Optimizing the Use of Data Standards

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Best Practices for Data Collection Instructions: The PhUSE Standard Analysis and Code Sharing Working Group has developed recommended displays (i.e., tables and figures) and associated code for use for analysis for data common across therapeutic areas. This project will create a white paper documenting challenges and gaps with the CDASH CRF completion as well as recommendations for a future version of CDASH. The white paper will be provided to CDISC for their consideration.

Best Practices for Metadata Documentation (Define-XML vs reviewer's guide):This project is aimed at looking at the use of the reviewer's guide in conjunction with the define.xml. The objective is to define best practices for documenting and describing dataset structures and contents within standard submission deliverables such as define.xml and the data reviewers guide, addressing common challenges, differences between reviewing agencies and divisions, and recommending quality assurance activities. The team plans on delivering at least one white paper on this subject.

CDISC Implementation Primer:(New Project): The FDA and PMDA currently require sponsors to provide study data in a CDISC format for certain types of regulatory submissions. Other global regulators such as the EMA and China FDA endorse standardising clinical trial data in a CDISC format. Additionally, academic institutions are creating or interacting with CDISC datasets during their research activities.

This project will identify needs of new CDISC implementers, with an additional focus on academia and technology providers. A "CDISC Primer" (e.g. a Wiki, White Paper, slide deck, QuickStart, guides, etc.) will be developed that addresses these needs and be made freely available to the public.

This project will be co-sponsored and co-executed with CDISC.

Clinical Legacy Data Conversion Plan Report:This team will work on a standardised approach to the development of a single traceability document to address conversions from non-standardised data (i.e. legacy) to standardised data (SEND, SDTM, ADaM). Although the Technical Conformance Guide indicates this should be added to the SDRG, FDA has agreed that a separate document is acceptable since the conversion could be related to SDTM and ADaM. There are also other traceability situations that occur within the life cycle of a compound that could be relevant and should be shared with FDA. The goals of the team are to provide a template, completion guidelines, and some examples that may be utilised by sponsors to develop the LDCP. It is expected that LDCP will be created when non-standardised data is converted to standardised data (e.g. CDISC, SDTM, SEND and ADaM).

Data Reviewers Guide in XML:This project will develop the Data Reviewer's Guide (i.e., SDRG and ADRG) in an XML format for regulatory submissions. Furthermore, this project will identify and develop style sheets, elements and semantics capability. This project will also assess a more cohesive cross-documentation data exchange between the define.xml and data reviewer's guides in an XML format. The project intends to use the existing Analysis Data Reviewer's Guide (ADRG) and Study Data Reviewers Guide (SDRG) as it's basis

Data Standards for Non-Interventional Studies:(New Project) Currently there are no strict standards and guidelines for observational studies. In this project we would like to study the challenges that programmers face during creation of the analysis datasets and handling of the data for the observational studies. The plan is to network with the programmers who have experience in observational studies and summarise the most frequent issues they have faced. The next step would be to discuss and optimise the ways they can be resolved from programming and data handling perspectives. Also data transparency should be taken into account in the discussion of dataset creation. If possible CDISC experts should be involved in the project in order to provide guidance. The results are to be presented in the form of a White Paper.

Define-XML v2.0 Completion Guidelines & Style Sheet Recommendations: This project addresses documenting the best practices in the implementation of define 2.0 and the existing style sheet. Two CDISC Define-XML liaisons are involved in this project.

Two Projects have been identified:

1) Define-XML v2.0 Completion Guidelines - The deliverable is a completion document focusing on best practices for content and granularity

2) Define-XML v2.0 Stylesheet Recommendations. This project looks to develop a define-XML v2 stylesheet for regulatory submissions and demonstrate other uses of a stylesheet, and utilise libraries and frameworks make the display more interactive 

Industry Experiences Submitting Standardised Study Data to Regulatory Authorities:(New Project): FDA and PMDA require standardised study data for certain regulatory submissions. Industry approaches to meeting these requirements vary across companies. This project provides a collaborative, non-competitive forum for industry to share submission planning, interactions with the regulators, test submissions, regulator feedback, etc. Additionally, this project will explore the development of best practices for biometrics departments to engage with regulators. Historically, biometrics departments have not directly interacted with regulators, but relied on internal regulatory affairs departments as an intermediary. The project will examine different communication use cases and make recommendations as to ensure effective exchange of information.

SDTM ADaM Implementation FAQ:Standard Implementation nuances exist across the multiple available versions of SDTM and ADaM. The project team will establish a framework for the collection, compilation, assessment, responding to, and publishing common SDTM and ADaM implementation challenges/nuances. This is important for Sponsors that are still transitioning to newer versions of standards (e.g. SDTM), as well as the vast majority who have to govern multiple versions, even for a single product or application. This is a joint project between PhUSE and CDISC. 5 primary categorical areas will be used for the FAQ's:

Have a query on SDTM / ADaM? Use this form to submit your questions.






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