E2B Elements Reference

This is always set to “1” for ICH ICSR.

This value is a concatenation of the Site for the Subject (ISO two letter code), the unique identifier for your EDC system (unique to all Studies in that vault), the vault’s ID, the object record’s ID, a dash (“-“), and the numeric value for the Nth message of the case (for example, “US-VAULTCDMS-110377V6800000000L003-1”). The EDC system identifier has “TEST” appended to it when in non-production environments. For the message number, “0” is the first send, “1” is the first follow up, and so on.

This is the Batch Sender Identifier specified in the study’s Transmission Profile. This matches up with the sender profile configured in the safety system.

This is the Batch Receiver Identifier specified in the study’s Transmission Profile. This matches up with the receiver profile configured in the safety system.

The full date and time (in UTC) of when Vault creates the Safety Message and its XML file.

This is the same as “N.1.2”.

This is the same as “N.1.2”.

This is the same as “N.1.2”.

This is the same as “N.1.5”.

This value is a concatenation of the Site for the Subject (ISO two letter code), the unique identifier for your EDC system (unique to all Studies in that vault), the vault’s ID, and the object record’s ID (for example, “US-VAULTCDMS-110377V6800000000L003”). The EDC system identifier has “TEST” appended to it when in non-production environments.

Vault creates the Safety Message right before transmitting it. This field captures the date of creation to the second. It acts as a message identifier.

This is set to “2” for “Report from Study”.

This field captures the date and time when all required fields (Items) are captured for an SAE.

Indicates the first change made on a given date by a data entry user involving data in the safety case, after the last safety message was sent. For example, if on the same date a user first changes data on a Medical History form at 8 AM, then changes data on the SAE form at 10 AM, and finally links two Concomitant Medication forms at 11 AM, with all changes made to data in the same safety case, the C.1.5 value will be 8 AM on that date in the next scheduled transfer.

This is the same as “C.1.1”.

This is always set to “2” for “Other”.

If the Message Type is “Amendment”, Vault sets this field to “2”. If the Message Type is “Nullification”, Vault sets this field to “1”.

If the field is null, this isn’t included.

If the field is null, this isn’t included.

This is the Name of the study’s Organization (in EDC, the sender).

This is the study’s name/label.

This is always set to “1”, for “Clinical Trials”.

2 character country code for the site’s Study Country

“MedDRA” is removed from the string. This field is only sent once it is Coded or Autocoded, because there’s no place for the Medical History Term in the E2B, only the coded values.