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Requests for new permissible values are listed in the Pending Markers Report. The CTRP system designates these permissible values as Pending until you accept them. Once you accept a permissible value, the CTRP system changes its status from Pending to Accepted and drops all instances of it from the Pending Markers Report.

Info

It may take several days for the caDSR to process your request.

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Accepting Requested Permissible Values - Include v4.4

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All new permissible value requests are listed in the Pending Markers Report with the CTRP Status Pending. You can sort the list of markers by CTRP ID, Marker name, and Term Request date. Each permissible value requested via the Create Biomarker Request feature during trial abstraction is displayed in the report with the request date/time. Term Request Forms are provided for permissible values entered manually (i.e. typed in rather than selected as a result of a search in caDSR) during trial abstraction. Once requested, the link to the form is replaced by the request date/time.

Footnote

The systems does not display requests for values associated with trials that have been rejected.


How to Accept Pending Marker Requests

  1. On the main menu, click New Marker Requests.
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    The Pending Markers Report displays all new requests for permissible values, listed by request date.
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    Pending Request Report showing search fields at the top of the page, and the list of pending markers
  2. Do one of the following to locate the request of interest:
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    • Sort the list by clicking the CTRP ID, Marker Name, or Term Request column. Click the column header(s) a second time to reverse the sort order.
      or
    • Search for the marker by its associated CTRP Trial ID. Enter all or part of the ID, and then click Search.
      or
    • Search for the marker by its name. Enter all or part of the Marker Name, and then click Search.
    Info

    Allow enough time for the caDSR to process the request, and then search for the value in caDSR. For instructions, see Searching for Biomarkers in caDSR.

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    Your search may not return a marker name under the following circumstances:

    • caDSR changed the value you requested due to an error (such as spelling), and added the corrected marker name to their records.
    • There is no exact match in the caDSR database for the requested value you searched for. The system displays a message if this occurs.

    Before you accept any value, check the spelling of the requested value, or search for part of the marker name instead,

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  3. Optionally, to assist you with determining the correct value, download/view the Protocol document associated with a report by clicking the Document icon (The Document icon, which is a graphic representation of a page of text) in the CTRP ID column.
  4. Click caDSR Search.
    The Marker Search in caDSR displays marker search options. For instructions, see Searching for Biomarkers in caDSR.
    Marker Search in caDSR dialog box, with search fields and results

  5. Enter the search term and then click Search.

  6. If the correct marker name (as per the Protocol document) appears in the caDSR database, copy the Public ID and return to the Pending Markers Report.

  7. Paste or enter the Public ID into the caDSR Public ID field, and then click Accept.
    The value you selected is displayed for final approval.

    Marker Search in caDSR dialog box, requesting your confirmation

  8. To accept the term, click Proceed with the Change.
    The value is accepted and removed from the Pending Markers Report.
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  9. To send a request to caDSR for terms entered manually during trial abstraction, on the Pending Markers Report, click Term Request Form.
    The form is pre-populated with the term requested.
    Create Permissible Value Request dialog box, annotated to indicate the term requested

  10. Enter the text of the marker, and then click Send Email.
    The system displays the date and time of your request and removes the Term Request Form.

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Editing Requested Permissible Values

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If caDSR changed the name of the requested value when adding it to the database, change the name of the originally-requested value accordingly.

How to Edit Pending Marker Requests

  1. On the main menu, click New Marker Requests.
    The Pending Markers Report displays all new permissible value requests.
  2. To change the name of a new permissible value, click Edit.
    The Edit Marker Name page displays the current requested marker name, and the Trial Identifier for which the new permissible value was requested.
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  3. Change the name to match the caDSR value, and then click Save.
    The value is accepted and removed from the Pending Marker Report.

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