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Introduction

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.

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

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.

Check 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 

  1. Search for the trial of interest. In the search results, click the NCI Trial Identifier link for that trial.
  2. On the Administrative Data menu, click Participating Sites. The Participating Sites page appears.

  3. 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 page, for a Complete trial

    Add/Edit Participating Site- Complete Trial

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

    Add/Edit Participating Site - Abbreviated Trial

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

  4. 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

    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
    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.

    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. For a comprehensive matrix of valid transitions, see Trial and Participating Sites Status Transition Rules.

    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 CommentsC, AEnter one or more comments about the site recruitment status.
    Target Accrual NumberC, 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.

    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.

    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.

  5. Click Save.

  6. Click the Investigators tab.

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

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

    Investigators Tab for a Complete Trial

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

    Investigators Tab for an Abbreviated Trial

  7. Click Add and search for the investigator’s name by following the instructions in Searching for Persons .
    Lower portion of Persons search page with option to select role for investigator in Role Code column
  8. 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.
    Investigators tab, annotated to indicate the Set as Primary Contact icon
  9. 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.

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

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

    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.
    Contact tab of the Add Edit Participating Site page

  11. 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.
  12. 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

    Phone Number

     

    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.

    StatusThis field is populated by the system after you click Save.
  13. Click Save.

Abstracting Participating Site Information for Complete Trials

The system does not change the status of participating sites when you close a trial.

How to Abstract Participating Site Information for Complete Trials

  1. Search for the trial of interest. In the search results, click the NCI Trial Identifier link for that trial.
  2. On the Administrative Data menu, click Participating Sites. The Participating Sites page appears.
  3. 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 page

     

    Enter information in the Participating Site page first

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

  4. 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.

  5. Click Save.
    The organization is linked to the trial. The system sets the Status to "Pending" until verified during the curation process.
  6. Click the Investigators tab.
    The Investigators tab displays the trial investigators that may have been added during trial submission or abstraction.

    Investigators tab of the Add Edit Participating Site page
     
  7. 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.
  8. 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.

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

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

    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.
    Contact tab of the Add Edit Participating Site page

  10. 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.
  11. 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

    Phone Number

     

    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.

  12. Click Save.

Site Recruitment Status Definitions

Trial status refers to the current stage or state of participant/patient enrollment in a clinical trial relative to other stages. CTRP uses the same statuses at the trial level and at the participating site level. The following table lists the valid trial statuses used in CTRP and maps each value to the corresponding ClinicalTrials.gov-defined recruitment value. 

For information on Expanded Access trial statuses, refer to Expanded Access Statuses

 

Current trial status definitions

#

CTRP Trial Status Values

ClinicalTrials.gov Trial Status Values

Status Category

Definition

01

In Review

Not yet recruiting

Review

Participants are not yet being recruited.

11

Withdrawn

Withdrawn

Terminal

Study halted prematurely, prior to enrollment of first participant.

02

Approved

Not yet recruiting

Review

Participants are not yet being recruited.

03

Active

Recruiting

Open

Participants are currently being recruited, whether or not any participants have yet been enrolled.

04

Enrolling by Invitation

Enrolling by Invitation

Open

Participants are being (or will be) selected from a predetermined population.

08

Temporarily Closed to Accrual

Suspended

Open

Study halted prematurely but potentially will resume.

09

Temporarily Closed to Accrual and Intervention

Suspended

Open

Study halted prematurely but potentially will resume.

05

Closed to Accrual

Active, not recruiting

Closed

Study is continuing, meaning participants are receiving an intervention or being examined, but new participants are not currently being recruited or enrolled.

06

Closed to Accrual and Intervention

Active, not recruiting

Closed

Study is continuing, meaning participants are receiving an intervention or being examined, but new participants are not currently being recruited or enrolled.

10

Administratively Complete

Terminated

Terminal

Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention.

07

Complete

Completed

Terminal

The study has concluded normally; participants are no longer receiving an intervention or being examined (that is, last participant’s last visit has occurred).

Adding Generic Participating Site Contacts

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.
    Select Generic Contact dialog box

    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.
    Add Generic Contact dialog box
  3. Type the appropriate information in the Title, Email, and Phone fields, 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.

Abstracting Participating Site Information for Abbreviated Trials

How to Abstract Participating Site Information for Abbreviated Trials

  1. Search for the trial of interest. In the search results, click the NCI Trial Identifier link for that trial.
  2. On the Administrative Data menu, click Participating Sites.
    The Participating Sites page appears.
    Participating Sites page for an abbreviated trial
  3. 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 trial

  4. 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

    Organization Name*

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

    Local Trial Identifier*

    Enter the site trial identifier.

    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.

    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.

    Site Recruitment Status Date

    Enter the date that the status was recorded. 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, enter the accrual number.

    Date Opened for Accrual

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

    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.

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

  5. Click Save.

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

  1. Search for the trial of interest. In the search results, click the NCI Trial Identifier link for that trial.
  2. On the Administrative Data menu, click Participating Sites.
    The Participating Sites page appears.
  3. 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.

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

  4. 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 subjects

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

Editing and Deleting Participating Site Recruitment Status Records

The system validates participating site recruitment status transitions according to the criteria described in Abstracting Trial Status Histories.

The system validates all status transitions when you save a site 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 Site Recruitment Status History window. You can not check in the trial until you correct all status transition errors.

How to Edit and Delete Participating Site Recruitment Status Records

  1. Search for the trial of interest. In the search results, click the NCI Trial Identifier link for that trial.
  2. On the Administrative Data menu, click Participating Sites.
    The Participating Sites page appears.
  3. Click Edit.
  4. The Add/Edit Participating Site page appears.
    Participating Site tab of the Add Edit Participating Site page, annotated to indicate History button
  5. On the Add/Edit Participating Site page, click History
    The Participating Site Recruitment Status History window lists all recorded statuses for the site.
    Participating Site Recruitment Status History dialog box
  6. Optionally, to view the Audit History of a recorded status, click the View Audit Trial icon (magnifying glass).
  7. 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.
    Participating Site Recruitment Status History dialog box showing errors and warnings
  8. To correct warnings/errors in a record, click the Edit icon.
    The Edit Participating Site status dialog box appears.
    Edit Participating Site status dialog box

  9. 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.
  10. Enter comments in the field provided, and then click Save.
  11. To delete a status record, click the Delete icon, enter a comment, and then click Delete Status.

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