SOPs, WIs, and Forms Research Informatics

1 Research Informatics1 Patrick Murphy, Research Informatics , Family Health InternationalSOPs, WIs, and FormsSOPs, WIs, and FormsResearch Informatics2 Written DocumentsWritten DocumentsStandard Operating ProceduresWork InstructionsWorkflow FormsResearch Informatics3 SOP DefinitionSOP DefinitionStandard Operating ProceduresDetailed written instructions to achieve uniformity of the performance of a specific Informatics4 Purpose and Benefits of SOPsPurpose and Benefits of SOPsInternal training materialMeet FDA regulationsOpportunity to examine and improve processesPromote consistency and efficiency on how work is performed and checked AccountabilityResearch Informatics5 Standard Operating Standard Operating ProceduresProceduresNarrow in scopeDetailed overviewRefers to other SOPs, Work Instructions, Workflow FormsSpecifies who performs tasksResearch Informatics6 SOP ManagementSOP ManagementYearly reviewControl dates, versionsApproversReviewersResearch Informatics7 FHI DM SOPsFHI DM SOPsData management planData entry system designData processing and entryData querying programmingData queryingMedical codingData set creationsData archiving libraryClintrial AdministrationMaintenance of regulated environmentResearch Informatics8 SOPs Recommended in SOPs Recommended in Recent FDA GuidanceRecent FDA GuidanceSystem setup/installationSystem operating manualValidation and functionality testingData collection and handling (including archiving, audit trails, risk assessment)System maintenanceSystem securityChange controlResearch Informatics9 SOPs Recommended (2)SOPs Recommended (2)

2 Data backup, recovery, and contingency plansAlternative recording methodsComputer user trainingRoles and responsibilities of sponsors, clinical sites, and other partiesResearch Informatics10 Sample SOPS ample SOPR esearch Informatics11 Change HistoryChange HistoryDiscontinued SOPs should be archivedChange history should be maintained on the newest SOPR esearch Informatics12 History of ChangesHistory of ChangesResearch Informatics13 Work InstructionsWork InstructionsVery detailedChanges frequentlySpecific to software packagesResearch Informatics14 Sample Work InstructionSample Work InstructionResearch Informatics15 Workflow FormsWorkflow FormsDocumentation to show control over processesResearch Informatics16 FHI Workflow FormsFHI Workflow FormsResearch Informatics17 User Access FormUser Access FormResearch Informatics18 Change Control FormChange Control FormResearch Informatics19 Batch Flow Sheet FormBatch Flow Sheet FormResearch Informatics20 SOP, WI and FormsSOP.

3 WI and FormsConclusionsConclusionsYearly reviewControl dates, versionsApproversReviewers