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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. |
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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.
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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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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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- Optionally, to view the trial’s recruitment status history, click History.
- 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.
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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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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.
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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.
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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.
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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 |
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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 Comments | Enter 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:
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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.
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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.
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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.
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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.
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*
- Optionally, to view the trial’s recruitment status history, click History.
- 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.
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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. |
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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.
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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.
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