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Data storage in Pega Pharmacovigilance
Pega Pharmacovigilance uses the following solutions to hold key reference data that are used in processing adverse event cases and performing data lookups:
Local data storage
The following classes are sources for the data types that are used in the application:
| Local data storage class | Description |
|---|---|
| PegaLS-FW-AECPFW-Data-EvaluationCodes | FDA CDRH manufacturer evaluation codes |
| PegaLS-FW-AECPFW-Data-ICHCodes | ICH 2-character country codes |
| PegaLS-FW-AECPFW-Data-RouteOfAdministration | Route of drug administration, for example, oral |
| PegaLS-FW-AECPFW-Data-ProductConfiguration | Questionnaire and labeledness applicability for drugs |
| PegaLS-FW-AECPFW-Data-ProductLabelednessConfiguration | Labeledness configuration for drugs |
| PegaLS-FW-AECPFW-Data-ReporterQualification | Reporter qualifications per E2B R3 and eMDR |
| PegaLS-FW-AECPFW-Data-NullFlavorMasterList | Valid nullflavors for each attribute per entity |
MedDRA data model
The following Life Sciences Industry Foundation classes include database tables that are used in MedDRA data lookups:
| Class | Database table | Description |
|---|---|---|
| PegaLS-FW-Int-MDHIERARCHY | MD_HIERARCHY | Hierarchical path for each PT |
| PegaLS-FW-Int-HLGTHLTCOMP | HLGT_HLT_COMP | HLGT and HLT association |
| PegaLS-FW-Int-HLGTPERFTERM | HLGT_PERF_TERM | HLGTs |
| PegaLS-FW-Int-HLTPERFCOMP | HLT_PERF_COMP | HLT and PT association |
| PegaLS-FW-Int-HLTPERFTERM | HLT_PERF_TERM | HLTs |
| PegaLS-FW-Int-LOWLEVELTERM | LOW_LEVEL_TERM | LLTs and associated PTs |
| PegaLS-FW-Int-PERFTERM | PERF_TERM | PTs |
| PegaLS-FW-Int-SOCHLGTCOMP | SOC_HLGT_COMP | SOC and HLGT association |
| PegaLS-FW-Int-SOCTERM | SOC_TERM | SOC terms |
Product data model
The Product data model includes Life Sciences Industry Foundation classes and database tables that are used in WHO drug lookup and in sample drug browsing:
WHO Drug Dictionary
| Class | Database table |
|---|---|
| PegaLS-FW-Int-WHO-Drug-C-AtcCode | WHO_DRUG_C_ATC_CODE |
| PegaLS-FW-Int-WHO-Drug-C-Country | WHO_DRUG_C_COUNTRY |
| PegaLS-FW-Int-WHO-Drug-C-Ingredients | WHO_DRUG_C_INGREDIENTS |
| PegaLS-FW-Int-WHO-Drug-C-MedicinalProduct | WHO_DRUG_C_MEDICINAL_PRODUCT |
| PegaLS-FW-Int-WHO-Drug-C-Organization | WHO_DRUG_C_ORGANIZATION |
| PegaLS-FW-Int-WHO-Drug-C-PharmaForm | WHO_DRUG_C_PHARMA_FORM |
| PegaLS-FW-Int-WHO-Drug-C-PharmaProduct | WHO_DRUG_C_PHARMA_PRODUCT |
| PegaLS-FW-Int-WHO-Drug-C-ProductGroup | WHO_DRUG_C_PRODUCT_GROUP |
| PegaLS-FW-Int-WHO-Drug-C-ProductType | WHO_DRUG_C_PRODUCT_TYPE |
| PegaLS-FW-Int-WHO-Drug-C-Source | WHO_DRUG_C_SOURCE |
| PegaLS-FW-Int-WHO-Drug-C-Strength | WHO_DRUG_C_STRENGTH |
| PegaLS-FW-Int-WHO-Drug-C-Substance | WHO_DRUG_C_SUBSTANCE |
| PegaLS-FW-Int-WHO-Drug-C-TherapeuticGroup | WHO_DRUG_C_THERAPEUTIC_GROUP |
| PegaLS-FW-Int-WHO-Drug-C-Unit | WHO_DRUG_C_UNIT |
| PegaLS-FW-Int-WHO-Drug-C-UnitL | WHO_DRUG_C_UNIT_L |
| PegaLS-FW-Int-WHO-Drug-C-UnitX | WHO_DRUG_C_UNIT_X |
Internal sample products
| Class | Database table | Description |
|---|---|---|
| PegaLS-FW-Int-ProductInfo | LS_PRODUCTS | Information about the product |
| PegaLS-FW-Int-ProductType | LS_PRODUCTTYPE | Type of the product |
| PegaLS-FW-Int-ProdActiveSubstance | LS_PROD_ACTIVESUBSTANCE | Information about the active substance |
| PegaLS-FW-Int-Ingredients | LS_INGREDIENTS | The ingredients of the product |
| PegaLS-FW-Int-ATCCodes | LS_ATCCODES | List of ATC codes |
| PegaLS-FW-Int-ProdAtcCode | LS_PROD_ATCCODE | Information about products mapped to ATC codes |
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