How to submit information in the Basics section of the submission form for research tests

This page is organized according to the sections you see on the Basics tab. You can click on the name of the section below to navigate to that section of this document.

Please note that most sections in the form provide tool tips, accessible by this icon (), that provide hints specific to that area.

• Laboratory test name
• What is the purpose of the research test?
• Study related to this test
• Researchers
• Research contact policy

Test Information

Laboratory test name (minimal). Enter the name of the test as you want it to be publicly displayed in the GTR. This name will be searchable by users. 

Short test name (optional). The short test name is the shortened name or mneumonic used by the lab to identify the test.

What is the purpose of the research test (minimal). For the purposes of the GTR, a research test is defined as a test that is performed for the purpose of contributing to generalizable knowledge or for a laboratory to generate data in order to make technical improvements to a test. 'Contribute to generalizable knowledge' is applicable if the intent is to publish the study results and/or the study protocol is aproved by a research ethics committee (e.g., Institutional Review Board)

Study related to this test

Research study name (optional). Complete study name from protocol approved by research ethics committee, if applicable. Otherwise, name of study used by the laboratory.

Short study name (optional). Shortened study name one line in length to appear in lists and summaries.

ClinicalTrials.gov identifier (optional). If study is registered at www.ClinicalTrials.gov, enter Identifier in format NCT00000000.

URL for the study (optional). Enter URL to your study website, if you have one. Use prefix http:// or https:// as applicable.

If the study is approved by a research ethics committee (e.g., IRB), please provide the protocol number (recommended if the purpose of the test is to contribute to generalizeable knowledge). If the study is approved by a research ethics committee (e.g., Institutional Review Board), please provide the protocol number.

What is the study type? (optional). See ClinicalTrials.gov

Interventional - Participants are assigned to receive diagnostic, therapeutic, or other types of interventions.

Observational - Participants are assessed for biomedical or health outcomes. Interventions may be received but are not assigned as part of the study.

Expanded Access - Investigational new drugs are provided to patients with serious conditions through an FDA-regulated process.

Study description (minimal). Provide 2-3 lines of text to succinctly describe the study. Then copy/paste additional details from the study protocol, if available.

Citations for study description (optional). Please enter one citation per box and provide sufficient detail to identify the publication, e.g. J Mol Diagn 2009 11:162-71. You may enter identifiers for citations located in PubMed, PubMed Central, NCBI Bookshelf, a doi, a full citation for a book, or a website (URL). If a doi, please begin your entry with doi:, e.g. doi:1111. If a URL, please begin your entry with the protocol (e.g. http://, https://, ftp://).

Study aims and hypotheses (optional). Specify study aims and hypotheses. Copy/paste from study protocol, if available.

Upload Study protocol (optional). Upload study protocol as a pdf or word file. Do not upload proprietary information.

Researchers

Research personnel are entered in the Laboratory section of the submission site, then selected from within test submissions. For information about the required information for each of the research person type, please visit the Laboratory personnel section.

If you have not already entered the types of personnel and the minimally required information in the Laboratory section of your submission, please return to that section and enter the information there or you will not be able to submit a research test.

Person responsible for the study (minimal). Name of principal investigator or lab director who is ultimately responsible for the conduct of the research.

Study contact (minimal). Person designated as the contact to enroll in study.

Co-investigator (optional). Individual(s) involved with the Principal investigator in the scientific development or execution of the research project.

Research contact policy (optional). Description of when and how Study contact should be contacted.

Save your work

Don't forget to save your work by clicking the Save & Continue button at the bottom of the page! If you need to interrupt or delay data entry, you can return at a later time and you will be taken to the last tab you saved.

If any required fields or data inconsistencies are detected on this page, an error message will display after you click Save & Continue indicating what the issue is. The field(s) that need attention will be outlined in red. Please correct your data and click "Save & Continue" again.