This document is an overview of the methods by which information can be registered in the GTR.  Detailed information is provided in specific pages, as summarized below.  The table of contents expedites navigation to the section of interest.

Table of Contents

1. What constitutes a test in the GTR?
2. What types of tests are currently accepted?
3. What data should be collected before submitting?
4. How do I get started?
5. Who is authorized to submit?
6. Overview of the steps
7. List of the steps, with links to detailed information about each step
8. Submission scenarios
9. Conventions used in the interactive submission interface
10. Your submission site

What constitutes a test in the GTR?

A test in the GTR is defined as the equivalent of an order code. The definition of a genetic test in the GTR may be found here.

What types of tests are currently accepted?

GTR is now accepting registration of clinical tests for Mendelian disorders, complex tests and arrays, and pharmacogenetic tests. These tests may include multiple methods and may include multiple major method categories such as biochemical, cytogenetic, and molecular tests.

Some of your information in GeneTests is represented as a laboratory service. Those which are truly services (i.e. general and not disease specific) will be processed in the laboratory record. Those which are truly tests or testing methods will not be migrated, so each can be registered as a fully-described test.

GTR is not currently accepting registration of tests for somatic disorders, research tests or direct-to-consumer tests.  To receive notification when this status is changed, please consider subscribing to our GTR News RSS feed.

Tests which are performed entirely at an outside lab/facility (send-outs) should not be registered in GTR. 'Outside' means a lab/facility that is not covered by your lab's CLIA certification, even if both labs have the same parent organization.

What data should be collected before submitting?

The list of data elements that may be submitted is provided in GTR's Data Dictionary (pdf or Word). These elements are categorized as minimal, recommended, and optional. Minimal fields are required, and submission will fail if not supplied. Recommended elements are not required, and can be skipped in the submission process. The web interface will, however, report 'not provided'.

For laboratories currently registered in GeneTests, most of the minimal data elements are already available electronically and can be copied from GeneTests to the GTR. While the GTR and GeneTests sites are both available, you may find it useful to consider timing the migration of your data to the GTR to follow immediately after you update your information in GeneTests. That way, the updates you wish to make public will be available in both resources, and will be transferred without duplicate data entry in the GTR.

Migration is not sufficient to achieve the minimal requirements of the GTR. Some supplementary data are required. In the Laboratory section, the minimal fields Facility phone number and email address may need to be entered depending on whether your lab previously submitted these data to GeneTests. The following fields must be completed to migrate and register a test:

1. Laboratory test name (as you want it to be publicly displayed in the GTR)
2. Purpose of the test (indications selected from these choices: Diagnosis, Drug response, Mutation confirmation, Pre-implantation genetic diagnosis, Risk assessment, Screening)
3. Primary test methodology (name of the test method used in the assay, e.g. Oligonucleotide Ligation Assay (OLA), Enzymatic levels)
4. Target identified by and Name of target (Analyte, chromosomal region, gene, or protein; and specific name of the target such as a gene or enzyme name)
5. Analytical validity (Accuracy and reliability of the test for measuring the component of interest)

Registration in GTR is divided into two major categories:

1. Laboratory and personnel data (entered once for all tests)
2. Test-specific information, where a test is defined as the equivalent of an order code.

How do I get started?

The GTR help site includes multiple documents about registering laboratories and tests, with some specific and distinctive aspects of the submission/update process. The tabs at the top of the page provide menus from which to select the page specific to your topic of choice.  Details about each tab are provided in the table below.

Laboratory information must be entered first. Test information for your laboratory can be entered only after the laboratory has been registered in the GTR.

Who is authorized to submit?

At the moment, only one person per lab can submit lab and test data to GTR. You may choose whom to designate in your lab to submit to GTR, and that person will need a MyNCBI account.

If your lab will be migrating data from GeneTests, the same individual will need to be authorized to login to GeneTests. The GeneTests login is distinct from the MyNCBI account and they are not linked to each other.

Overview of the steps

1. Login
2. If your laboratory participates in the GeneTests Laboratory Directory, you can transfer information from GeneTests to GTR about both your laboratory and each of the tests you offer by a process termed migration.  You can then review the content, add more details about your laboratory and your tests interactively, and submit your data.
3. If you are not registered in GeneTests, you can create a record about your laboratory, and we will contact you about the next steps.
4. If you have many tests to register, there are several options to update in a bulk mode.

List of the steps, with links to detailed information about each step

To enter a new laboratory, go to the submission interface and click the Add a new lab button. Once you submit your lab, you will receive an email informing you your information was submitted. GTR staff will review the information and they must approve your lab before you can register your tests. This may take 2-3 business days and we may contact the lab if more information is needed. When your lab is approved, you will receive a notification email informing you that you can register your tests.

Submission scenarios

1. Completely interactive: The submitter reviews lab information and test information via web-based forms to complete the registration process and/or update existing records.
2. Semi-automatic: (Available by June, 2012)
   1. The submitter reviews lab information interactively, downloads a spreadsheet template, completes that spreadsheet for each test the lab offers and uploads the result. GTR integrates that information with information in GeneTests, and returns results with questions for the submitter to review.
   2. The submitter reviews lab information interactively, downloads a spreadsheet template  which supports entry of a subset of required elements, and completes that spreadsheet for each test the lab offers. Test data are not migrated from GeneTests, and the submitter uses the submission interface to complete each record.
3. Completely automatic. The submitter registers the laboratory, and then uploads an XML file containing complete information for a laboratory and the tests it offers.