RCRIM Projects: Protocol Representation and CDISC Message(s) January 2007.

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Presentation transcript:

RCRIM Projects: Protocol Representation and CDISC Message(s) January 2007

Data Collection & Mgmt Analyses & Reporting Submission Protocol Clinical Trial Tracking, Summary, Registry CDISC SDTM Study Summary (subset of CTR) CDISC Trial Design Part I (arms, elements, visits) CDISC Trial Design Part II Planned assessments & interventions (NCI Study Calendar) Structured Eligibility Criteria CDISC Statistical Analysis Plan Other Protocol Template Sections and Attachments CDISC Trial Design Part I SDTM(arms, elements, visits) CDISC Trial Design Part II SDTM Planned assessments & interventions (NCI Study Calendar) Structured Eligibility Criteria CRF Data (AE data) LAB Data Genomics Data ECG SAE Reports Analyses Report and/or Submission Preparation Report Template Content, etc CDISC Study Data Tabulation Model (SDTM) (CRF data and other, inc. SEND) CDISC ADaM (analysis datasets) Analysis Dataset Metadata CDISC Statistical Analysis Plan

Data Collection & Mgmt Analyses & Reporting Submission Protocol Clinical Trial Tracking, Summary, Registry CDISC SDTM Study Summary (subset of CTR) CDISC Trial Design Part I (arms, elements, visits) CDISC Trial Design Part II Planned assessments & interventions (NCI Study Calendar) Structured Eligibility Criteria CDISC Statistical Analysis Plan Other Protocol Template Sections and Attachments CDISC Trial Design Part I SDTM(arms, elements, visits) CDISC Trial Design Part II SDTM Planned assessments & interventions (NCI Study Calendar) Structured Eligibility Criteria CRF Data (AE data) LAB Data Genomics Data ECG SAE Reports Analyses Report and/or Submission Preparation Report Template Content, etc CDISC Study Data Tabulation Model (SDTM) (CRF data and other, inc. SEND) CDISC ADaM (analysis datasets) Analysis Dataset Metadata CDISC Statistical Analysis Plan BRIDG Terminology

Data Collection & Mgmt Analyses & Reporting Submission Protocol Clinical Trial Tracking, Summary, Registry CDISC SDTM Study Summary (subset of CTR) CDISC Trial Design Part I (arms, elements, visits) CDISC Trial Design Part II Planned assessments & interventions (NCI Study Calendar) Structured Eligibility Criteria CDISC Statistical Analysis Plan Other Protocol Template Sections and Attachments CDISC Trial Design Part I SDTM(arms, elements, visits) CDISC Trial Design Part II SDTM Planned assessments & interventions (NCI Study Calendar) Structured Eligibility Criteria CRF Data (AE data) LAB Data Genomics Data ECG SAE Reports Analyses Report and/or Submission Preparation Report Template Content, etc CDISC Study Data Tabulation Model (SDTM) (CRF data and other, inc. SEND) CDISC ADaM (analysis datasets) Analysis Dataset Metadata CDISC Statistical Analysis Plan CDISC ODM XML Schema (currently available for CRF Data in testing for TDM and CTR subset)

CDISC Standards Technical Roadmap ABCD BRIDG (Biomedical Research Integrated Domain Group) LAB ODM SDTM The CDISC Standard ODM LAB & SDTM DEFINE.XML LAB, SDTM, ODM & DEFINE.XML ADaM PROTOCOL DEFINE.XML ADaM LAB, SDTM, ODM, DEFINE.XML & ADaM CDISC harmonization milestones Terminology CDASH