Each PT is assigned one primary SOC; all other SOC assignments for that PT are called a single primary SOC prevents double counting of events when “secondary”. Having outputting data from all SOCs. All possible secondary SOC assignments for any given PT may not be present in MedDRA. However, new or revised SOC assignments can be created as a result of the change request process. 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 disorders absence of bile ducts assignment for these terms have as their primary has a primary SOC is their of “site SOC assignment assignment of SOC SOC manifestation” SOC Congenital, Congenital, familial familial and genetic and genetic disorders disorders and a secondary SOC assignment of SOC Hepatobiliary disorders Neoplastic All terms for PT Skin cancer has a Cyst and polyp terms are malignant and benign primary SOC an exception to this rule. neoplasms (except assignment of SOC The primary SOC cysts and polyps) Neoplasms benign, assignment for cyst and have as their primary malignant and polyp terms is the of “site SOC assignment unspecified (incl cysts and manifestation” SOC, SOC Neoplasms and polyps) and a the secondary SOC is benign, malignant secondary SOC SOC Neoplasms benign, and unspecified (incl assignment of SOC malignant and unspecified cysts and polyps) Skin and (incl cysts and polyps) subcutaneous tissue disorders Infectious All terms for PT Enterocolitis The secondary SOC infectious disorders infectious has a assignment for these terms have as their primary primary SOC is their of “site SOC assignment assignment of SOC SOC manifestation” SOC Infections and Infections and infestations infestations and a
Each PT is assigned one primary SOC; all other SOC assignments for that PT are called “secondary”. Having a single primary SOC prevents double counting of events when outputting data from all SOCs. All possible secondary SOC assignments for any given PT may not be present in MedDRA. However, new or revised SOC assignments can be created as a result of the change request process. 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 The secondary SOC assignment for these terms is their “site of manifestation” SOC