Starting to plan your project and understanding the GUID

 

Data Submission Agreement

As the first step in your submission project, you should download and complete the Data Submission Agreement. This document can be found below. If you intend to submit data to NDCT, this should be completed, signed by the project PI and an authorized institutional business official at the primary institution, and sent to NDAHelp@mail.nih.gov as early as possible. We expect to receive this document within 6 months of your award date. If you are unsure who at your institution is authorized to sign, please contact us and we can provide you with a list.

 

Data Submission Agreement

Last modified on Feb 23, 2018

 

When planning your project for data submission, there are a few different stages to consider. The following table displays a basic breakdown of the stages, and the primary tasks involved in each:

 

Stage

Primary Tasks

Pre-Enrollment

  • Data Submission Agreement
  • Accounting for informed consent
  • Collecting necessary participant information for GUIDs

Starting your project

  • Obtaining user accounts
  • Completing the Data Expected list
  • Understanding the NDCT Data Dictionary

Duration of project

  • Biannual cumulative data submissions

Closing your project

  • Publications and results reporting (NDA Study)
  • Data sharing regimen

 

GUID Process

The NDA provides a system, called the GUID (Global Unique Identifier) system, allowing for subjects to be identified across research labs without having any personally identifiable information (PII) being transmitted or shared.  The GUID was originally developed for the use of the National Database for Autism Research (NDAR) as a way to match data from the same participants across labs, studies, and locations, while still protecting their confidentiality. NDCT maintains a piece of software called the GUID Tool that is downloaded to your computer, and uses participant Personally Identifiable Information (PII) to create a unique identifier for that individual. If another researcher has already enrolled this participant, the tool will return that same GUID. In this way, data from that individual can be matched without PII ever leaving your local computer.  

Each lab sharing data with the NDA will need to determine if their informed consents are appropriate for use with the GUID. To help, we provide a sample plain language description, and a printable brochure  on another NDA database (NDAR) that should assist you in creating materials that will educate your participants.

NDA Sample Informed Consent Language

Last modified on Jul 6, 2017

The other project consideration relevant prior to enrollment is the collection of the subject information necessary to take advantage of the NDA’s primary de-identification tool, the GUID.  Should the informed consents not support GUID creation (see below), or the data necessasy to generate a GUID is not available, then the lab may consider using a random identifier called the Pseudo-GUID instead.  

This ability is critical to the added value of broad data sharing, so it is important to ensure that your enrollment process takes into account which information is necessary to create a GUID:

  • First name
  • Middle name
  • Last name
  • Date of birth
  • Sex
  • City/municipality of birth

In all cases, this information is needed as it appears on the birth certificate. The birth certificate is referenced as the authoritative source for all of this information, as this ensures it does not change through the individual's life. If any of this information has already changed since birth, the information should still be collected as it appears on the birth certificate.

Once a GUID has been generated for all subjects enrolled in your study, it, or the Pseudo-GUID, should be used to identify the same subject throughout your project. It will be entered as the subject identifier data element “subjectkey,” which is required in every submission file. Once a project has integrated these preparatory concepts into their plan for enrollment and data collection, NDCT user accounts can be requested and used to access the project’s Collection. We also have a video tutorial on using the tool.