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The GTR Submission Process: Annual Review

OMB NO: 0925-0651

EXPIRATION DATE: 01/31/2025

Burden Statement

This document explains the Annual Review procedures and provides information to help you streamline your laboratory’s Annual Review.

Purpose of GTR Annual Review

The overall purpose of the Annual review is to meet the mutually beneficial goal of having accurate and complete data in the registry. The essential elements are to:

  1. Review and confirm the accuracy of your submitted laboratory and test information on at least an annual basis as you agreed to do when accepting the Code of Conduct.
  2. Ensure all registered tests are still offered by your laboratory.
  3. Provide more complete information on your laboratory and tests, if desired.

Thank you for your active participation in GTR.

Q & A about Annual Review procedures

TIP on finalizing the Annual Review: Making updates to your lab and test records as part of the Annual review will cause you to navigate away from the Annual Review web pages. Please remember to return to the Annual Review window and click the 'Submit' button to finalize your work. Note that confirmation emails about your laboratory submissions are not confirmations about completion of your Annual Review.

Q. Who can perform the Annual Review? A. Anyone with privileges to submit for your lab may perform the Annual Review. If you want more than one person to work on your Annual Review, you can request that we establish a Group for your lab if your lab does not have a Group yet.

Q. What are the minimal requirements for completing an Annual Review? A. The only strict requirement is that you mark all registered tests as reviewed and click to finalize the review.  Please keep in mind that by accepting the Code of Conduct you agreed ‘to uphold the integrity of the GTR through the submission of information that is accurate and not misleading’ and ‘to assure the accuracy of the data at the time of submission and to review and, if necessary, update the submitted information at least once a year’. See: http://www.ncbi.nlm.nih.gov/gtr/docs/code/.

Q. What features are available to make the process easier? A. A button to ‘Mark all as reviewed’ is available to streamline the process. Tests no longer offered can be marked for deletion. Links are available to review and edit registered tests.

Q. What other steps are recommended, but not required to complete the Annual Review? A. 1. Review your Laboratory record e.g., CLIA expiration date and staff list and update as needed. We recommend that you alert us if any staff members with submission privileges have left your lab so that we can remove their access to your submission data. 2. If applicable, evaluate test data that may not be showing publicly. 3. Complete your laboratory and test records more thoroughly.

Q. What determines my laboratory’s due date for the initial Annual Review? A. For labs with registered tests, the date of the first test submission is used. For labs with no registered GTR tests, the date the lab was last submitted is used.

Q. How will my laboratory’s due date be reset following completion of the first Annual Review? A. Completing the first Annual Review sets the next due date one year forward.

Q. Can I change the timing of my Annual Review? A. Yes. After you complete the first Annual Review the next one can be done at any time before it is due. Completion of the Annual Review resets the next due date one year forward. We designed this approach so that you are not tied in to a particular date or season for your Annual Review on an ongoing basis.

Records that are past due for Annual Review

  • Laboratory and test records that are one year beyond the last date they were edited will be marked as being past annual review. The records will continue to display in GTR.
  • Completing the Annual Review resets the date for all records and removes “out of date” marks.
  • Laboratory and test records that are two years beyond the last date they were edited will be removed from display in GTR.

Actions your laboratory can take now to streamline the process

To prepare for your annual review we recommend that you:

  • Check the CLIA and other expiration dates on your laboratory record and update these as needed.
  • Determine whether your complete test menu matches your test list in GTR. To download a complete listing of your registered GTR tests, go to your home page in the GTR submission Portal.
  • In the section 'Tests in this lab' you will be able to work on your tests (see instructions:

    • Click the 'Download tests' button to download GTR clinical test data. You will receive an email with the data in the spreadsheet submission template. You can use the spreadsheet files for submission.
    • Click on 'Manage Tests' to navigate to the test management page where you can copy, update, or delete tests, perform bulk updates using the submission wizard, and download select tests.
    • Click on 'Submit tests' to go to the submission page where you can add new tests using a the submission wizard, upload spreadsheet submission files, and access data about your API submissions.

How to access the Annual Review

The Annual Review is available from the home page for your lab in GTR Submission Portal user interface or from your submitted laboratory overview page.

  • To access the Annual Review from the submission homepage, please click the link 'Perform annual review' as shown below:

Annual review link from homepage

  • Alternatively, on the home page for your lab, click 'Review lab submission' to go to the lab record, then click 'Perform annual review' as shown below:

Annual review link from the lab overview page

GTR Support

For help with your submission, contact GTR staff.

Last updated: 2023-08-16T16:10:30Z