Product quality issue and medication error. The mother administered an If underdose is reported Product dropper calibration underdose of antibiotic in the context of a unreadable because the lines on the medication error, the Accidental underdose dropper were illegible more specific LLT Accidental underdose can be selected. APPENDIX Versioning Versioning methodologies Each organisation should have a versioning strategy that should be documented. The versioning strategy may differ between safety databases and clinical trial databases. For example, there may be no need to update clinical trial data from older trials if the data are not presently used or will not be used in the future. On the other hand, postmarketing safety data may be required to be reported in the current (or near-current) version of MedDRA, and version update recommendations then apply. Users should choose the most optimal approach based on their organisation’s characteristics. The optional methods described below can be used to document the extent to which an organisation has applied a new version of MedDRA. These methods should not be interpreted as regulatory requirements but may be used to communicate effectively between and within organisations. The table below summarises the types of versioning methods. Resource Data Method Description Intensity Accuracy 1 Begin to use new version for coding new data; no Least Least recoding of existing data 2 Identify verbatim terms linked to non-current LLTs and ↓ ↓ recode existing data 3 Identify verbatim terms linked to non-current LLTs and recode existing data and Recode verbatim terms to new LLTs that are direct or lexical matches
The mother administered an underdose of antibiotic because the lines on the dropper were illegible Product dropper calibration unreadable Accidental underdose Product quality issue and medication error. If underdose is reported in the context of a medication error, the more specific LLT Accidental underdose can be selected. APPENDIX Versioning Versioning methodologies Each organisation should have a versioning strategy that should be documented. The versioning strategy may differ between safety databases and clinical trial databases. For example, there may be no need to update clinical trial data from older trials if the data are not presently used or will not be used in the future. On the other hand, postmarketing safety data may be required to be reported in the current (or near-current) version of MedDRA, and version update recommendations then apply. Users should choose the most optimal approach based on their organisation’s characteristics. The optional methods described below can be used to document the extent to which an organisation has applied a new version of MedDRA. These methods should not be interpreted as regulatory requirements but may be used to communicate effectively between and within organisations. The table below summarises the types of versioning methods. Method Description Resource Intensity Data Accuracy 1 Begin to use new version for coding new data; no recoding of existing data Least Least 2 Identify verbatim terms linked to non-current LLTs and recode existing data ↓ ↓ 3 Identify verbatim terms linked to non-current LLTs and recode existing data and Recode verbatim terms to new LLTs that are direct or lexical matches