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

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When splitting this multi-section page into smaller pages, consolidate all viewing tasks into one child page, and then clarify that these tasks do not require checkout. Consider doing the same throughout the PA guide.


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. (This checkout step is optional for Super Abstractors.)

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

  5. Click Add.

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

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

    Add/Edit Participating Site- Complete Trial

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

    Add/Edit Participating Site - Abbreviated Trial

    Note

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

  6. 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
    1. Optionally, to view the trial’s recruitment status history, click History.  
    2. Select the status from the drop-down list. Valid For valid ClinicalTrials.gov recruitment values are provided in Site Recruitment Status Definitions, refer to Trial Status Values in the CTRP and ClinicalTrials.gov and Expanded Access Statuses.
    For a comprehensive matrix of valid transitions, see Trial and Participating Sites Status Transition Rules.8750 

    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.

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    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

    AIf 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.

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

    Investigators Tab for a Complete Trial

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

    Investigators Tab for an Abbreviated Trial

  9. 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
  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.
    Investigators tab, annotated to indicate the Set as Primary Contact icon
  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 Contact tab. The Participating Sites page displays the 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.
    Contact tab of the Add Edit Participating Site page

  13. 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.
  14. In the various fields, specify the appropriate information. The following table describes the fields. An asterisk (*) indicates a required field.

    6044

     


    Field Label

    Description/Instructions

    Phone Number

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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.

    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.
  15. Click Save.

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