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Comment: Added checkout step & clarified adjacent instructions.

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  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 Scientific Data menu, click Markers. The Markers page appears. It displays any markers that may have been recorded previously. 
    Markers page

  5. Click Add.
    The Add Marker page appears.
    Add Marker page with marker attributes for selection

  6. Search for and select the biomarker from the caDSR by following the instructions in Searching for Biomarkers in caDSR.

     

    Tip
    titleYou can enter a biomarker name directly

    If you cannot find the biomarker indicated in the protocol document in caDSR, click Cancel to return to the Markers page, and enter the biomarker name directly in the Name field.

     

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  7. Select the appropriate attributes. The following table describes the fields. An asterisk (*) indicates a required field.

    Info

    You can select multiple attributes for Evaluation Type, Assay Type, Biomarker Purpose, and Specimen Type.

    If you select Other as an attribute for Evaluation Type, Assay Type or Specimen Type, you must enter text in the Evaluation Type Other Text , Assay Type Other Text or Specimen Other Text fields respectively.

    Trial Description

    Instruction

    Name*

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    Click caDSR and follow the instructions in Searching for Biomarkers in caDSR. If you cannot find the biomarker indicated in the protocol document in caDSR, enter the biomarker name directly in the Name field to create a placeholder value.

    Evaluation Type*

    Select the type of evaluation. Valid values include:

    Include Page
    Marker Evaluation Types - Include v4.4
    Marker Evaluation Types - Include v4.4

    Note
    titleSpecial instructions for "Other" text

    If you select "Other," copy and paste the exact name of the evaluation (as written in the protocol) into the Evaluation Type Other Text box. 

    Assay Type* (CDE ID 64731)

    Select the test type(s), the test name(s), or method(s) used to assess a specific marker. Valid values include:

    Include Page
    Marker Assay Types - Include v4.4
    Marker Assay Types - Include v4.4

    Note
    titleSpecial instructions for "Other" text

    If you select "Other," copy and paste the exact name of the assay/method (as written in the protocol) into the Assay Type Other Text box. 

    Biomarker Use* (CDE ID 2939411)

    Select the value that describes the assay use. Valid values include:

    Include Page
    Marker Assay Use - Include v4.4
    Marker Assay Use - Include v4.4

    Biomarker Purpose* (CDE ID 2939397)

    Select the value(s) that describes the reason or intention of the assay in the clinical study. Valid values include:

    Include Page
    Marker Purpose - Include v4.4
    Marker Purpose - Include v4.4

    Specimen Type* (CDE ID 3111302)

    Select the type(s) of sample. Valid values include:

    Include Page
    Marker Specimen Type - Include v4.4
    Marker Specimen Type - Include v4.4

    Note
    titleSpecial instructions for "Other" text

    If you select "Other," copy and paste the exact name of the specimen (as written in the protocol) into the Assay Type Other Text box. 

    Record Status

    This field is populated by the PA system. When you save the biomarker information, the system sets the marker status to one of the following:

    • Pending - Indicates that a request for a new permissible value has been submitted

      Footnote

      The Pending status changes to Accepted once the Research Scientist enters corresponding Public ID  in the Pending Markers Report. For information about updating the status of a marker, see Processing New Marker Requests.

    • Active - Indicates that the marker was listed in caDSR

    Footnotes Display

  8. Do one of the following to save the record:
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How to Search for Markers in caDSR

  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 Scientific Data menu, click Markers. The Markers page appears.

  5. Click Add. The Add Marker page appears.
  6. Follow the initial steps in Adding Biomarkers, until the Markers page appears.
  7. Next to the Name field, click caDSR. The Marker Search in caDSR window appears.
    Marker Search in caDSR dialog box with search term

  8. Enter all or part of the criteria for the search in the fields provided.

  9. To restrict your search by case, next to Case-Sensitive Search, select Yes (the default is case-insensitive).

  10. To highlight the term you searched for in the list of results, next to Highlight Query Text, select Yes.

  11. Press the ENTER key on your keyboard, or click Search.

  12. The results of your search are listed in a table with their permissible values

    Footnote

    The TSR document associated with a trial includes both the permissible value and alternates (synonyms).

    .

  13. In the row that contains the appropriate marker, click Select.
    You are returned to the Add Marker page. The Marker Name field is populated with information from the marker you selected.

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How to Request Markers from HUGO for Addition to the caDSR Database

  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 Scientific Data menu, click Markers. The Markers page appears.

  5. Click Add. The Add Marker Follow the initial steps in Adding Biomarkers, until the Markers page appears.
  6. Next to the Name field, click caDSR. The Marker Search in caDSR window appears.
    Marker Search in caDSR dialog box
  7. Click Create Biomarker Request.
    The Create Permissible Value Request window appears, with your email address in the Sender's Email address field.
    Create Permissible Value Request section of Marker Search in caDSR dialog box
  8. Select the Found in HUGO? check box, and then click the HUGO link.
    The window displays a new field for the HUGO marker code, and the HGNC database is launched in a new browser window.
  9. Search for the marker in the HGNC database, and then enter the HGNC ID number for the appropriate record into the Hugo Marker Code field. This field is displayed only when you select the Found in HUGO? check box.
  10. In the Text of marker as written in the protocol field, copy and paste, or enter, the information about the marker as it appears in the protocol.
  11. Click Send Email.
    Your request is sent to the caDSR for processing. The value you requested is listed on the Pending Markers Report with the Pending status. You can return to the Pending Markers report later to enter the Public ID number once caDSR has sent notification to the Research Scientist that the new term was created. (See Processing New Biomarker Requests.)

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How to Edit Marker 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. (This checkout step is optional for Super Abstractors.)

  4. On the Scientific Data menu, click Markers. The

    Follow the initial steps in Adding Biomarkers, until the

    Markers page appears.
    Markers page annotated to indicate featuresImage Modified

  5. To edit a marker, in the Edit column, click the Edit (pencil) icon.
    The Edit Marker page appears.
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    Top portion of the Edit Marker page
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  6. Follow the instructions for selecting and saving attributes in Adding Biomarkers to change the recorded information.

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How to Delete Marker 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. (This checkout step is optional for Super Abstractors.)

  4. On the Scientific Data menu, click Markers. The

    Follow the initial steps in Adding Biomarkers, until the

    Markers page appears.

  5. Do one of the following to select the markers you want to delete:
    1. To delete a marker(s), select the check box in the Delete column for the appropriate marker record(s). You can select multiple records.
      - or -
    2. To delete all markers, click Select All.
      The button changes to Deselect All.
  6. Optionally, to clear all check boxes, click Deselect All.
  7. Click Delete, and then confirm that you want to delete the record.

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How to Request New Permissible Values for Biomarkers

  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 Scientific Data menu, click Markers. The Markers page appears.

  5. Click Add. The Add Marker Follow the initial steps in Adding Biomarkers, until the Markers page appears.
  6. Next to the Name field, click caDSR. The Marker Search in caDSR window appears.

  7. Click Create Biomarker Request.

    The Create Permissible Value Request window appears, with your email address in the Sender's Email address field.

    Create Permissible Value Request section of Marker Search in caDSR dialog box
  8. In the Marker Name field, enter the most appropriate biomarker name followed by the name as it appears in the protocol in parenthesis if the two are not identical.
  9. In the Text of marker as written in the protocol field, copy and paste, or type, the information about the marker as it appears in the protocol.
    Click Send Email.
    Your request is sent to the caDSR for processing. The value you requested is listed on the Pending Markers Report with the Pending status. You can return to the trial later to accept it once it has been processed. (See Processing New Biomarker Requests.)

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