Submitting Data to FITBIR: A Step-by-Step Guide

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Accounts Icon
Accounts

Confirm Account Access

All data submitters must have an account to log in to FITBIR. A Data Submission Request Form must be completed and submitted for review to the Data Access Committee. Please see Get An Account for details.

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Data Repository

Create A Study

Creating a study in the Data Repository is the first step in the process to submit data. The Principal Investigator's Data Submission Request form must be attached to the study.

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Data Dictionary Icon
Data Dictionary

Compare Data To The Data Dictionary

Compare the data you are collecting against the data elements and form structures that are defined in the FITBIR Data Dictionary. Reach out to FITBIR Ops if you do not find definitions that are in alignment with your data.

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Subject Management Icon
Subject Management

Create GUIDs For Your Data

Global Unique Identifiers (GUIDs) are randomly generated alphanumeric identifiers that allow researchers to share data specific to a study participant without exposing personally identifiable information (PII). All data submitted to FITBIR must have a GUID.

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ProFoRMs

Collect Data With ProFoRMs (Optional)

If you plan on using ProFoRMs as your live data capture system, please contact FITBIR Ops for guidance on how to use this module to proactively define and capture data elements and form structures before you begin collecting data. The use of ProFoRMs is not required; you may use your own data capture system.

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Tools

Validate And Submit Data

The Data Validation tool is used to ensure data quality. The Data Submission tool writes data to your study in the Data Repository.

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Meta Study

Store And Share Data (Optional)

The Meta Study allows researchers to store and share data to meet data-sharing requirements or aggregate data from studies in the Data Repository.

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DATA SUBMISSION CRITERIA

The following criteria must be met in order to request data submission to FITBIR:

  • Data submissions must be of human clinical data.
  • Individuals requesting to submit data must:
    • Be a permanent employee of their institution at a level equivalent to, but not limited to, a tenure-track professor or senior researcher; Data Submitters cannot be post-doctoral fellows, trainees, or lab technicians.
    • Have oversight responsibility for others named on the data submission request who will be granted submission privileges to the study.
    • Can be accountable for ensuring that all aspects of data usage align with the terms of the DSA and institutional policy.
    • Have an institutional email (no public emails will be accepted, e.g., Gmail).
  • All data submission requests must be signed by an individual legally authorized to sign on behalf of the institution/business/organization.

Access may be denied or revoked if:

  • The data submission request form is incomplete.
  • The individual or affiliation cannot be confirmed.
  • The key personnel/collaborators are not from the same institution/business/organization.
  • The request comes from a country or organization that is considered hostile or a security threat.