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- Do you currently have a fixed data reporting period for your Providers or is there flexibility for the Providers to determine the timeframe for the data that they are submitting? For example, do Providers have the ability to report on either an academic year or a calendar year?
- When do you require your Providers to report data to you?
- When Providers report data to you for a given reporting period, do you ask them to attest to the accuracy/completeness of the data? (We’re trying to understand whether your Providers are able to report data on an ongoing basis. For instance, for an enduring activity, would the Provider be able to report data in the middle of the reporting year and provide up-to-date data about that activity at the end of the reporting year?)
- From the time your Providers report REMS data to you, how long would it take you to turn it around to the third-party CE data aggregator (Polaris)?
- The FDA asks that we report data current through May 10th of each year, but accreditation timelines vary. Would you be able to receive data more current than your accreditation timeline requires? For example, if your timeline requires that Providers submit data for the previous reporting year in March, would you be willing to receive REMS-CE data one additional time per year from your Providers and submit it for aggregation with other Accreditors’ data in time for the July 9 FDA report? If yes, what would be a reasonable timeline for that additional report?