NSDRG Introduction - PhUSE



Study Data Reviewer’s GuideNonclinical(nSDRG)STUDY TITLE <Study ID>SPONSOR NAMESPONSOR ADDRESSCONTENTS TOC \o "1-3" \h \z STUDY TITLE <Study ID> PAGEREF _Toc477640637 \h 11.nSDRG Introduction PAGEREF _Toc477640638 \h 31.1Study Protocol Title, Number and Report Version PAGEREF _Toc477640639 \h 31.2Summary of SEND Dataset Creation Process PAGEREF _Toc477640640 \h 31.3SEND Dataset Verification PAGEREF _Toc477640641 \h 32.Study Design PAGEREF _Toc477640642 \h 32.1Study Design Summary PAGEREF _Toc477640643 \h 32.2Trial Design Domain Overview PAGEREF _Toc477640644 \h 33.Standards, Formats, and Terminologies and their Versions PAGEREF _Toc477640645 \h 43.1Standards Used PAGEREF _Toc477640646 \h 43.2Rationale for Standards Selection PAGEREF _Toc477640647 \h 43.3Nonstandard Terminology PAGEREF _Toc477640648 \h 44.Description of Study Datasets PAGEREF _Toc477640649 \h 44.1Dataset Summary PAGEREF _Toc477640650 \h 44.2Dataset Explanation PAGEREF _Toc477640651 \h 54.2.1EX-Exposure PAGEREF _Toc477640652 \h 54.3Use of Supplemental Qualifiers PAGEREF _Toc477640653 \h 55.Data Standards Validation Rules, Versions, and Conformance Issues PAGEREF _Toc477640654 \h 55.1Validation Outcome Summary PAGEREF _Toc477640655 \h 55.2FDA SEND Validation Rules Version PAGEREF _Toc477640656 \h 55.3Errors PAGEREF _Toc477640657 \h 55.4Warnings PAGEREF _Toc477640658 \h 66.Sponsor Decisions Related to Data Standards Implementations PAGEREF _Toc477640659 \h 66.1Sponsor Defined Standardization Descriptions PAGEREF _Toc477640660 \h 66.2Differences between SEND Datasets and Study Report PAGEREF _Toc477640661 \h 66.3Nonstandard Electronic Data Submitted PAGEREF _Toc477640662 \h 66.4Legacy Data Conversion PAGEREF _Toc477640663 \h 6nSDRG IntroductionStudy Protocol Title, Number and Report VersionStudy TitleStudy NumberReport VersionSummary of SEND Dataset Creation ProcessSEND Dataset VerificationStudy DesignStudy Design Summary(text here, if needed)Number of AnimalsGroupTreatmentDoseLevelDose ConcentrationDoseVolumeMainTKTerminalRecoveryMainmg/kg/daymg/mLmL/kgMaleFemaleMaleFemaleMaleFemaleTrial Design Domain OverviewThe following diagram illustrates the trial design. (note: table format is dependent on trial design; add or delete rows as needed.)Study GroupTrial ArmsElement in each EpochTrial SetSPGRPCDARMCDARM<EPOCH name 1><EPOCH name 2><EPOCH name 3>SETCDSET<Sponsors group no.><Set name 1><Set name 2><Set name 3>Standards, Formats, and Terminologies and their VersionsStandards UsedStandard or DictionaryStandard or DictionaryVersions UsedTabulation DatasetsCDISC SEND Implementation GuideControlled TerminologyCDISC SEND Controlled TerminologyData Definition fileCDISC DEFINERationale for Standards SelectionThe standards versions used were the most current at the time of dataset creation.Nonstandard TerminologyThe following nonstandard terminology was used:Dataset NameVariableCodelistTerm UsedMeaningDescription of Study DatasetsDataset SummaryDataset NameDataset LabelSupplemental Qualifiers?Related Records?Observation ClassTSTrial SummarySpecial PurposeTETrial ElementsSpecial PurposeTATrial ArmsSpecial PurposeTXTrial SetsSpecial PurposeCOCommentsSpecial PurposeDM DemographicsSpecial PurposeSE Subject ElementsSpecial PurposeEXExposureInterventionsDSDispositionEventsBWBody WeightFindingsBG Body Weight GainFindingsCLClinical ObservationsFindingsDDDeath DiagnosisFindingsEGECG Test ResultsFindingsFWFood and Water ConsumptionFindingsLBLaboratory Test ResultsFindingsMAMacroscopic FindingsFindingsMI Microscopic FindingsFindingsOM Organ MeasurementsFindingsPMPalpable MassesFindingsPC Pharmacokinetics ConcentrationsFindingsPP Pharmacokinetics ParametersFindingsSCSubject CharacteristicsFindingsTFTumor FindingsFindingsVSVital SignsFindingsPOOLDEFPooled DefinitionSpecial PurposeDataset ExplanationEX-Exposure (EX domain is an example. Text or table here for further description per data set, as needed)Use of Supplemental QualifiersDataset NameAssociated DatasetQualifiers UsedData Standards Validation Rules, Versions, and Conformance IssuesValidation Outcome Summary(text here)FDA SEND Validation Rules VersionRule conformance to SEND 3.0 was evaluated using xxxxx version N.x, which includes checks for conformance against the FDA Specific SEND Validation Rules, Version Y.x.Errors(text here)WarningsThe following warnings were reported:Rule MessageDomain(s)CountExplanationSponsor Decisions Related to Data Standards ImplementationsSponsor Defined Standardization DescriptionsDifferences between SEND Datasets and Study ReportNonstandard Electronic Data SubmittedLegacy Data Conversion ................
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