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	N/A
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 hospital 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).
Cross Reported IND	All	Add a reference number of the abbreviated new drug.
UF/Importer Report #	eMDR	This is the unique identifier used by the user facility or the importer for this report. For a follow-up report, the UF/Importer report number must be identical to the number assigned to the initial report.