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Frequently Asked Questions
ECG Warehouse


Answers

ECG Warehouse
  1. What is the E-Scribe ECG Warehouse?
    The E-Scribe ECG Warehouse was developed in collaboration with the United States Food and Drug Administration (FDA) (see original announcement at
    Mortara Instrument Announces Collaboration with US Food and Drug Administration (FDA)). This warehouse acts as a repository for annotated electrocardiograms (aECGs) collected during the study of drug effects in humans.  FDA reviewers use the system to archive and review aECG data provided with drug applications (e.g. NDA, BLA, IND, IDE, etc.). The E-Scribe ECG Warehouse provides FDA reviewers with advanced, state-of-the-art analysis and review tools from Mortara's E-Scribe Rx product and VERITAS™ ECG algorithms.

  2. Who Can Upload ECG Data into the ECG Warehouse?
    Any organization can initiate a transfer of annotated ECG data in support of their drug application. To initiate the transfer, information about contact persons and the FDA application must be provided using the Request Upload for FDA Access form found at:
    Request Upload for FDA Access

  3. How early can aECGs be loaded before releasing to the FDA?

    aECGs cannot be loaded into the ECG Warehouse before the sponsor is ready for FDA reviewers to see the data.  There is no way to temporarily store aECGs in the ECG Warehouse and give an independent authorization to release the aECGs to the FDA.  Uploads taking longer than 30 days will be canceled by ECG Warehouse administrators.  Arrangements can be made to use the ECG Warehouse tools and storage features by sending an inquiry to info@ecgwarehouse.com.



  4. Who Can Access aECG Data Contained in the ECG Warehouse?
    Only FDA reviewers are allowed access to aECG data provided in support of drug applications.  Organizations providing aECG data to the FDA can make arrangements with Mortara to validate and view their own data prior, during, and/or after FDA review. Organizations can also make arrangements to validate, warehouse and analyze aECG data sets independent of FDA reviews. Send inquiries to
    info@ecgwarehouse.com.

  5. What Tools are Contained Within in the ECG Warehouse?
    Mortara Instrument provides fee-based access to the E-Scribe ECG Warehouse to sponsors interested in utilizing it prior to submitting a new drug application for regulatory review. In addition to data warehousing, sponsors can elect to use the E-Scribe ECG Warehouse tools for dataset import and format validation; web-based query; and review of ECG data and VERITAS™ algorithmic scoring for rank ordering ECG records of interest.

  6. How can I get more information about the ECG Warehouse?
    Please e-mail all inquiries to
    info@ecgwarehouse.com.


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