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How to Abstract Participating Site Information 

1. Search for the trial of interest. For instructions, refer to Searching for Trials in PA.

2. In the search results, click the NCI Trial Identifier link for that trial. The Trial Identification page appears.

3. On the Trial Identification page, check out the trial. For instructions, refer to Checking In and Checking Out Trials.

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

5. Click Add.

   Anchor
   particpatingsites particpatingsites

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

   Section
   Column width 45% Add/Edit Participating Site- Complete Trial Column width 45% Add/Edit Participating Site - Abbreviated Trial

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

6. In the drop-down lists and text fields, select or enter On the Participating Site tab, in the various fields, specify the appropriate information. The following table describes the fields. An asterisk (*) indicates a required field.

   Field Label	For Complete Trials (C) For Abbreviated Trials (A)	Description/Instructions
   Organization Name*	C, A	Click Look Up and follow the instructions in Searching for Organizations . For Complete trials, the City, State, Country, and Zip/Postal Codes fields are populated with the organization information you selected.
   Local Trial Identifier*	C, A	Enter the site trial identifier.
   Site Recruitment Status*	C, A	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. Note The system validates all status transitions when you save a trial status record. If you add or update a status transition that does not conform to the rules provided in Trial Status Transitions, the system displays errors and/or warnings. Warnings indicate that fixing the status record is optional; you do not have to resolve the transitions. However, Errors indicate that you must resolve the transitions by correcting trial status records in the  Participating Sites Status History window. You can not check in the trial until you correct all status transition errors. Anchor 8518b 8518b For a comprehensive matrix of valid transitions, see Trial and Participating Sites Status Transition Rules. Anchor 8750 8750
   Site Recruitment Status Date*	C, A	Enter the date that the status was recorded. The date must be the current date or earlier.
   Site Recruitment Status Comments	C, A	Enter one or more comments about the site recruitment status.
   Target Accrual Number	C, A	If the lead organization or participating site is a member of a Cancer Center family of organizations, enter the accrual number.
   Date Opened for Accrual	A	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.
   Date Closed for Accrual	A	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. The Date Closed for Accrual can not be in the future.

7. Click Save.

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

   Section
   Column width 45% Investigators Tab for a Complete Trial Column width 45% Investigators Tab for an Abbreviated Trial

9. Click Add and search for the investigator’s name by following the instructions in Searching for Persons .
   
10. When you find the investigator in the search results list, assign the investigator role, either Principal Investigator or Sub Investigator, and then click Select.
    The person's record you selected appears on the Investigators tab.
    

11. 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.

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

    
    If you designated a primary investigator as the primary contact (on the Investigators tab), the investigator's name is displayed automatically on the Contact tab.
    Image Removed Image Added

13. On the Contact tab, next Next to the First Name field, click Look Up and search for the contact person’s name by following the instructions in Searching for Persons . The person’s name you selected appears in the Name fields on the Contact tab.

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

    Field Label	Description/Instructions
    Phone Number Anchor 6044 6044	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.
    Email Address	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.
    Status	This field is populated by the system after you click Save.

15. Click Save.

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How to Abstract Participating Site Information for Complete Trials

1. Search for the trial of interest. For instructions, refer to Searching for Trials in PA.

2. In the search results, click the NCI Trial

   Identifier link for that trial

   Identifier link for that trial. The Trial Identification page appears.

3. On the Trial Identification page, check out the trial. For instructions, refer to Checking In and Checking Out Trials.

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

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

   

    

   Info
   title Enter information in the Participating Site page first
   You must abstract the Participating Site information in the order indicated by the tabbed pages.

6. On the Participating SitesSite 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 various fields, select or enter specify the appropriate information.  The 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 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.

7. Click Save.
   The organization is linked to the trial. The system sets the Status to "Pending" until verified during the curation process.
8. Click the Investigators tab.
   The Investigators tab displays the trial investigators that may have been added during trial submission or abstraction.
   
   
    
9. Click On the Investigators tab, click Add and search for the investigator’s name by following the instructions in Searching for Persons.
   When you find the investigator in the search results list, assign the investigator role, either Principal Investigator or Sub Investigator, and then click Select.
   The person's record you selected appears on the Investigators tab.

10. 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.

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

    
    If you designated a primary investigator as the primary contact (on the Investigators tab), the investigator's name is displayed automatically on the Contact tab.
    

12. Next On the Contact tab, next to the First Name field, click Look Up and search for the contact person’s name by following the instructions in Searching for Persons . The person’s name you selected appears in the Name fields on the Contact tab.

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

    Field Label	Description/Instructions
    Phone Number Anchor 6044 6044	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.
    Email Address	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.

14. Click Save.

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How to Add a Generic Participating Site Contact

1. Next to the Generic Contact field, click Look Up Generic Contact.
   The Select Generic Contact window appears.
   

   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.

2. Click Add Generic Contact.
   The Add Generic Contact window appears.
   

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   5864 5864

   
   
3. Type In the appropriate information in the Title, Email, and Phone fields, specify the appropriate information, and then click Save.
   Your new record is displayed in the Select Generic Contact window.
4. In the Action column, click Select.
   The Participating Sites page displays the contact information you selected.
5. Click Save.

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How to Abstract Participating Site Information for Abbreviated Trials

1. Search for the trial of interest. For instructions, refer to Searching for Trials in PA.

2. In the search results, click the NCI Trial Identifier link for

   that trial

   that trial. The Trial Identification page appears.

3. On the Trial Identification page, check out the trial. For instructions, refer to Checking In and Checking Out Trials.

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

   Anchor
   participatingsite participatingsite

   

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

   

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

   Field Label	Description/Instructions
   Organization Name*	Click Look Up and follow the instructions in Searching for Organizations .
   Local Trial Identifier*	Enter the site trial identifier.
   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. Note The system validates all status transitions when you save a trial status record. If you add or update a status transition that does not conform to the rules provided in Trial Status Transitions, the system displays errors and/or warnings. Warnings indicate that fixing the status record is optional; you do not have to resolve the transitions. However, Errors indicate that you must resolve the transitions by correcting trial status records in the Participating Sites Status History window. You can not check in the trial until you correct all status transition errors. Anchor 8518c 8518c
   Site Recruitment Status Date	Enter the date that the status was recorded. 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, enter the accrual number.
   Date Opened for Accrual	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.
   Date Closed for Accrual	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.

7. Click Save.

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How to Edit or Delete a Participating Site From a Trial

1. Search for the trial of interest. For instructions, refer to Searching for Trials in PA.

2. In the search results, click the NCI Trial

   Identifier link for that trial

   Identifier link for that trial. The Trial Identification page appears.

3. On the Trial Identification page, check out the trial. For instructions, refer to Checking In and Checking Out Trials.

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

5. 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.

   Warning
   If you delete a participating site from a trial, the system deletes all of its associated accrual data. Anchor 6298 6298

6. Confirm that you want to delete the site(s) in the pop-up window.
   

7. To modify participating site's information, click the Edit icon.
8. Make changes as necessary, and then click Save.

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How to Edit and Delete Participating Site Recruitment Status Records

1. Search for the trial of interest. For instructions, refer to Searching for Trials in PA.

2. In the search results, click the NCI Trial Identifier link for that trial. The Trial Identification page appears.

3. On the Trial Identification page, check out the trial. For instructions, refer to Checking In and Checking Out Trials.

4. On the Administrative Data menu, click Participating Sites.
   The Participating Sites page appears.
5. Click Edit. The Add/Edit Participating Site page appears.
   
6. On the Add/Edit Participating Site page, click History
   . The Participating Site Recruitment Status History window lists all recorded statuses for the site.

   Anchor
   sitestatushistory sitestatushistory

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   8156 8156

   
   
7. Optionally, to view the Audit History of a recorded status, click the View Audit Trial icon (magnifying glass).
8. To validate the transitions from one status to another as they were recorded, click Validate Status Transitions.
   The system displays errors and/or warnings if any of the transitions and/or dates are invalid.
   

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

10. Select a new status from the Participating Site Status drop-down list. If the date is different from the one recorded, enter it in the Status Date field.
11. Enter comments in the field provided, and then click Save.
12. To delete a status record, click the Delete icon, enter a comment, and then click Delete Status.