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    CD Ash

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    khannamca
    The document provides an overview of the CDASH (Clinical Data Acquisition Standards Harmonization) project and version 1.0 of the CDASH standard. It describes the background and goals of developing content standards for clinical trial data collection. Version 1.0 of the CDASH standard is organized into sections and includes domain tables with recommendations for collecting various types of data like adverse events, ECG results, physical examinations, and disposition. Next steps discussed are developing training programs, collecting feedback, and updating the standard.

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    CD Ash

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    khannamca
    69 views26 pages
    The document provides an overview of the CDASH (Clinical Data Acquisition Standards Harmonization) project and version 1.0 of the CDASH standard. It describes the background and goals of developing content standards for clinical trial data collection. Version 1.0 of the CDASH standard is organized into sections and includes domain tables with recommendations for collecting various types of data like adverse events, ECG results, physical examinations, and disposition. Next steps discussed are developing training programs, collecting feedback, and updating the standard.

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    The document provides an overview of the CDASH (Clinical Data Acquisition Standards Harmonization) project and version 1.0 of the CDASH standard. It describes the background and goals of developing content standards for clinical trial data collection. Version 1.0 of the CDASH standard is organized into sections and includes domain tables with recommendations for collecting various types of data like adverse events, ECG results, physical examinations, and disposition. Next steps discussed are developing training programs, collecting feedback, and updating the standard.

    Copyright:

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    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    69 views26 pages

    CD Ash

    Uploaded by

    khannamca
    The document provides an overview of the CDASH (Clinical Data Acquisition Standards Harmonization) project and version 1.0 of the CDASH standard. It describes the background and goals of developing content standards for clinical trial data collection. Version 1.0 of the CDASH standard is organized into sections and includes domain tables with recommendations for collecting various types of data like adverse events, ECG results, physical examinations, and disposition. Next steps discussed are developing training programs, collecting feedback, and updating the standard.

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    Standard CRF: the CDASH project

    CDISC Italian-Speaking User Group Meeting 6 March 2009 Isabella Montagna, LifeBee

    Outline Background CDASH Standard version 1.0


    - Overview - CDASH Alignement with other CDISC Standards - Best Practice Recommendations - CDASH Domain Tables
    Adverse Events ECG Physical Examination Disposition

    Next Steps
    2

    Background
    CDASH is classified as an opportunity of the FDA Critical Path Initiative.
    Opportunity #44 Development of Data Standards
    Currently, clinical investigators, clinical study personnel, data managers and FDA reviewers must cope with a plethora of data formats and conventions Lack of standardization is not only inefficient, it multiplies the potential of error

    Opportunity #45 - Consensus on Standards for Case Report Forms


    Clinical trial data collection, analysis, and submission can be inefficient and unnecessarily expensive. Standardization of the look and feel of case report forms could reduce these inefficiencies and also help accelerate progress toward electronic data capture and submission.

    Background
    Project goals
    Develop a set of content standards for the clinical trials data collection Limit variables to required and necessary data Be consistent with regulatory requirements Allow efficient data collectionection/storage/transmission/analysis Be focused on CRF content, not CRF layout

    Background
    2005 - Effort initiated by ACRO

    2006 - Project led by CDISC

    2006 Formation of Collaborative Group


    (Pharma, Biotech, CROs, Universities, )

    2007 Packages Development

    2008 CDASH Standard Version 1.0 Publication


    5

    CDASH Standard Version 1.0


    Release Date: 1st October 2008 Organization of the document
    Section 1: Orientation Section 2: CDASH Alignment with Other Standards Section 3: Best Practice Recomendations Section 4: Overview of CDASH Domain Tables Section 5: CDASH Domain Tables Section 6: Change Control and the Process for Creating New Domains Section 7: Appendices
    http://www.cdisc.org/standards/cdash/downloads/CDASH_STD-1_0_2008-10-01.pdf

    CDASH Standard Version 1.0


    Orientation
    The aim of the Clinical Data Acquisition Standards Harmonization (CDASH) Standard Version 1.0 is to describe recommended basic standards for the collection of clinical trial data. Highly Recommended data collection variables should always be present on the CRF, however, it is assumed that Sponsors will add data collection variables as needed to meet protocol specific and other data collection requirements. It is strongly recommended that standards are defined at the sponsor level taking into consideration the requirements of the stage of clinical development and therapeutic area requirements, and NOT on a trial-by-trial basis within the sponsor organization.

    CDASH Standard Version 1.0


    CDASH Alignment with Other CDISC Standards CDASH SDTM

    All SDTMIG Required variables have been discussed and either included in the CDASH standard, determined to be derivable or can be obtained from data sources other than the CRF. CDASH includes some data collection fields that are not included in the SDTMIG (e.g., Were there any adverse events? or Were any concomitant medications taken?). These collection fields are intended to assist in the data cleaning and in confirming that no data are missing.

    CDASH Standard Version 1.0


    CDASH Alignment with Other CDISC Standards CDASH SDTM

    AE Relatedness to Study Drug? Company 1 No Unlikely Possible Probably Definite Company 2 Not Related Doubtful Possible Probable Very Likely Company 3 NO YES / Unknown CDASH No Unlikely Possible Probably Definite SDTM No Unlikely Possible Probably Definite

    CDASH Standard Version 1.0


    Best Practice Recomendations
    Recommended Methodologies for Creating Data Collection Instruments Suggested CRF Development Workflow FAQs about Best Practices for Creating Data Collection Instruments.

    10

    CDASH Standard Version 1.0


    Best Practice Recomendations
    Necessary Data Only
    CRFs should avoid collecting redundant data and should instead Focus on collecting only the data needed to answer the protocol questions and to provide adequate safety data. The process of designing, printing, distributing CRFs, and accounting for unused CRFs must be controlled by SOPs. The review should involve CRF designers, statisticians, Clinical Operations staff, scientific experts, Regulatory experts, Data Entry, Pharmacovigilance. The team developing the data collection instruments needs to consider the workflow at the site and the standard of care. Data need to be collected in a way that doesnt introduce bias or errors into the study data.

    Control Adequate Review

    Site Workflow Clarity

    11

    CDASH Standard Version 1.0


    Best Practice Recomendations
    Translations
    CRFs that are translated into other languages should follow the same development process as the original CRF.

    CRF Completion Guidelines

    Putting short instructions and prompts on the CRF increases the probability that they will be read and followed and can reduce the number of queries and the overall data cleaning costs.

    Employ Standards

    CDASH standards should be used wherever possible and sponsor standards developed as needed.

    12

    CDASH Standard Version 1.0


    Best Practice Recomendations

    13

    CDASH Standard Version 1.0


    CDASH Domain Tables

    1. Basic data to be collected 2. Suggested variable name (SDTM-like variable) 3. Purpose of data collection field (example, code list if available) 4. Information on how to enter data 5. Additional Information for Sponsors: rationale and implementation instructions 6. CDASH Core: Highly Recommended, Optional, Recommended/Conditional
    14

    CDASH Standard Version 1.0


    CDASH Domain Tables
    - Adverse Events (AE) - Comments (CO) - Prior and Conc. Medications (CM) - Demographics (DM) - Disposition (DS) - Drug Accountability (DA) - ECG Test Results (EG) - Exposure (EX) - In/Ex Criteria (IE) - Laboratory Test Results (LB) - Medical History (MH) - Physical Examination (PE) - Protocol Deviations (DV) - Subject Characteristics (SC) - Substance Use (SU) - Vital Signs (VS)

    15

    CDASH Standard Version 1.0


    Adverse Events
    Highly Recommended Adverse Event Term Serious Event Start Date End/Stop Date AE Severity Relationship Action Taken Outcome Recommended/Conditional Start Time End/Stop Time Relationship Type
    16

    Optional Were any AE Experienced? AE Sequence Number Category/Sub Category for AE Event Pattern Code Event Body Location Serious Event Type Ongoing/ Continuing Other Action Taken

    CDASH Standard Version 1.0

    Adverse Events

    17

    CDASH Standard Version 1.0

    Adverse Events

    18

    CDASH Standard Version 1.0

    Adverse Events

    19

    CDASH Standard Version 1.0


    ECG
    Scenario 1: Central reading: ECG results are captured directly by an electronic device and transmitted separately or read centrally not recorded on the CRF.

    Highly Recommended Date of ECG ECG Status

    Recommended/Conditional Time of ECG Time Point Internal or external reference num. Subject Position

    20

    CDASH Standard Version 1.0


    ECG
    Scenario 2: Local reading: When results of ECG are reported directly on the CRF

    Highly Recommended Date of ECG Test Name Test Result ECG Status

    Recommended/Conditional Time of ECG Time Point Clinical Significance Units Subject Position Evaluator Reason Not Done

    21

    CDASH Standard Version 1.0


    ECG
    Scenario 3: Central processing but CRF includes site assessment of clinical significance

    Highly Recommended Date of ECG Test Name ECG Status Clinical Significance

    Recommended/Conditional Test Result Vendor Name Time of ECG Time Point Protocol defined testing conditions met ECG Reference ID

    22

    CDASH Standard Version 1.0


    Physical Examination
    Best Practice Approach
    Different from the traditional approach and recommended by the team as best practice. 1. Use of a PE form only to record whether or not the exam was performed, and if so, the date of the examination. 2. Sites are instructed to record baseline abnormalities on medical history form, targeted medical history form or baseline conditions form. 3. Sites are instructed to record any post baseline abnormalities or baseline conditions that worsened post baseline on the Adverse Event (AE) form.

    Optional Overall Examination Status (was exam done?) Date of Examination (if done) Time of Examination

    23

    CDASH Standard Version 1.0


    Physical Examination
    Traditional Approach
    1. Use of a PE form at baseline and post baseline visits. 2. Use of a PE form at baseline, but not at post baseline visits. Sites are instructed to record any post baseline abnormalities or baseline conditions that worsened post baseline on the Adverse Event (AE) form.

    Recommended/Conditional Date of Examination Body System Examined Examination Result Abnormal Findings

    Optional Sponsor Defined Identifier Time of Examination Overall Examination Status Evaluator

    24

    CDASH Standard Version 1.0


    Disposition
    Highly Recommended Subject Status Recommended/Conditional Trial Epoch Date of Completion or Discontinuation Optional Will the subject continue? Next trial epoch or new trial subject will be entering Was treatment unblinded by the site?

    25

    Next Steps
    Development & implement CDASH training program. Present the CDASH standards at conferences, webinars, user group meetings etc. Collect feedback from Early Implementers Update CDASH v. 1.0 as required CDASH New SDTM Domains as required

    26

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