Allow free text for IMDRF and JFMDA terms

Summary

Allow free text for IMDRF and JFMDA terms (Enhancement 35634362)

Description

You can enter IMDRF and JFMDA free text in the IMDRF coding screen and JFMDA coding screen respectively, when it is selected from the following sections of the case form:

• Product > Device > Health Impact Information
• Product > Device > Evaluation / Investigation Code Information section
  • Evaluation Coding – Method / Type
  • Evaluation Coding – Result / Findings
  • Evaluation Coding – Conclusion
• Product > Device > Device component information
• Product > Device > Medical Device Problem Coding
• Event > Clinical Sign Coding

You can either select any term from standard IMDRF or JFMDA dictionary, or choose to add the free text from the coding window. This free text is then populated in the case form in the IMDRF term field or JFMDA term field.

• When free text is added in IMDRF term, the IMDRF code is appears as <not available>, only in the case form.
• When free text is added in JFMDA term, the JFMDA code is auto populated and stored with value 999-9999.

The JFMDA Code field is added to the case form English screens, to make you aware when a Japanese free text is entered in the JFMDA code field, by displaying 999-9999.

• When the JFMDA term field has free text, the global user is allowed to select a new or different IMDRF value without removing the JFMDA data.
• When the IMDRF term field has free text, the Japanese user is allowed only to enter free text.

If you select any term from the standard JFMDA dictionary that contains corresponding IMDRF code and term, then an error message is displayed that the IMDRF free text cannot be overwritten.

The JFMDA free text and the 999-9999 code are transmitted in the PMDA device XML and paper forms.