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Request Upload for FDA Access
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Request aECG Source Data Upload for FDA Access

Please provide the following information to receive instructions for uploading the annotated ECG (aECG) source data files into the E-Scribe ECG Warehouse for FDA reviewer access.

The upload contact will receive all communication regarding the aECG file transfer. This person will receive e-mail notifications...

  • ... when an aECG file transfer can begin (with instructions).
  • ... if any aECG files have validation or import problems.
  • ... when the aECGs are in the E-Scribe ECG Warehouse and available for FDA review.

*************** Transition to the New ECG Warehouse ***************

FDA is testing its capability to receive annotated electrocardiogram (aECG) waveform data
in electronic format as it prepares to transition to a new warehouse for ECGs. FDA expects
that by March 2021, sponsors will submit their ECG data to the agency through the
FDA Electronic Submissions Gateway. To learn more: https://go.usa.gov/xA3wz.
Upload Contact

Name (50 char max):
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E-mail Address(es) (50 char max, separate with ';'):
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Phone Number (50 char max):
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Organization Name (50 char max):
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Organization Address (150 char max):
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FDA Application Sponsor

Same as Upload Contact:
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Name (50 char max):
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E-mail Address(es) (50 char max, separate with ';'):
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Phone Number (50 char max):
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Organization Name (50 char max):
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Organization Address (150 char max):
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Application and Study Information

Application Type:
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6-digit Application Number:
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Study Identifier (50 char max):
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FDA Contact's Name:
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FDA Contact's E-mail Address (100 char max):
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Study Protocol

Total Number Of aECG XML Files:
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Number Of Subjects:
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ECGs / AWs Per Subject:
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Time Point Measurement Method:
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Primary Analysis Lead:
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Number Of Beats Measured Per ECG / AW:
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