Quality Assurance (QA) Procedures

Data is uploaded to the NDA using the Validation and Upload Tool. First, it identifies all of your files to determine which data structure they should be checked against. It then validates and assist you in harmonizing the data within each file to be consistent with the standard data structure for this measure. Once all files conform to the standard, the tool packages and uploads the data to NDA.

Once all errors are resolved and warnings are ignored or resolved, you will be able to build an upload package. Provide it with a title and description that will help you reference it later; titles and descriptions are for internal use only. Select your NDA Collection from the dropdown menu. Most users will have only one. Once the package is built, you can view the zip archive and XML manifests in your user/NDA Submission folder. This can be selected later using the File > Open submission package for upload option in the tool's File menu, to pick up an interrupted upload where it left off if necessary.

Once your submission is completed successfully, you should review it in the Submissions Tab of your NDA Collection.

Quality Assurance (QA)/Quality Control (QC)

If the Validation Tool encounters an error or the upload fails, it will save an error file in the upload package folder to assist in troubleshooting. During each submission cycle, the data uploaded cumulatively are run through a set of automated quality checks NDA has developed, and you’ll be given the opportunity to correct any detected issues that were logged in the error file. Post submission, Quality Assurance and Quality Control (QA/QC) checks are run across records ensuring basic information is accurate. Results of these checks are then collated by NDA Collection and emailed to those that submitted the data, typically data managers, so that any issues found may be fixed prior to the next scheduled submission. The email provides a link to a report containing Summary and Detailed QA/QC issues.

Those with Admin access to the NDA Collection, may filter and download records identified by the QA report as having errors by navigating to the Collection Submissions Tab and selecting the "Submissions with QA Errors" radio button to see if any submissions contain errors.

The goal of QA/QC and Data Harmonization during the Validation and Upload of your data is to resolve any issues as soon as possible helping ensure that data are accurate. Feel free to contact us if you require additional information or assistance in resolving these outstanding issues (NDAHelp@mail.nih.gov).

Quality Assurance (QA) Notifications

After each submission cycle, NDA conducts a variety of QA procedures on submitted data. These processes check for things like GUIDs that appear to be associated with more than one individual, impossible changes in age based on dates, or other possible discrepancies in entered data. You may receive an email notification within 4 months after a submission outlining any issues detected. The notifications will include instructions on resolving the issue, and this may sometimes involve additional steps, but in many cases, it is preferred to simply correct any issue in the next cumulative upload. Please be aware of these notices and the steps to resolve the issues in order to prevent the sharing of data containing such errors.

Additionally, as your project continues, the data you collect will be submitted regularly and checked using NDA's QA processes. The following slides will cover the tasks related to the ongoing process of collecting, harmonizing, uploading, and responding to QA reports throughout the lifespan of your project. Please remember that your data is shared according to the dates indicated in the Data Expected List of your NDA Collection, and in accordance with the terms of your project's award.

Quality Assurance Tutorial