Form 1 CTRP Registration Batch Upload Template

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Overview

Disclaimer
Readme First
Template Instructions
Abbreviated Trial Data Spec

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Sheet 1: Disclaimer

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Sheet 2: Readme First

CTRP Trial Registration Participating Site Specification for Abbreviated Trials
The participating sites template is designed for recording participating site data for interventional trials, especially if site-specific data is not included in the trial protocol.
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.
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
	4	Valid values. The system accepts only those values listed in this document
	5	Comments. Additional information that helps you to ensure successful submission of your data

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Sheet 3: Template Instructions

How to Submit Abbreviated Trial Participating Sites Data to the CTRP Trial Registration System
Main Steps for Uploading Your Data
1	Prepare the trial data file
2	Upload the file in the Trial-Related Documents section in the Registration application
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
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.
	* Conform to the valid values guidelines when entering trial data.
	* Identify each trial uniquely
	* Participating site information must include the following data elements:
		* Study participating site data
		* At least one study site investigator's information
		* Participating site primary or central contact information. Generic contact information is accepted.
		* Organization attribute
		* Current recruitment status
		* Status date
		* Target accrual. This is mandatory if the target accrual is for a study at a participating site or if the lead organization is an NCI-designated Cancer Center. Optionally, provide a local trial identifier.
	* Study site investigator's information must include the following data elements:
		* Study site investigator data with person's attributes
		* Investigator's role in the study at the site.
		Note: When registering multiple investigators for a single trial, create one line per investigator/site, using the participating site number as reference.
	* Participating site contact information is optional if the contact person is the investigator, or if the central contact information is provided.
	* 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.
Uploading Your File
Upload your file in the Trial-Related Documents section of the CTRP Registration Site's Register Trial page. Or, email your file to the CTRO at [email protected].
		Note: You can use the Abbreviated Batch Upload Template instead of this one. If you use the batch template, identify the trial to which you want to add your site information by its NCI Trial ID.
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: Abbreviated Trial Data Spec

Trial elements Order	Trial data element	Required?	Valid Values	Comments	Definition
1	NCI Trial Identifier	Yes		NCI trial identifier of the existing in CTRP trial to which this site is to be added
2	Local trial identifier	Yes		Trial identifier as assigned by the submitting organization
3	[Submitting Organization] Organization PO-ID			PO-ID or all mandatory organization attributes are required
4	[Submitting Organization] Name	Yes if PO-ID is not provided
5	[Submitting Organization] Street Address	Yes if PO-ID is not provided
6	[Submitting Organization] City	Yes if PO-ID is not provided
7	[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
8	[Submitting Organization] Zip/Postal code	Yes if PO-ID is not provided
9	[Submitting Organization] Country	Yes if PO-ID is not provided
10	[Submitting Organization] Email Address	Yes if PO-ID is not provided
11	[Submitting Organization] Phone			Include Phone Extension if any in the same field
12	[Submitting Organization] TTY
13	[Submitting Organization] FAX
14	[Submitting Organization] URL
15	[Submitting Organization] Organization Type		Institution, ordering group, repository, research based, cooperative group, cancer center, consortium, drug company, network
16	[Site Principal Investigator] Person PO-ID			PO-ID or all mandatory person attributes are required
17	[Site Principal Investigator] First Name	Yes if PO-ID is not provided
18	[Site Principal Investigator] Middle Name
19	[Site Principal Investigator] Last Name	Yes if PO-ID is not provided
20	[Site Principal Investigator] Street Address	Yes if PO-ID is not provided
21	[Site Principal Investigator] City	Yes if PO-ID is not provided
22	[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
23	[Site Principal Investigator] Zip/Postal code	Yes if PO-ID is not provided
24	[Site Principal Investigator] Country	Yes if PO-ID is not provided
25	[Site Principal Investigator] Email Address	Yes if PO-ID is not provided
30	[Site Principal Investigator] Phone	Yes if PO-ID is not provided		Phone specific to study
31	[Site Principal Investigator] Phone Extension			Mandatory if exists and PO-ID is not provided
32	[Site specific] Program Code			applicable for NCI-designated Cancer Center
33	Site Recruitment Status	Yes	Not yet recruiting; Recruiting; Enrolling by invitation; Active, not recruiting; Completed; Suspended; Terminated; Withdrawn
34	Site Recruitment Status Date	Yes	Format mm/dd/yyyy	Date when the recruitment status has come in effect
35	Date Opened for Accrual	Yes if study is opened for accrual	Format mm/dd/yyyy
36	Date Closed for Accrual	Yes if study is closed for accrual	Format mm/dd/yyyy
37	Site Target Accrual			Necessary for NCI designated cancer centers