Quality Checks are performed on submitted datasets to FITBIR at the end of a study and on an annual basis.
End of Study Closeout Reports
End of Study closeout reports are performed by FITBIR Operations at the conclusion of the study and once the study team submits their data to FITBIR. It is a systematic process that applies specific validation analysis to ensure the quality of the data that was submitted to FITBIR.
Annual Study Closeout Reports
Annual closeout reports are an important mechanism that FITBIR Operations performs to ensure data quality matches FITBIR standards. This allows FITBIR Operations to identify and address any key errors or issues in the study team's early submission, so that subsequent submission will not have to be modified at the end of the study. For investigators, this ensures that the first and subsequent data submissions are of high quality and accurately reflect the data the team has collected and intends to submit to FITBIR.
If errors and issues are identified earlier in the process of submission, that will reduce the burden at the end of the study. Moreover, data managers may leave the team after the study has ended and having to address issues found in the final closeout report may be more difficult for new staff who haven’t yet been trained on FITBIR and are unaware of the study team’s submission history.
Study Closeout Validation Analysis
Study closeout validation analysis aims to identify duplicative data, missing data, partial data, incorrectly calculated data, and incorrectly labeled data before data is shared with the FITBIR community. For imaging data, additional spot analysis is performed to check for PII on the imaging headers and image quality. This study closeout process provides a systematic approach each time a study is eligible for closeout.
Currently the study closeout report provides the following information to study teams:
Each Study Closeout Report Package includes: