAO LVA LBN LSO LBR LBY LIE LTU LUX MAC MKD MDG MWI MYS MDV MLI MLT MHL MTQ MRT MUS MYT MEX FSM MDA MCO MNG MSR MAR MOZ MMR NAM NRU NPL NLD ANT NCL NZL NIC

NIGER NIGERIA NIUE NORFOLK ISLAND NORTHERN MARIANA ISLANDS NORWAY OMAN PAKISTAN PALAU PANAMA PAPUA NEW GUINEA PARAGUAY PERU PHILIPPINES PITCAIRN POLAND PORTUGAL PUERTO RICO QATAR REUNION ROMANIA RUSSIAN FEDERATION RWANDA SAINT KITTS AND NEVIS SAINT LUCIA SAINT VINCENT AND THE GRENADINES SAMOA SAN MARINO SAO TOME AND PRINCIPE SAUDI ARABIA SENEGAL SEYCHELLES SIERRA LEONE SINGAPORE SLOVAKIA (Slovak Republic) SLOVENIA SOLOMON ISLANDS SOMALIA SOUTH AFRICA SOUTH GEORGIA AND THE SOUTH SANDWICH ISLANDS SPAIN SRI LANKA ST. HELENA ST. PIERRE AND MIQUELON SUDAN SURINAME SVALBARD AND JAN MAYEN ISLANDS SWAZILAND SWEDEN SWITZERLAND SYRIAN ARAB REPUBLIC TAIWAN, PROVINCE OF CHINA

NER NGA NIU NFK MNP NOR OMN PAK PLW PAN PNG PRY PER PHL PCN POL PRT PRI QAT REU ROM RUS RWA KNA LCA VCT WSM SMR STP SAU SEN SYC SLE SGP SVK SVN SLB SOM ZAF SGS ESP LKA SHN SPM SDN SUR SJM SWZ SWE CHE SYR TWN

TAJIKISTAN TANZANIA, UNITED REPUBLIC OF THAILAND TOGO TOKELAU TONGA TRINIDAD AND TOBAGO TUNISIA TURKEY TURKMENISTAN TURKS AND CAICOS ISLANDS TUVALU UGANDA UKRAINE UNITED ARAB EMIRATES UNITED KINGDOM UNITED STATES UNITED STATES MINOR OUTLYING ISLANDS URUGUAY UZBEKISTAN VANUATU VENEZUELA VIET NAM VIRGIN ISLANDS (BRITISH) VIRGIN ISLANDS (U.S.) WALLIS AND FUTUNA ISLANDS WESTERN SAHARA YEMEN YUGOSLAVIA ZAIRE ZAMBIA ZIMBABWE

TJK TZA THA TGO TKL TON TTO TUN TUR TKM TCA TUV UGA UKR ARE GBR USA UMI URY UZB VUT VEN VNM VGB VIR WLF ESH YEM YUG ZAR ZMB ZWE

Country UNITED STATES

Country 3-letter code USA

State/Province Alabama Alaska Arizona Arkansas California Colorado Connecticut Delaware Florida Georgia Hawaii Idaho Illinois Indiana Iowa Kansas Kentucky Louisiana Maine Maryland Massachusetts Michigan Minnesota Mississippi Missouri Montana Nebraska Nevada New Hampshire New Jersey New Mexico New York North Carolina North Dakota Ohio Oklahoma Oregon Pennsylvania Rhode Island South Carolina South Dakota Tennessee Texas Utah Vermont Virginia Washington West Virginia Wisconsin Wyoming

CANADA

CAN Alberta British Columbia Manitoba New Brunswick Newfoundland and Labrador Northwest Territories Nova Scotia Nunavut Ontario Prince Edward Island Quebec Saskatchewan Yukon

AUSTRIA

AUT Australian Capital Territory New South Wales Northern Territory Queensland South Australia Tasmania Victoria Western Australia

2-3 letter state/province code AL AK AZ AR CA CO CT DE FL GA HI ID IL IN IA KS KY LA ME MD MA MI MN MS MO MT NE NV NH NJ NM NY NC ND OH OK OR PA RI SC SD TN TX UT VT VA WA WV WI WY

Old values

AB BC MB NB NL NT NS NU ON PE QC SK YT ACT NSW NT QLD SA TAS VIC WA


				
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