Attachments in Reports

Case Form Attachments are sent to Reporting Destination with the E2B (R2) report as described below:

1. If attachment classification in the case is specified in the Reporting Destination, system reads such Attachments and converts .XLS, .TXT, .TIF, .DOC, .RTF, .PNG, .JPG or .BMP them into PDF and combine with the PDF attachments if any in the case.
2. The single merged PDF has each attachment which is merged available as a link (bookmark) by the classification name provided for the attached file.
3. Attachments are sent only if there is a E2B report sent out for that Agency. Attachments are not sent for nullification reports.

Note:

While transmitting attachments using the FDA profile in the E2B (R2) format, the system places the attachment file (PDF file created by merging all relevant attachments) in the configured Attachment folder (Reporting Destination > EDI tab > ICSR Attachment Outgoing folder) only after receiving a positive ACK for the ICSR submitted in the E2B (R2) format as an Initial or Follow-up report.

The placement of Attachment files in configured folder after receipt of Positive Ack is done only for E2B (R2) generated using FDA E2B (R2) profile (CFG_PROFILE.AUTHORITY_ID=2.

The system retains the ICSR Attachment in the Outgoing folder if a negative acknowledge is received for an ICSR.

Case Form Attachments are sent to the Reporting Destination with E2B (R3) report as described below:

1. Case Form Attachments are embedded within the ICSR sent in report formats such as E2B (R3), eVAERS and eMDR.
2. Attachments are encoded in the B64 format and sent in the report. The selection of attachments is based on Reporting Destination configuration.
3. Attachments for E2B(R3) are compressed using the compression algorithm configured before embedding them to ICSR. The default algorithm used is DF (Deflate). Attachments are not compressed in eVAERS and eMDR reports.
4. Attachments that were sent out in previous submissions are not sent in Follow-up submission of E2B (R3), eVAERS and eMDR reports (only new and updated attachments are sent in Follow-up reports).

   Note:

   Case Attachments are not sent along with the MIR Report.