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). |
Parent topic: Add attachments to your case