Data Submission Schedule

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Data Submission Schedule

In consultation with the research community, FITBIR has established a data submission and sharing strategy to provide maximum benefit to investigators. The objective of this approach is to make data available to the research community as soon as possible without compromising the ability of the research team to interpret and present their main findings.

Data includes all research and clinical assessments and information obtained via interviews, direct observations, laboratory tasks and procedures, records reviews, genetic and genomic data, neuroimaging data, neuropsychological assessments, data from physical examinations, etc. In addition, supporting documentation that is needed to enable an investigator unfamiliar with the dataset to understand and use the data is also required. For example, supporting documentation may include non- copyrighted data collection forms, study procedures and protocols, exclusion criteria, website references, a listing of major study publications, and the definition of a genomic analysis protocols.

All data*  will be submitted to FITBIR on a quarterly basis according to the following schedule:

 
DATA COLLECTION PERIOD QUARTERLY UPLOAD DUE

January 1 - March 31

June 30

April 1 - June 30

September 30

July 1 - September 30

December 31

October 1 - December 31

March 31

 

Clinical trials are exempted from this schedule; all data from clinical trials must be submitted within a year following the end of the performance period of the award.

 

Data Sharing Schedule

Six months after submission of data, the Core (required) and Basic (recommended) TBI common data elements (CDEs) that are used in the study will be made available to all qualified and approved researchers (Data Access Account holders) as determined by the Data Access Committee (DAC). Data Access Account holders will be referred to as “Recipients”.  Other data fields can also be made available at the submitting principal investigator's (Data Submission Account holders) discretion. Data Submission Account holders will be referred to as “Submitter’s”.

Outcomes data and other data elements needed by the principal investigator to test his/her hypotheses or research questions, referred to as Experimental Data, will be made available in a staged manner. Six months after the award period ends, Experimental Data will be open to other researchers who have submitted data to FITBIR (Submitters). Twelve months after the award period ends, Experimental Data will be open to all qualified and approved researchers (Recipients).

 

Summary of the FITBIR Data Sharing Schedule

CORE AND BASIC CDES Data are uploaded quarterly after subject enrollment begins and data are available six months after submission to all approved FITBIR Data Recipients. Specific CDEs can be exempted pending approval by the Submitter’s grant funding agency if they are needed to test the primary study hypothesis or research question.
EXPERIMENTAL DATA

All approved FITBIR Data Recipients gain access either:

  1. Six months after the award period ends if they are a FITBIR Submitter; or
  2. Twelve months after the award period ends for those who are not FITBIR Submitters.

Access can also be granted earlier if agreed to by the Submitters of ongoing study(s) or in rare cases when the DAC over rules the Submitters' denial on the grounds that the request does not compromise completion of the ongoing study.

Investigators are also strongly encouraged to collaborate and share data throughout the study to accelerate research and advance knowledge on TBI.