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U.S. Department of Health and Human Services

Drugs

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AERS Submissions Frequently Asked Questions

  1. What Is an E2B Compliant File Format?
  2.  

    Manufacturers who wish to submit individual case safety reports (ICSRs) electronically must be capable of sending E2B or E2BM compliant SGML DTD data files as specified by International Conference on Harmonisation (ICH). General guidelines for preparing these types of files can be found at ICH-M2 ESTRI Guidelines.  

     

  3. What is the difference between E2B and E2BM?
  4.  

    E2B is the international standard for the transmittal of electronic safety data signed as an ICH Step 4 document in July1997.  E2BM clarifies and resolves issues raised in the three regional pilot studies. The revised document (E2BM) is intended to further advance the electronic exchange of safety information and approach a true EDI (Electronic Data Interchange) standard. The E2B document is implemented by M2 Specification Version 2.24 DTD Version 2.0.  The E2BM document is implemented by M2 Specification Version 2.3   DTD Version 2.1.

     

  5. How Do I Prepare E2B Compliant Files?
  6.  

    Preparing E2B compliant files to the ICH ICSR DTD specifications requires mapping your database to the E2B data set. After the database is mapped to the E2B data set, the data then must be marked in conformance with the specified DTD.

     

  7. What Does An SGML File Look Like?
  8. SGML, or Standard Generalized Markup Language, is an international standard for the description of marked-up electronic text. SGML is a meta language, which is a means of formally describing a language. More specifically, SGML is a markup language that has been used in the publishing industry to associate document format with text.

    A basic design goal of SGML was to ensure that documents encoded according to its provisions should be transportable from one hardware and software environment to another without loss of information. The structure of SGML is based on a grouping of sections and elements that are annotated by start and end tags. Tags are user-friendly phrases used to indicate the data elements contained within the tags. For example:

    <patientbirthdate>19690218</patientbirthdate>

    In this example, the starting and ending tags "patient birthdate" indicate that the data within the tags is the patient's birthdate. The relationship and order of data elements is further defined by document type definition (DTD). DTDs are document-specific specifications for the structure of an SGML document. In the following example, the DTD has specified that the order of the information be presented as:

    <patientbirthdate>19690218/patientbirthdate> <patientonsetage> 29</ patientonsetage>                  <patientonsetageunit>years </patientonsetageunit>.

    Using the above example the data must be presented in the following order to be in conformance with the DTD:

    • Patient birth date
    • Patient onset age
    • Patient onset age unit

    If the data elements are presented in any other order (e.g., patient onset age, patient onset age unit, patient birth date) the elements are not in conformance with the SGML DTD for the document.

    For electronic submission of adverse event data, a specific SGML DTD has been specified by the ICH. The ICH ICSR DTD defines the specific data elements to be included for electronic submission of adverse event data, the order of the elements, and their interrelationship.

     

  9. What Is the Most Difficult Aspect of Preparing the File?
  10. The most difficult and critical aspect of preparing the files for electronic transmission is mapping your database to the E2B or E2BM data set and developing the extract programs to build the conformant SGML file. The level of difficulty in performing these steps is dependent upon how close your current database resembles the E2B or E2BM data set.

     

  11. What Should We Expect After We Mail the Test File?
  12.  

    CDER will verify the file structure and compatibility with AERS.  If the files do not successfully load into AERS you will be notified. If the files do successfully upload into AERS, the AERS Electronic Submission Coordinator will notify you and you can begin submitting ICSRs electronically in accordance with Instructions.

  13. Should Files Include an EDI Header and Trailer?
  14. Yes, all files submitted should include the EDI header and trailer. This includes test and production files submitter via the ESTRI gateway or on physical media.  The specifications for the EDI header and trailer are in the trading partner agreement and on the FDA Gateway information page. This is an example of the use of the EDI header and trailer:

UNB+UNOB:1+000000000:01+FDAEDI.CDER:zz+000427:1100+10001’

E2B SGML goes here

‘UNZ+1+10001'