13 Frequently asked questions

This chapter contains the most frequently asked questions about the EDQM setup:

• Does the EDQM solution provided by Argus allow you to configure an EDQM term ID?
  
• What will happen to our custom codelist after upgrade?
  
• Why is the new factory data added to codelist with the display attribute unchecked?
  
• Do I need to send EDQM terminology for Dose Form and Routes of Administration since there is a provision to send free-text?
  
• Does the EDQM term ID get copied when performing a copy action for a term?
  
• If a case in E2B(R3) format is submitted to EMA and then follow-up data which requires EDQM terminology processing is received, what needs to be done from the data entry perspective?
  
• Will there be any impact on any reports submitted prior to Argus release which include the EDQM RoA and DF solution?
  
• Will there be any impact on any reports such as E2B(R2), PMDA, eVAERS, eMDR?
  
• Does EDQM publish data file containing standard term list in the form of XLS or ZIP?
  
• Does EDQM provide delta updates for standard term database changes?
  
• When FDA, PMDA and other agencies go live with EDQM, will additional configurations be required?
  
• Why does the OOTB profile send codeSystemVersion for Route of Administration and Dose Formulation, even though these are optional?
  
• What happens if the same dictionary files are loaded again using the Dictionary Management utility, EDQM option?
  
• Is there a mandate date for MFSD when you use the EDQM terminology?
  
• What is the purpose of different hierarchies (like CDF, PDF, PFT and BDF) for Dose Formulation? Do we have any guidelines to use these terms?
  
• Does Argus establish connectivity with EDQM site/system?
  
• Is there any downtime required for the system during the Load process in Dictionary Management, EDQM option?
  
• What happens if a new term is added to EDQM Standard List?
  
• What happens if an existing term from the Argus codelist is deprecated or rejected by EDQM?
  
• What happens if a non-standard term, already present in the Argus codelist, is added to the EDQM Standard dictionary?
  
• What happens if the English text is revised by EDQM for a standard term?
  
• What will happen if EDQM removes a term from the Standard List?
  
• Where can you see the EDQM Term ID in the UI for Dose Form and Routes of Administration?
  
• Can you view EDQM terms pertaining to languages other than English or Japanese?