Enter additional information for the attachments

Notes and Attachments- field description

Field or Control Name Description

Notes and Attachments

Lets you sort column headers to sort the records based on the fields in the Notes and Attachment section.

Classification

Select a classification that describes the attachment. Contact your system administrator to adjust this list.

Refer to the Oracle Argus Interchange User's Guide for details about Attachment Classification usage in sending attachments in electronic reports.

Incl. Reg. Sub

Check this checkbox to merge PDF attachments within the Case Form. The Incl. Reg. checkbox identifies the attachments to be included as an appendix to Expedited reports. On checking this checkbox, the Expedited reports - CIOMS I, CIOMS I (Local), US FDA MedWatch 3500 Drug and 3500 A Device print an appendix page before each attachment. This is added to the case, and marked as Inc. Reg. Sub checked.

The checkbox is available only if a PDF is selected as an attachment.

Literature Reference

Select the Literature that is related to the attachment. Attachments that have Literature reference are transmitted as inline attachments for the data element C.4.r.2 in the E2B(R3) report.

Attach File

Inserts a file attachment into the case. Maximum file size is 4 GB.

Attach Documentum Link

This option is visible only if Documentum is available.

Click Searching for Documentum to search for and attach Documentum.

References Type

Select a reference type from the list, for example, a parent-child link. Contact your system administrator to adjust this list. For description of each reference type, see Table 2-5.

ID #

Enter the case number of the case that is to be referenced.

Click Select to search for the case that is to be referenced. You can also use this field to record the reference number for external cases.

Select

Opens the Case Selection dialog box for the selected ID.

Table 2-5 Reference types and their description

Reference Type Used in Report Description
Parent-Child Link E2B Add the parent-child link between cases.
MHRA Report Number All Add the report number of the submission made to MHRA.
EMEA Report Number All Add the report number of the submission made to EMEA.
E2B Report Duplicate E2B Add details of the duplicate E2B report.
E2B GP Medical No. E2B Add the medical number provided by the specialist.
E2B Specialist No. E2B Add the medical number provided by the general practitioner.
E2B Authority Number E2B Add the Worldwide Unique Case Identification assigned by the regulator.
E2B Company Number E2B Add the Worldwide Unique Case Identification assigned by the non-regulator.
E2B Other Number E2B Add the Worldwide Unique Case Identification assigned by the non-regulator.
E2B Linked Report E2B Add details of the linked report.
HTTP/URL Reference All Add the http or url references as part of the case.
Patient Link All Use if the multiple cases are reported in the context of same patients.
MHLW Identical Case Num All Stores case numbers of identical cases sent to MHLW.
MHLW Registration ID All Stores the Registration ID assigned by MHLW.
Local Event Number All Add the local event number that was used to create a case in Oracle Argus Safety.
MHLW Completion Report ID All Stores the Completion ID assigned by MHLW for the report sent for the case.
DEC ID All
Spanish Local Id All Add the reference number provided by the Spanish Agency on report submission.
Health Canada File Number All Add the reference number provided by Health Canada on report submission.
Source Case All Add details of the source case that was used to create the current case in Oracle Argus Safety.
PMDA Document Number PMDA Stores details of the documents received from PMDA.
EUDAMED Reference No. MIR Add the reference number as provided by EUDAMED.
Historical Ref. All Add details of the historic references related to the current case in Oracle Argus Safety.
Other NCA Local Ref. No. MIR Add the local reference number as provided by NCA.
Other EUDAMED Ref. No. MIR Add the reference number as provided by EUDAMED.
Other Mfr Ref. No. MIR Add the reference number as provided by the manufacturer.
NCA local FSCA Ref. No. MIR Add the FSCA reference number as provided by NCA.
EUDAMED FSCA Ref. No. MIR Add the FSCA reference number as provided by EUDAMED.
Mfr FSCA Ref. No. MIR Add the FSCA reference number as provided by the manufacturer.
Regulatory Ref. All Add details of the regulatory references related to the current case in Oracle Argus Safety.
E2B Hospital Record No. E2B Add the hosptial record number.
Companion Case All Add details of the companion case.
MW 3500A Mfr. Rpt. # All Add the report number of the submission made to FDA in MedWatch format.
BfArM Report Number All Add the report number of the submission made to BfArM(Germany).
PEI Report Number All Add the report number of the submission made to PEI(Germany).