Primary SOC assignment rules Primary SOC assignment rules are described in the MedDRA Introductory Guide. These rules affect the way terms are placed in MedDRA and determine their data display by SOC. Because these rules allow for terms related to a particular medical condition to be in 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 PT Congenital The secondary SOC congenital absence of bile assignment for these has a primary disorders have as ducts terms is their of “site their primary SOC SOC assignment of SOC manifestation” assignment SOC SOC Congenital, Congenital, familial familial and genetic and genetic disorders and a disorders secondary SOC assignment of SOC Hepatobiliary disorders PT has Neoplastic All terms for Skin cancer Cyst and polyp terms malignant and a primary SOC are an exception to this benign neoplasms assignment of SOC rule. The primary SOC (except cysts and Neoplasms benign, assignment for cyst and polyps) have as malignant and polyp terms is the “site their primary SOC unspecified (incl of manifestation” SOC, assignment SOC cysts and polyps) and the secondary SOC is SOC Neoplasms benign, and a secondary Neoplasms malignant and SOC assignment of benign, malignant and unspecified (incl SOC Skin and unspecified (incl cysts cysts and polyps) subcutaneous tissue and polyps) disorders Infectious All terms for PT Enterocolitis The secondary SOC infectious disorders infectious has a assignment for these have as their primary SOC terms is their of “site primary SOC assignment of SOC SOC manifestation” assignment SOC Infections and Infections and infestations and a infestations secondary SOC assignment of SOC Gastrointestinal disorders If a PT links to more than one of these three SOCs, the following priority is used to determine the primary SOC:
Primary SOC assignment rules Primary SOC assignment rules are described in the MedDRA Introductory Guide. These rules affect the way terms are placed in MedDRA and determine their data display by SOC. Because these rules allow for terms related to a particular medical condition to be in 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:
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