Annex B: Cause Investigation Type of Investigation Terms and Codes – Annex C: Cause Investigation Investigation Findings Terms and Codes – Annex D: Cause Investigation Investigation Conclusion Terms and Codes – Annex E: Patient Problem Terms and Codes Annex F: Component Terms and Codes N are placeholders for Arabic numbers uniquely identifying the term with Level 1 terms populating digits 1-2 only, Level 2 terms populating digits 3 to 4 (maintaining the Level 1 parent term digits), Level 3 terms using digits 5 to 6 again maintaining the level 1 and 2 – parent term digits. Each code thus reflects the relationship to the parent / child term and the body of nomenclature it belongs to. Having two digits per level allows for changes in the future (deletion of terms / introduction of terms), which requires assignment of codes so as to new allow with existing terms/codes from previous reporting and as backward compatibility compiled in databases. Table 1: Overview of the four sets of terminologies comprising the complete terminology for adverse event reporting. No. Name of terminology Description Annex Coding system 1 Medical device problem Terms/codes for describing A A|00[00][00] problems (malfunction, deterioration of function, failure) of medical devices that have occurred in pre- or contexts (e.g. clinical studies, clinical evaluation or post-market surveillance) 2 Cause investigation Terms/codes for describing the B B|00 Type of Investigation type of investigation of the device involved in the reported event. Cause investigation Terms/codes for describing the C C|00[00][00] Investigation Findings findings of the device involved in the reported event. Cause investigation Terms/codes for describing the D D|00[00] Investigation conclusion of the device Conclusion involved in the reported event. 3 Patient Problem under development E to be E|… (to be defined) – developed 4 Component under development F to be F|… (to be defined) – developed
Annex B: Cause Investigation – Type of Investigation Terms and Codes Annex C: Cause Investigation – Investigation Findings Terms and Codes Annex D: Cause Investigation – Investigation Conclusion Terms and Codes Annex E: Patient Problem Terms and Codes Annex F: Component Terms and Codes N are placeholders for Arabic numbers uniquely identifying the term with Level 1 terms populating digits 1-2 only, Level 2 terms populating digits 3 to 4 (maintaining the Level 1 parent term digits), Level 3 terms using digits 5 to 6 – again maintaining the level 1 and 2 parent term digits. Each code thus reflects the relationship to the parent / child term and the body of nomenclature it belongs to. Having two digits per level allows for changes in the future (deletion of terms / introduction of terms), which requires assignment of new codes so as to allow backward compatibility with existing terms/codes from previous reporting and as compiled in databases. Table 1: Overview of the four sets of terminologies comprising the complete terminology for adverse event reporting. No. Name of terminology Description Annex Coding system 1 Medical device problem Terms/codes for describing problems (malfunction, deterioration of function, failure) of medical devices that have occurred in pre- or contexts (e.g. clinical studies, clinical evaluation or post-market surveillance) A A|00[00][00] 2 Cause investigation Type of Investigation Terms/codes for describing the type of investigation of the device involved in the reported event. B B|00 Cause investigation Investigation Findings Terms/codes for describing the findings of the device involved in the reported event. C C|00[00][00] Cause investigation Investigation Conclusion Terms/codes for describing the conclusion of the device involved in the reported event. D D|00[00] 3 Patient Problem under development E – to be developed E|… (to be defined) 4 Component under development F – to be developed F|… (to be defined)
imdrf-tech-170921-aer-n43-r2.docx