1 CTRP Registration Abbreviated Participating Sites Templa

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Overview

Disclaimer
Readme First
Template Instructions
Sample
Abbreviated Trial Data Spec
2-letter state_province

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Sheet 1: Disclaimer

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Sheet 2: Readme First

CTRP Trial Registration Batch Upload Specification for Abbreviated Trials
About this Document
This document provides you with everything you need to upload clinical trial data to the CTRP Trial Registration system, including the following:
Template Instructions
	The Template Instructions worksheet provides detailed instructions for preparing your data and uploading them to the system.
Sample Trial Data
	The Sample Trial Data worksheet provides an example of what a typical batch upload file looks like.
	Note: A batch upload file must contain only one (1) worksheet (tab)
Batch Upload Data Element Specifications
	The specifications worksheet includes the following information:
	1	Data elements
	2	Order in which the data elements must be presented
	3	Data element requirements. Requirements differ for original updated, and amended submissions.
	4	Valid values. The system accepts only those values listed in this document.
	5	Comments. Additional information that helps you to ensure successful upload of your data.
State and Provence Codes
	The State and Province Codes worksheet lists the 2- or 3-letter state/province/territory codes for the United States, Canada, and Australia.

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Sheet 3: Template Instructions

How to Submit Abbreviated Trial Data to the CTRP Trial Registration System
Before You Begin
Contact the CTRO at [email protected] to request approval for sending batch files to CTRP. Include your login name, first and last names, and email address stored in your CTRP profile.
Note: Once you have received approval, you do not have to request approval for subsequent batches.
Main Steps for Uploading Your Data
1	Prepare the trial data file
2	Email your files to the CTRO at [email protected]
Note: CTRO staff will register your trials using your batch file data. As the trial submitter, the CTRO maintains trial ownership by default.
To transfer trial ownership email the CTRO with the first name, last name and email address of the person who will manage your registered trials. The new owner must be a registered CTRP account holder.
Preparing Trial Data Files
1	Ensure that your trial conforms to the supported criteria. This template supports the following:
	*	Interventional trials
	*	Abbreviated trials (Summary 4 Funding Sponsor Category is Industrial)
	*	Updates to abbreviated CTRP trials with the processing status "Accepted" and beyond
	*	100 trials per data file
2	Prepare an Excel spreadsheet (.xls) containing the mandatory and optional data for the trial(s) as specified in this document.
	You must adhere to the following requirements:
	* List trial elements required for registration in the order specified in the Abbreviated Trial Data Spec tab in this spreadsheet.
	* Do not change the spelling of data elements or valid values. Changes to spelling or to the order of the trial elements will cause the upload to fail. Similarly, the addition of new/extra trial elements will also cause a failure.
	* Conform to the valid values guidelines when entering trial data. Valid values for each of the trial elements, where applicable, are listed under Column D in the Abbreviated Trial Data Spec tab in this spreadsheet.
	* Identify each trial uniquely. For example, append your cancer center unique trial identifier to the file name.
	* If you provide an NCT number the primary purpose, phase, disease and intervention data are not required.
	* If a trial is identified as a duplicate to an existing trial, you can request to add your organization information to the existing trial as a participating site using the same template or create a separate request using the Participating Sites Template for abbreviated trials and email it to the CTRO at [email protected].
	* If more than one disease or intervention is included, list them on additional lines, one per line when adding local trial identifier to the first column (see Sample Trial Data tab).
	* List persons and organizations with PO-IDs.
			Note: You can request a list of CTRP persons and organizations along with PO-IDs from the CTRO at [email protected].
			Or, you can use the organization/person lookup features in the CTRP Trial Registration application to search for PO-IDs.
Emailing Your Files
Email your file as an attachment to the CTRO at [email protected].
For detailed instructions for registering trials, refer to the NCI CTRP Reporting Program Registration Site User's Guide at:
	https://wiki.nci.nih.gov/x/7qViAw

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Sheet 4: Sample

Local Trial Identifier

Submission Type

NCI Trial Identifier

[Submitting Organization] Organization PO-ID

[Submitting Organization] Name

[Submitting Organization] Street Address

[Submitting Organization] City

[Submitting Organization] State/Province

[Submitting Organization] Zip/Postal code

[Submitting Organization] Country

[Submitting Organization] Email Address

[Submitting Organization] Phone

[Submitting Organization] TTY

[Submitting Organization] FAX

[Submitting Organization] URL

[Submitting Organization] Organization Type

Is Submitting Organization a NCI Designated Cancer Center?

[Lead Organization] CTEP Organization PO-ID

[Lead Organization] Name

[Lead Organization] Street Address

[Lead Organization] City

[Lead Organization] State/Province

[Lead Organization] Zip/Postal code

[Lead Organization] Country

[Lead Organization] Email Address

[Lead Organization] Phone

[Lead Organization] TTY

[Lead Organization] FAX

[Lead Organization] URL

[Lead Organization] Organization Type

Lead Organization Trial Identifier

NCT Trial Identifier

Title

Trial Type

Primary Purpose

If Primary Purpose is 'Other', describe

Phase

Pilot Trial?

[Site Principal Investigator] Person PO-ID

[Site Principal Investigator] First Name

[Site Principal Investigator] Middle Name

[Site Principal Investigator] Last Name

[Site Principal Investigator] Street Address

[Site Principal Investigator] City

[Site Principal Investigator] State/Province

[Site Principal Investigator] Zip/Postal code

[Site Principal Investigator] Country

[Site Principal Investigator] Email Address

[Site Principal Investigator] Phone

[Site Principal Investigator] TTY

Site [Principal Investigator] FAX

[Site Principal Investigator] URL

Summary 4 Funding Sponsor/Source Category

[Summary 4 Funding Sponsor/Source] Organization PO-ID

[Summary 4 Funding Sponsor/Source] Organization Name

[Summary 4 Funding Sponsor/Source] Street Address

[Summary 4 Funding Sponsor/Source] City

[Summary 4 Funding Sponsor/Source] State/Province

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

[Summary 4 Funding Sponsor/Source ] Country

[Summary 4 Funding Sponsor/Source ] Email Address

[Summary 4 Funding Sponsor/Source ] Phone

[Summary 4 Funding Sponsor/Source ] TTY

[Summary 4 Funding Sponsor/Source ] FAX

[Summary 4 Funding Sponsor/Source ] URL

[Submitting Site specific] Program Code

Site Recruitment Status

Site Recruitment Status Date

Date Opened for Accrual

Date Closed for Accrual

Site Target Accrual

Disease Name

Intervention Type

Intervention Name

Trial Owner First Name

Trial Owner Last Name

Trial Owner Email Address

1

O

Mayo Clinic Hospital

5777 East Mayo Boulevard

Phoeniz

AZ

85054

United States

[email protected]

Research Based

Yes

12345

cancer center

Phase III study of priming with granulocyte-macrophage colony stimulating factor (rhu-gm-csf)and of three induction regimens in adult patients (over 55) with acute non-lymphocytic leukemia

Interventional

Other

Laboratory

III

Harry

Long

5777 East Mayo Boulevard

Phoeniz

AZ

85054

United States

[email protected]

123-345-7654

Industrial

Novartis Pharmaceuticals Corporation

One Health Plaza

East Hanover

NJ

07936-1080

United States

[email protected]

Active

03/01/2009

03/01/2009

50

acute non-lymphocytic leukemia

Biological/Vaccine

granulocyte-macrophage colony stimulating factor

Mary

Smith

[email protected]

1

stage III non-lymphocytic leukemia

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Sheet 5: Abbreviated Trial Data Spec

Trial elements Order	Trial data element	Required?	Valid Values	Comments	Definition
1	Local Trial Identifier	Yes		Trial identifier as assigned by the submitting organization
2	Submission Type	Yes	O, U	O- Original is default. U-update	Original submission is the first time submission of a trial to CTRP. Update means submitting an update to the already registered trial in CTRP.
3	NCI Trial Identifier	Yes for submitting update only		Ignored in case of original submission
4	[Submitting Organization] Organization PO-ID			PO-ID or all organization mandatory attributes are required
5	[Submitting Organization] Name	Yes if PO-ID is not provided
6	[Submitting Organization] Street Address	Yes if PO-ID is not provided
7	[Submitting Organization] City	Yes if PO-ID is not provided
8	[Submitting Organization] State/Province	Yes for US/Canada/Australia and if PO-ID is not provided	2-letter state/province code required for US/Canada, 2-3 letter code required for Australia
9	[Submitting Organization] Zip/Postal code	Yes if PO-ID is not provided
10	[Submitting Organization] Country	Yes if PO-ID is not provided
11	[Submitting Organization] Email Address	Yes if PO-ID is not provided
12	[Submitting Organization] Phone			Include Phone Extension if any in the same field
13	[Submitting Organization] TTY
14	[Submitting Organization] FAX
15	[Submitting Organization] URL
16	[Submitting Organization] Organization Type		Institution, ordering group, repository, research based, cooperative group, cancer center, consortium, drug company, network
17	Is Submitting Organization a NCI Designated Cancer Center?	Yes	yes, no	no is default
18	[Lead Organization] CTEP Organization PO-ID			PO-ID or all organization mandatory attributes is required
19	[Lead Organization] Name	Yes if PO-ID is not provided
20	[Lead Organization] Street Address	Yes if PO-ID is not provided
21	[Lead Organization] City	Yes if PO-ID is not provided
22	[Lead Organization] State/Province	Yes for US/Canada/Australia and if PO-ID is not provided	2-letter state/province code required for US/Canada, 2-3 letter code required for Australia
23	[Lead Organization] Zip/Postal code	Yes if PO-ID is not provided
24	[Lead Organization] Country	Yes if PO-ID is not provided
25	[Lead Organization] Email Address	Yes if PO-ID is not provided
26	[Lead Organization] Phone	Yes if PO-ID is not provided		Include Phone Extension if any in the same field
27	[Lead Organization] TTY
28	[Lead Organization] FAX
29	[Lead Organization] URL
30	[Lead Organization] Organization Type		Institution, ordering group, repository, research based, cooperative group, cancer center, consortium, drug company, network
31	Lead Organization Trial Identifier	Yes		AS IS in the protocol document & assigned by the lead organization
32	NCT Trial Identifier			This value or at least one disease and one intervention record are required in attached proprietary trial template
33	Title	Yes	Max 4000 characters	Title from the protocol document
34	Trial Type	Yes	Interventional, Observational	Currently only Interventional trials are accepted
35	Primary Purpose	Yes, if NCT number is not provided	Treatment, Prevention, Supportive Care, Screening, Diagnostic, Health Service Research, Basic Science, Other	Mandatory if value in row 32 is NULL (if NCT number is NULL)
36	If Primary Purpose is 'Other', describe	Yes, if Primary Purpose value is 'Other'		Provide free text value if Primary Purpose value is 'Other'. Not aplicable if Primary Purpose is not 'Other'
37	Phase	Yes, if NCT number is not provided	0, I, I/II, II, II/III, III, IV, N/A	Mandatory if value in row 32 is NULL (if NCT number is NULL)
38	Pilot Trial?		Yes, No	Only applicable if Phase is 'N/A; Default is No
39	[Site Principal Investigator] Person PO-ID			PO-ID or all mandatory person attributes are required
40	[Site Principal Investigator] First Name	Yes if PO-ID is not provided
41	[Site Principal Investigator] Middle Name
42	[Site Principal Investigator] Last Name	Yes if PO-ID is not provided
43	[Site Principal Investigator] Street Address	Yes if PO-ID is not provided
44	[Site Principal Investigator] City	Yes if PO-ID is not provided
45	[Site Principal Investigator] State/Province	Yes for US/Canada/Australia and if PO-ID is not provided	2-letter state/province code required for US/Canada, 2-3 letter code required for Australia
46	[Site Principal Investigator] Zip/Postal code	Yes if PO-ID is not provided
47	[Site Principal Investigator] Country	Yes if PO-ID is not provided
48	[Site Principal Investigator] Email Address	Yes if PO-ID is not provided
49	[Site Principal Investigator] Phone	Yes if PO-ID is not provided		Include Phone Extension if any in the same field
50	[Site Principal Investigator] TTY
51	Site [Principal Investigator] FAX
52	[Site Principal Investigator] URL
53	Summary 4 Funding Sponsor/Source Category	Yes	Industrial
54	[Summary 4 Funding Sponsor/Source] Organization PO-ID	PO-ID or the rest of mandatory attribute for the organization is mandatory
55	[Summary 4 Funding Sponsor/Source] Organization Name	Yes if PO-ID is not provided
56	[Summary 4 Funding Sponsor/Source] Street Address	Yes if PO-ID is not provided
57	[Summary 4 Funding Sponsor/Source] City	Yes if PO-ID is not provided
58	[Summary 4 Funding Sponsor/Source] State/Province	Yes if PO-ID is not provided and for the following courtiers: USA, Canada and Australia	2-letter state/province code required for US/Canada, 2-3 letter code required for Australia
59	[Summary 4 Funding Sponsor/Source] Zip/Postal code	Yes if PO-ID is not provided
60	[Summary 4 Funding Sponsor/Source ] Country	Yes if PO-ID is not provided
61	[Summary 4 Funding Sponsor/Source ] Email Address	Yes if PO-ID is not provided
62	[Summary 4 Funding Sponsor/Source ] Phone
63	[Summary 4 Funding Sponsor/Source ] TTY
64	[Summary 4 Funding Sponsor/Source ] FAX
65	[Summary 4 Funding Sponsor/Source ] URL
66	[Submitting Site specific] Program Code	Yes for NCI designated cancer center	Submitting Site specific	Submitting Site specific, 'Not specified' is default. Mandatory if value in row 17 is 'yes'.
67	Site Recruitment Status	Yes	Not yet recruiting; Recruiting; Enrolling by invitation; Active, not recruiting; Completed; Suspended; Terminated; Withdrawn
68	Site Recruitment Status Date	Yes		Date when the recruitment status has come in effect
69	Date Opened for Accrual	Yes if study is or was opened for accrual
70	Date Closed for Accrual	Yes if study is or was closed for accrual
71	Site Target Accrual	Yes for NCI designated Cancer Center		Mandatory if value in row 17 is 'yes'. '0' can be used if value is unknown
72	Disease Name	Yes if NCT number is not provided		If more that one disease is provided, use the additional line for a new disease (see Trial Data Sample)
73	Intervention Type	Yes if NCT number is not provided	Drug, Device, Biological/Vaccine, Procedure/Surgery, Radiation, Behavioral, Genetic, Dietary Supplement, Other	If more that one intervention is provided, use the additional line for an additional intervention (see Trial Data Sample)
74	Intervention Name	Yes if NCT number is not provided		If more that one intervention is provided, use the additional line for an additional intervention (see Trial Data Sample)
75	Trial Owner First Name	Yes		This information is required for trial ownership transfer. Note: user must be registered in CTRP
76	Trial Owner Last Name	Yes		This information is required for trial ownership transfer. Note: user must be registered in CTRP
77	Trial Owner Email Address	Yes		This information is required for trial ownership transfer. Note: user must be registered in CTRP

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Sheet 6: 2-letter state_province

Country	Country 3-letter code	State/Province	2-3 letter state/province code	Old values
UNITED STATES	USA
		Alabama	AL
		Alaska	AK
		Arizona	AZ
		Arkansas	AR
		California	CA
		Colorado	CO
		Connecticut	CT
		Delaware	DE
		Florida	FL
		Georgia	GA
		Hawaii	HI
		Idaho	ID
		Illinois	IL
		Indiana	IN
		Iowa	IA
		Kansas	KS
		Kentucky	KY
		Louisiana	LA
		Maine	ME
		Maryland	MD
		Massachusetts	MA
		Michigan	MI
		Minnesota	MN
		Mississippi	MS
		Missouri	MO
		Montana	MT
		Nebraska	NE
		Nevada	NV
		New Hampshire	NH
		New Jersey	NJ
		New Mexico	NM
		New York	NY
		North Carolina	NC
		North Dakota	ND
		Ohio	OH
		Oklahoma	OK
		Oregon	OR
		Pennsylvania	PA
		Rhode Island	RI
		South Carolina	SC
		South Dakota	SD
		Tennessee	TN
		Texas	TX
		Utah	UT
		Vermont	VT
		Virginia	VA
		Washington	WA
		West Virginia	WV
		Wisconsin	WI
		Wyoming	WY
CANADA	CAN
		Alberta	AB
		British Columbia	BC
		Manitoba	MB
		New Brunswick	NB
		Newfoundland and Labrador	NL
		Northwest Territories	NT
		Nova Scotia	NS
		Nunavut	NU
		Ontario	ON
		Prince Edward Island	PE
		Quebec	QC
		Saskatchewan	SK
		Yukon	YT
AUSTRIA	AUT
		Australian Capital Territory	ACT
		New South Wales	NSW
		Northern Territory	NT
		Queensland	QLD
		South Australia	SA
		Tasmania	TAS
		Victoria	VIC
		Western Australia	WA