more than one SOC, users should be familiar with the general structure and content of all MedDRA SOCs to be sure that data are not overlooked. Example Type of Disorder Primary SOC Rule Example Comment Congenital All terms for congenital disorders have as their primary SOC assignment SOC Congenital, familial and genetic disorders PT Congenital absence of bile ducts has a primary SOC assignment of SOC Congenital, familial and genetic disorders and a secondary SOC assignment of SOC Hepatobiliary disorders The secondary SOC assignment for these terms is their “site of manifestation” SOC Neoplastic All terms for malignant and benign neoplasms (except cysts and polyps) have as their primary SOC assignment SOC Neoplasms benign, malignant and unspecified (incl cysts and polyps) PT Skin cancer has a primary SOC assignment of SOC Neoplasms benign, malignant and unspecified (incl cysts and polyps) and a secondary SOC assignment of SOC Skin and subcutaneous tissue disorders Cyst and polyp terms are an exception to this rule. The primary SOC assignment for cyst and polyp terms is the “site of manifestation” SOC, and the secondary SOC is SOC Neoplasms benign, malignant and unspecified (incl cysts and polyps) Infectious All terms for infectious disorders have as their primary SOC assignment SOC Infections and infestations PT Enterocolitis infectious has a primary SOC assignment of SOC Infections and infestations and a secondary SOC assignment of SOC Gastrointestinal disorders The secondary SOC assignment for these terms is their “site of manifestation” SOC If a PT links to more than one of these three SOCs, the following priority is used to determine the primary SOC: SOC Congenital, familial and genetic disorders SOC Neoplasms benign, malignant and unspecified (incl cysts and polyps) SOC Infections and infestations
MSSO’s Recommendations for MedDRA Implementation and Versioning for Clinical Trials Transition Date for the Next MedDRA Version Production SMQ spreadsheet* List of system tools that support SMQs * Requires user ID and password to access The following document can be found on the ICH website (): ICH E2E: Pharmacovigilance Planning Membership of the ICH Points to Consider Working Group Current members of the ICH Points to Consider Working Group Affiliation Member Commission of the European Communities Maria Luisa Casini Kavita Chadda European Federation of Pharmaceutical Industries and Associations Hilary Vass* Christina Winter† Health Canada Valérie Bergeron Lynn Macdonald Japanese Maintenance Organization Yutaka Nagao Kazuyuki Sekiguchi Mitsuru Takano Japan Pharmaceutical Manufacturers Association Yo Tanaka Hitomi Takeshita MedDRA MSSO Judy Harrison Ministry of Health, Labour and Welfare/Pharmaceuticals and Medical Devices Agency Daisuke Inoue Miki Ohta Daisuke Sato Yasuko Inokuma
Figure 5 – The alphabetical SOC order (in English) and the Internationally Agreed Order of SOCs Figure 6 – Example of a graphical display (frequency by primary SOC) Figure 7 – Example of a graphical display (frequency by primary and secondary SOC) Figure 8 – Example of a tabular display (frequency by primary SOC) Figure 9a – The upper bar of each pair represents numbers of reports from Consumers (blue) and the lower bar reports from Health Care Professionals (red) (Population 1) Figure 9b – The upper bar of each pair represents numbers of reports from Consumers (blue) and the lower bar reports from Health Care Professionals (red) (Population 2) Figure 10 – For a small dataset, a display of PTs may be adequate SOC Infections and infestations Primary SOC Analysis