Data silos challenges study setup & implementing CDISC Standards – The Glandon Suite offers the solution

Setting up a new study presents users of the CDISC standards with a number of challenges including study build, managing the transformations needed to get from collected data (CRF) to the actual SDTM/define.xml while also documenting the traceability. But help is at hand. Today the Glandon tool suite can support an effective study setup ensuring your conformance with the CDISC standards and overcome the common challenges in study build, defining SDTM and creating a define.xml:Traceability

Often the different process steps live in silos:Silos

There is no linkage to CDISC controlled terminology on the CRFs/aCRFs and annotations are being maintained manually form by form. The data collected is being loaded into an internal database and mappings are used and maintained, isolated from the annotations, i.e. often there is no linkage between the annotation and the mappings being used when creating SDTM. Consistency between the SDTM data /define.xml and the annotations needs manual review. Creating Value Level Metadata in the Define.xml is often a painful process and needs constant checking on the aCRF.

The issues described above are why we decided to develop the Glandon system. The Glandon MDR (v2.10.0) provides a standards workbench that allows curators and administrators to manage the CDISC and sponsor-defined standards. The main functionalities are:

  • Terminology for SDTM
    • User can import new CDISC terminology
    • User can manage sponsor-defined terminology
  • Definition of observations – Biomedical Concepts
    • User can create definition of something measured/observed on a patient. This is called a Biomedical Concept (BC). This definition can be reused across domains and forms ensuring consistent adherence to CDISC standard, traceability to terminology and common definition of VLMD of an observation (e.g. TEST).
  • SDTM model and SDTM IGs
    • User can import new Models and IGs from CDISC.
  • Sponsor-defined SDTM domains
    • User can create a sponsor-defined domain from SDTMIG
    • User can extend domain with additional variables (SUPP variables)
    • User can assign Biomedical Concepts to a domain indicating where an observation belongs in SDTM. Multiple domain can relate to a Biomedical Concept
  • Forms and annotations
    • User can create a form. Forms can be tagged to be either a global form, a TA specific, project specific or a study specific.
    • User can create form using ordinary questions/response or using Biomedical Concepts or a mix thereof. This is very important as we want to support existing mechanisms as used today and also improve how we work using BCs and do it incrementally.
    • User can specify if elements on form are required or optional
    • User can create CRF(pdf) and annotated CRF(pdf) by a push of a button:

Vital Signs

Annotated CRF

      • If a form is based on Biomedical Concepts, annotations on a form can be changed automatically by changing the association of the Biomedical Concept to the domain.
    • User can import forms (ALS and ODM formats) and export in ODM for sharing library of forms.
  • Impact assessment
    • Once a new CDISC terminology is imported the user can, by a push of a button, provide an overview of how the new terminology is impacting the metadata in the repository. The impact assessment will show impacted
        • CDICS terminology – impact on previous versions
        • Biomedical Concepts
        • Forms
        • Domains
  • Changes across CDISC terminology versions
    • The user can, by a simple push of a button, create an overview of the changes in terminology across version of CDISC terminology.
    • The user can by a push of a button create a display of the changes to submission values.

CDISC Terminology

QS Text

  • Changes across versions of a Form
    • The user can, by a push of a button, display differences between version of a Form.

This repository is used when creating a study setup. Using the standards will ensure consistent usage and adherence to the CDISC standards. The study workbench is a tool for specifying what to collect and report (data) for a study. This first version (Glandon Study Workbench v1.0.0) is the integrated tool of the study builder and define tool. The tool utilises the metadata from the Glandon MDR and the relationships between the metadata.

The user can do the following when specifying a study

  • Specify Schedule of Assessments (SoA)
    • The user can specify visits and Forms used on visits by adding from a list of Forms (from MDR) or create a new study specific form
    • Using a standard Form, the user can de-select/select/edit the allowable fields on the standard Form to fit the study context.
    • User can by push of a button create CRF (pdf) and aCRF (pdf) for the study.
    • User can create ALS and ODM export of the study for EDC import
    • User can create define.xml for the study
    • User can import a define.xml
    • User can export the define.xml
    • User can view and edit the auto-generated VLMD for the define.xml
    • User can modify comments and methods in define.xml
    • User can specify CDISC controlled terminology used for the study
    • User can specify the SDTM model and IG used for the study
    • User can specify version of dictionaries used in the study.
    • User can specify sponsor-defined terminology version used in the study.

With these functionalities the study setup can be done more effectively while still maintaining CDISC standards and control of the versions of the standards. The functionality removes the silos between data collection and data creation.