FDA E2B(R2) Attachment File Not Generated When Attachments Are Pdf Versions 1.3, 1.4 And 1.6 and PDF file is encrypted

(Doc ID 2364932.1)

Last updated on FEBRUARY 26, 2018

Applies to:

Oracle Argus Interchange - Version 8.1.1 and later
Information in this document applies to any platform.

Symptoms


An attachment file to be sent to the FDA does not get sent when the case has 3 pdf attachments with pdf versions 1.3, 1.4, and 1.6.
The initial ICSR received a positive ACK and the report was submitted as needed for the attachment to be generated.

The expectation is that the attachment file will be generated and get sent without regard to the pdf version as older pdf formats are still received and attached to cases.

Issue is observed in version 8.1.1

STEPS:

1) Configure a reporting destination using a copy of the 8.1.1 factory ICH-ICSR V2.1 MESSAGE TEMPLATE - FDA profile.
2) Ensure the destination allows for attachments to be sent (note the classifications selected ) and has the attachment output path configured.
3) Prepare pdf files with pdf version 1.3, 1.4, and 1.6
4) Create a case
5) Add information necessary to generate an FDA E2B file for the system
6) Add pdf files to the notes and attachments. Be sure to select an attachment classification that is configured to be sent in the reporting destination.
7) Save the case and lock the case as required for final report generation.
8) Manually Schedule an E2B report to the FDA agency created in step #1
9) Transmit the E2B file
10) Take steps to have the transmission receive a positive ACK and have the report marked as submitted
11) Monitor for the attachment in the attachment output location.
12) Observe that the attachment does not get generated as expected.



ERROR:

12-Jan-2018 12:40:36 PM: ========== Start Transmit Process ==========
12-Jan-2018 12:40:37 PM: ESM Service Login to 'cs811st' Database with UserID 'esm_login' Successfully
12-Jan-2018 12:40:37 PM: ESM Proc for AttachmentTransmission
12-Jan-2018 12:40:38 PM DEFAULT : Processing ESM_Attachment_Id - 100001, Report_Id - 1094
12-Jan-2018 12:40:38 PM DEFAULT : Error Function Merge_Attachments Error No - -2147155962, Error - AppendBookmark: PDF file is encrypted
12-Jan-2018 12:40:38 PM DEFAULT : ========== Finish Transmit Process ==========
12-Jan-2018 12:41:36 PM: ========== Start Transmit Process ==========
12-Jan-2018 12:41:37 PM: ESM Service Login to 'cs811st' Database with UserID 'esm_login' Successfully
12-Jan-2018 12:41:37 PM: ESM Proc for AttachmentTransmission
12-Jan-2018 12:41:38 PM DEFAULT : Processing ESM_Attachment_Id - 100001, Report_Id - 1094
12-Jan-2018 12:41:38 PM DEFAULT : Error Function Merge_Attachments Error No - -2147155962, Error - AppendBookmark: PDF file is encrypted
12-Jan-2018 12:41:38 PM DEFAULT : ========== Finish Transmit Process ==========

 

Cause

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