Preferred Term Primary SOC Injury, poisoning Post procedural haemorrhage and procedural complications General disorders and administration site Chest pain conditions MedDRA Versioning MedDRA is updated twice yearly. Version contains both simple and complex “X.0” changes; version contains only simple changes. “X.1” Organisations should be aware of the types of MedDRA changes for their possible impact on data output. Types of MedDRA Changes Simple Changes Complex Changes Add a PT (new medical concept) Add or change multiaxial links Move an existing PT from one HLT to Add new grouping terms another Merge existing grouping terms Demote a PT to LLT level Restructure a SOC Add or remove a link to an existing PT Add a new SOC Add an LLT Move an existing LLT from one PT to another Promote an LLT to PT level Make a current LLT non-current or a LLT current Changing the primary SOC allocation Changes to SMQs Both simple and complex changes impact retrieval and presentation strategies. Users should read the documentation provided with each MedDRA release, especially the document. The MSSO and JMO provide tools to assist the user in comparing What’s New the changes between MedDRA versions. The Version Report (provided by the MSSO and JMO) is a spreadsheet listing all changes between the current version of MedDRA and the one previous to it; this spreadsheet is provided with each new release of MedDRA. The MSSO also provides the MedDRA Version Analysis Tool (MVAT) that facilitates identification and understanding of the impact of changes between any two MedDRA versions, including non-consecutive ones (see Appendix, Section 6.1 of this document; also, see Section 4.1.1 of the MedDRA Term Selection: Points to Consider document).
Preferred Term Primary SOC Post procedural haemorrhage Injury, poisoning and procedural complications Chest pain General disorders and administration site conditions MedDRA Versioning MedDRA is updated twice yearly. Version “X.0” contains both simple and complex changes; version “X.1” contains only simple changes. Organisations should be aware of the types of MedDRA changes for their possible impact on data output. Types of MedDRA Changes Simple Changes Complex Changes Add a PT (new medical concept) Move an existing PT from one HLT to another Demote a PT to LLT level Add or remove a link to an existing PT Add an LLT Move an existing LLT from one PT to another Promote an LLT to PT level Make a current LLT non-current or a LLT current Changing the primary SOC allocation Changes to SMQs Add or change multiaxial links Add new grouping terms Merge existing grouping terms Restructure a SOC Add a new SOC Both simple and complex changes impact retrieval and presentation strategies. Users should read the documentation provided with each MedDRA release, especially the What’s New document. The MSSO and JMO provide tools to assist the user in comparing the changes between MedDRA versions. The Version Report (provided by the MSSO and JMO) is a spreadsheet listing all changes between the current version of MedDRA and the one previous to it; this spreadsheet is provided with each new release of MedDRA. The MSSO also provides the MedDRA Version Analysis Tool (MVAT) that facilitates identification and understanding of the impact of changes between any two MedDRA versions, including non-consecutive ones (see Appendix, Section 6.1 of this document; also, see Section 4.1.1 of the MedDRA Term Selection: Points to Consider document).
000241_datretptc_r3_16_sep2018.docx