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| == Overview == | | == Overview == |
| The Medical Device and Clinical Compliance (MDCCD) Data Warehouse is an Oracle 19c based data warehouse maintained by Shared Services Canada (SSC) and Health Canada's (HC) Digital Transformation Branch (DTB). | | The Medical Device and Clinical Compliance (MDCCD) Data Warehouse is an Oracle 19c based data warehouse maintained by Shared Services Canada (SSC) and Health Canada's (HC) Digital Transformation Branch (DTB). |
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| + | The MDCCD Data Warehouse uses a concept called "Fundamental Datasets". Fundamental Datasets are meant to be a standardized dataset that is optimized for |
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| == Problems to Address == | | == Problems to Address == |
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| === '''Table Naming Convention''' === | | === '''Table Naming Convention''' === |
− | Tables are named using a | + | Tables are named using a 3 or 4 code convention. |
| + | |
| + | * PROGRAM |
| + | ** This two letter code indicates the MDCCD program that the table applies to. |
| + | *** MD - Medical Device |
| + | *** AH - Assisted Human Reproduction |
| + | *** BD - Blood |
| + | *** CO - Cells, Tissues, Organs |
| + | *** CT - Clinical Trials |
| + | * FUNCTION |
| + | ** This two to three letter code indicates the functional area of the program. |
| + | *** INS - Inspection |
| + | *** EST - Establishment Licence |
| + | *** COM - Company |
| + | *** INC - Incident |
| + | *** REC - Recall |
| + | * TABLE GROUP |
| + | ** This code indicates if the table is part of a larger grouping of tables that hold common information. |
| + | ** CASE - Case Information |
| + | ** IRC - Inspection Report Card Information |
| + | * TABLE |
| + | ** This code indicates the name of the table. |
| + | |
| + | The convention follows the following formats |
| + | |
| + | * 3 Code: [PROGRAM]_[FUNCTION]_[TABLE] |
| + | ** Example: MD_INS_CASE (Medical Device Inspections, Case Table.) |
| + | * 4 Code: [PROGRAM]_[FUNCTION]_[TABLE GROUP]_[TABLE] |
| + | ** Example: MD_INS_CASE_CAPA (Medical Device Inspections, Case Table Grouping, Corrective Action Plan Table.) |
| + | |
| + | === Table Listing by Schema & Program === |
| + | |
| + | ==== MDCCD_DM_OWNER ==== |
| + | {| class="wikitable" |
| + | |+Medical Devices |
| + | !Table Name |
| + | !Table Description |
| + | |- |
| + | |MD_INS_CASE |
| + | |This table is the main medical device inspection table. |
| + | |- |
| + | |MD_INS_CASE_CAPA |
| + | |This table holds information about the corrective action plan for an inspection observation. |
| + | |- |
| + | |MD_INS_CASE_DESIGNATION |
| + | |This table holds designation codes for an inspection. |
| + | |- |
| + | |MD_INS_CASE_ESTACTIVITY |
| + | |This table holds the activities of the establishment as entered by the inspector. |
| + | |- |
| + | |MD_INS_CASE_INSPECTORS |
| + | |This table holds a list of inspectors working on the inspection. |
| + | |- |
| + | |MD_INS_CASE_NOTES |
| + | |This table holds the notes for an inspection. |
| + | |- |
| + | |MD_INS_CASE_OBSERVATIONS |
| + | |This table holds the observations for an inspection. |
| + | |- |
| + | |MD_INS_CASE_WORKFLOW |
| + | |This table holds the busienss process flow (workflow) for an inspection. |
| + | |- |
| + | |MD_INS_IID |
| + | |This table holds the ''Initial Inspection Deficiency'' information for an inspection. |
| + | |- |
| + | |MD_INS_INSPECTORLIST |
| + | |This table holds a list of inspectors in the MDID system. |
| + | |- |
| + | |MD_INS_IRC_ENFORCEMENT |
| + | |This table holds the enforcement actions listed for an inspection as part of the ''Inspection Report Card''. |
| + | |- |
| + | |MD_INS_IRC_MEASURES |
| + | |This table holds the measures listed for an inspection as part of the ''Inspection Report Card''. |
| + | |- |
| + | |MD_INS_IRC_OBSERVATIONS |
| + | |This table holds the observations listed for an inspection as part of the ''Inspection Report Card''. |
| + | |- |
| + | |MD_INS_SITE |
| + | |This table holds the listing of sites from the MDID system including those migrated from the Medical Device System (MDS). |
| + | |- |
| + | |MD_INS_SITE_CONTACT |
| + | |This table holds the listing of site contacts from the MDID system including those migrated from the Medical Device System (MDS). |
| + | |- |
| + | |MD_INS_SITE_LICENCE |
| + | |This table holds the listing of site establishment licences from the MDID system including those migrated from the Medical Device System (MDS). |
| + | |- |
| + | |MD_INS_SITE_LICENCEACTIVITY |
| + | |This table holds the listing of site establishment licence activities from the MDID system including those migrated from the Medical Device System (MDS). |
| + | |} |
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| == Contacts == | | == Contacts == |