Table of Contents
- Title and Copyright Information
- Preface
- 1 Revision history
- 2 Introduction
- 3 Upgrade preparations
- 4 Configure the Routes of Administration flexible re-categorization codelists (NMPA Only)
- 5 Configure the Dose Formulation flexible re-categorization codelists (NMPA only)
- 6 Generate E2B(R3) reports for EMA, MFDS and NMPA
- 7 Generate E2B(R3) reports for non-standard terms
- 8 EDQM Term List Loader utility
- 9 Load an updated standard code list in a multi-tenant environment (CRO)
- 10 Add a new enterprise
- 11 Create a ZIP file with EDQM standard list
- 12 Set up a global administration account
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13
Frequently asked questions
- 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?