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Introduction

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Trials are conducted in participating sites. You must provide information about the site itself (organization), the investigator(s), and primary contacts (if a central contact is not provided). Optionally, you can include contact information for a person’s title (functional role) rather than a person’s name. When you add a participating site to a trial, link (associate) an organization, site, investigator(s), and primary site contact information to it.

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Providing a site contact is optional if you provide a central contact instead.

Info

The system assigns investigators and primary contacts a status code that corresponds to the person’s/role’s curation status.

Information about participating sites can be included in the protocol document or in the Participating Sites document.

Info
titleCheck out the trial before you begin abstraction

Before you begin abstracting or validating any trial, be sure you check it out first. Otherwise you will not be able to modify any trial data.

How to Abstract Participating Site Information 

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On the Administrative Data menu, click Participating Sites. The Participating Sites page appears.

Click Add.

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The Participating Sites page displays three tabbed sections: Participating Site, Investigators, and Contact. The Participating Sites tab is displayed by default. 

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Participating Site tab of the Add Edit Participating Site page, for a Complete trialImage Removed

Add/Edit Participating Site- Complete Trial

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Participating Site tab of the Add Edit Participating Site page, for an Abbreviated trialImage Removed

Add/Edit Participating Site - Abbreviated Trial

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You must abstract the Participating Site information in the order indicated by the tabbed pages.

In the drop-down lists and text fields, select or enter the appropriate information. The following table describes the fields. An asterisk (*) indicates a required field.

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Field Label

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For

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Description/Instructions

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Organization Name*

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instructions

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Local Trial Identifier*

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Enter the site trial identifier.

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Site Recruitment Status*

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  1. Optionally, to view the trial’s recruitment status history, click History.  
  2. Select the status from the drop-down list. Valid ClinicalTrials.gov recruitment values are provided in Site Recruitment Status Definitions.

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Site Recruitment Status Date*

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Enter the date that the status was recorded. The date must be the current date or earlier.

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If the lead organization or participating site is a member of a Cancer Center family of organizations, enter the accrual number.

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Date Opened for Accrual

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If applicable, enter the date that the trial was opened for accrual.

Note

You must enter a date here if you also provide a Date Closed for Approval date.

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Date Closed for Accrual

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If applicable, enter the date that the trial was closed for accrual.

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If you enter a date here you also must provide a Date Opened for Approval date. The Date Closed for Accrual can not be in the future.

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Click Save.

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Click the Investigators tab.

The Investigators tab displays the trial investigators that may have been added during trial submission or abstraction.

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Investigators tab of the Add Edit Participating Site page, for a Complete trialImage Removed

Investigators Tab for a Complete Trial

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Investigators tab of the Add Edit Participating Site page, for an Abbreviated trialImage Removed

Investigators Tab for an Abbreviated Trial

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If you want to indicate that an investigator is the primary contact, click the Set as Site Primary Contact icon next to this investigator's record.

Note

You will not be able to complete the abstraction if you do not indicate the primary contact.

Click the Contacts tab.
The Participating Sites page displays the Contacts tab.

Note

You must link a Participating Site to the trial before abstracting the site PI and contact information. You can add a contact by providing a person’s name (i.e., someone who is associated with the trial itself), or you can add a generic contact (i.e., someone who is associated with the site but not necessarily the trial) by providing a person’s title (functional role). You can not provide both types of contacts in the same record.

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In the drop-down lists and text fields, select or enter the appropriate information. The following table describes the fields. An asterisk (*) indicates a required field.

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Field Label

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Description/Instructions

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Enter the contact’s primary telephone number (as 123-456-7890), including an extension if provided.

You must provide either the contact's phone number or email address. You can provide both if the information is available.

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Email Address

 

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Type the contact’s primary email address.

You must provide either the contact's phone number or email address. You can provide both if the information is available.

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Abstracting Participating Site Information for Complete Trials

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How to Abstract Participating Site Information for Complete Trials

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Click Add. The Participating Sites page displays three tabbed sections: Participating Site, Investigators, and Contact. The Participating Sites tab is displayed by default.

Participating Site tab of the Add Edit Participating Site pageImage Removed

 

Info
titleEnter information in the Participating Site page first

You must abstract the Participating Site information in the order indicated by the tabbed pages.

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On the Participating Sites tab, next to the Organization Name field, click Look Up and follow the instructions in Searching for Organizations .
The City, State, Country, and Zip/Postal Codes fields are populated with the organization information you selected.
In the drop-down lists and text fields, select or enter the appropriate information. The following table describes the fields. An asterisk (*) indicates a required field.

Field Label

Description/Instructions

Local Trial Identifier

Enter the site trial identifier.

Site Recruitment Status*

Select the status from the drop-down list. See  Site Recruitment Status Definitions .

Site Recruitment Status Date*

Enter the recruitment status date. The date must be the current date or earlier.

Site Recruitment Status CommentsEnter one or more comments about the site recruitment status.

Target Accrual Number

If the lead organization or participating site is a member of a Cancer Center family of organizations, type the accrual number.

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, refer to the following pages:

Page Tree
rootAbstracting Participating Sites

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If you want to indicate that an investigator is the primary contact, click the Set as Site Primary Contact icon next to this investigator's record.

Note

You will not be able to complete the abstraction if you do not indicate the primary contact.

Click the Contacts tab.
The Participating Sites page displays the Contacts tab.

Note

You must link a Participating Site to the trial before abstracting the site PI and contact information. You can add a contact by providing a person’s name (i.e., someone who is associated with the trial itself), or you can add a generic contact (i.e., someone who is associated with the site but not necessarily the trial) by providing a person’s title (functional role). You can not provide both types of contacts in the same record.

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In the drop-down lists and text fields, select or enter the appropriate information. The following table describes the fields. An asterisk (*) indicates a required field.

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Field Label

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Description/Instructions

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Enter the contact’s primary telephone number (as 123-456-7890), including an extension if provided.

You must provide either the contact's phone number or email address. You can provide both if the information is available.

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Email Address

 

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Type the contact’s primary email address.

You must provide either the contact's phone number or email address. You can provide both if the information is available.

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Site Recruitment Status Definitions

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Adding Generic Participating Site Contacts

How to Add a Generic Participating Site Contact

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Next to the Generic Contact field, click Look Up Generic Contact.
The Select Generic Contact window appears.
Select Generic Contact dialog boxImage Removed

Tip

You can search for an existing generic contact. To do so, enter part or all of the generic contact's role, and then click Search.

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Abstracting Participating Site Information for Abbreviated Trials

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How to Abstract Participating Site Information for Abbreviated Trials

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Click Add. The Participating Sites page displays three tabbed sections: Participating Site, Investigators, and Contact. The Participating Sites tab is displayed by default.

Add Edit Participating Site page, for an Abbreviated trialImage Removed

In the drop-down lists and text fields, select or enter the appropriate information. The following table describes the fields. An asterisk (*) indicates a required field.

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Field Label

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Description/Instructions

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Organization Name*

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Click Look Up and follow the instructions in Searching for Organizations .

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Local Trial Identifier*

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Enter the site trial identifier.

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Site Recruitment Status*

  1. Optionally, to view the trial’s recruitment status history, click History.
  2. Select the status from the drop-down list. Valid ClinicalTrials.gov recruitment values are provided in Site Recruitment Status Definitions.

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Site Recruitment Status Date

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Enter the date that the status was recorded. The date must be the current date or earlier.

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If the lead organization or participating site is a member of a Cancer Center family of organizations, enter the accrual number.

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Date Opened for Accrual

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If applicable, enter the date that the trial was opened for accrual.

Note

You must enter a date here if you also provide a Date Closed for Approval date.

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Date Closed for Accrual

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If applicable, enter the date that the trial was closed for accrual.

Note

If you enter a date here you also must provide a Date Opened for Approval date.

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Editing and Deleting Participating Site Records

If a participating site record currently associated with the trial you are abstracting is incorrect, you can edit or delete the site.

How to Edit or Delete a Participating Site From a Trial

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To delete a participating site from the trial, in the Delete column, select the Delete check box, and then click Delete at the bottom of the list of records.

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Confirm that you want to delete the site(s) in the pop-up window.
Warning that appears when you delete a participating site record that has accrued subjectsImage Removed

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Editing and Deleting Participating Site Recruitment Status Records

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How to Edit and Delete Participating Site Recruitment Status Records

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To correct warnings/errors in a record, click the Edit icon.
The Edit Participating Site status dialog box appears.
Edit Participating Site status dialog boxImage Removed

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