3 Attach 5B CTRP Registry Complete Trial Participating Sit

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Overview

Disclaimer
Readme First
Template Instructions
Participating Site Data Spec
Collaborator Data Spec
Participating Site example
Collborator example

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Sheet 1: Disclaimer

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Sheet 2: Readme First

CTRP Trial Registration Participating Site Specification for Complete 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 participating sites and collaborator 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.
Participating Site Data Specification and Collaborator Data Specification
	The specifications worksheets 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	Notes. Additional information that helps you to ensure successful submission of your data
Participating Site and Collaborator Examples
	These worksheets provide examples of a typical participating sites/collaborator data file.

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Sheet 3: Template Instructions

How to Submit Complete 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
	*	Complete trials (Data Table 4 Funding Sponsor Category is National, Externally Peer Reviewed, or Institutional
	*	Processing Statuses for trial updates: Accepted and beyond
	*	Processing Statuses for trial amendments: Abstraction Verified Response or Abstraction Verified No Response
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 Participating Site 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.
		Note: Although you can update Program Codes via the NCI CTRP Registration site, you can not update them via the batch file.
Uploading Your File
Upload your file in the Trial-Related Documents section of the CTRP Registration Site's Register Trial page.
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/7ZF4B

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Sheet 4: Participating Site Data Spec

Element order	Element	Required?	Allowed values	Note
	Study participating site data			For participating sites only; lead organization must be included if it is also a participating site
1	Site #	Yes		Order in the list of participating sites
2	Local Trial Identifier			Trial identifier at site
3	[Site] Organization PO-ID	Yes		PO-ID for the organization must exist in the CTRP list of organizations
4	Study Current Recruitment Status at site	Yes	Not yet recruiting; Recruiting; Enrolling by invitation; Active, not recruiting; Completed; Suspended; Terminated; Withdrawn
5	Study Current Recruitment Status date	Yes	Date in the format mm/dd/yyyy	Date that corresponds to the current recruitment status change
6	Site Target Accrual	Yes if either site or lead organization is cancer center	Number	Mandatory if either site or lead organization is cancer center
7	Program Code			Site-specific Data Table 4 program code for NCI designated cancer center
	Study site investigator's information			Several records per one participating site are accepted
8	Investigator's Person PO-ID			PO-ID for the Person must exist in the CTRP list of Persons
9	Investigator's Role in the study	Yes	Principal Investigator, Sub-Investigator
10	Use investigator as site contact for the study	Yes	Yes/No	IF YES is selected, investigator will play participating site contact role for the study and no other participating site contact will be required
	Study/Site Contact information
11	Contact type	Yes	Site-Specific, Study-specific or central	Provide single contact for the study (study-specific) or site-specific contact for each participating site. This attribute is not required if site's investigator is assigned as site contact. There is no need to replicate central contact in each participating site record if central contact is selected and provided in the first record
	Generic Contact			Generic contact or personal contact is required
12	Title for generic contact	Yes if generic contact is used		Several records per one participating site are accepted in case of site-specific contact type
13	Contact Email	Yes if generic contact is used		Email address specific to study
14	Contact Phone	Yes if generic contact is used		Phone specific to study
15	Contact Phone Extension			Mandatory if exists
	Person Contact
16	Contact Person's PO-ID			PO-ID for the Person must exist in the CTRP list of Persons
17	Contact Email	Yes if personal contact is used and PO-ID is not provided		Email address specific to study
18	Contact Phone	Yes if personal contact is used and PO-ID is not provided		Phone specific to study

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Sheet 5: Collaborator Data Spec

#	Element	Mandatory?	Value	Note
	Collaborator information	Optional
1	Collaborator #			Order in the list of collaborators
2	Collaborator Organization PO-ID			PO-ID for the organization must exist in the CTRP list of organizations
3	Collaborator role on the study	Yes	Funding Source, Agent Source, Laboratory

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Sheet 6: Participating Site example

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Site info

Site #

Local Trial Identifier

[Site] Organization PO-ID

Study Current Recruitment Status at site

Study Current Recruitment Status date

Site Target Accrual

Program Code

Site Investigator

Investigator's Person PO-ID

Investigator's Role in the study

Use investigator as site contact for the study

Site Contact Info

Contact type

Genetic Contact

Title

Contact Email Address

Contact Phone

Contact Phone Extension

Personal Contact

Contact Person's PO-ID

Contact Email

Contact Phone

Note

Study 1

1

LI01

321

recruiting

10/20/2008

55

BM3

12345

Principal Investigator

YES

Site-Specific

Site is a NCI designated cancer center, includes 2 investigators. One of the investigators is selected as this site contact.

1

23456

Sub-investigator

NO

2

LI02

432

recruiting

11/2/2008

125

34567

Principal Investigator

NO

Site-Specific

[email protected]

212-639-2000

Site is a NCI designated cancer center, includes 1 investigator. Site-Specific contact is used (investigator is not used for site contact)

Study 2

1

LI04

432

recruiting

11/2/2008

125

34567

Principal Investigator

NO

Study_specific

Clinical Study Department

[email protected]

212-639-2000

123

Generic study-specific contact is used; no need to provide contact for each site separately.

2

LI06

321

recruiting

10/20/2008

55

BM3

12345

Principal Investigator

NO

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Sheet 7: Collborator example

1	2	3
Collaborator #	Collaborator Organization PO-ID	Collaborator role on the study
1	123	Laboratory
2	234	Agent Source