Optimizing the Use of Data Standards

Over the last decade there has been a significant development and adoption of data standards, showing a promising improvement in the delivery of data to support drug product and device submissions, as well as the review process. However, there have also been gaps, issues and challenges in the interpretation and use of data standards. This Working Group aims to identify and close specific gaps that prevent the FDA and industry from optimising the use of data standards.

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Best Practices for Data Collection Instructions 

The PhUSE Standard Analyses & 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.

 

 

 

 

CDISC Implementation Primer 

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 or guide) will be developed that addresses these needs and which will be made freely available to the public.

This project is being co-sponsored and co-executed by CDISC.

Clinical Legacy Data Conversion Plan Report

This team is working 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, the 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 the 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 the LDCP will be created when non-standardised data is converted to standardised data (e.g. CDISC, SDTM, SEND and ADaM).

 

Data Reviewer's Guide in XML

This project is developing the Data Reviewer's Guide (i.e. SDRG and ADRG) in an XML format for regulatory submissions and, furthermore, is identifying and developing style sheets, elements and semantics capability. It is also assessing 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 Reviewer's Guide (SDRG) as its basis.

SDSP-XML

As conducted with the DRG-XML project (still ongoing), to develop a machine readable version of the Study Data Standardization Plan (SDSP) as XML. The deliverable for this project is to provide a prototype SDSP-XML package (i.e., sdsp.xml, sdsp.xsl, sdsp schema, and overview guide).

Data Standards for Non-interventional Studies

Currently, there are no strict standards and guidelines for observational studies. This project studies 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 will be to discuss and optimise the ways they can be resolved from programming and data handling perspectives. 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 v2.0 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 focussed on best practices for content and granularity

2) Define-XML v2.0 Style Sheet Recommendations. This project looks to develop a Define-XML v2.0 style sheet for regulatory submissions and demonstrate other uses of a style sheet, utilising libraries and frameworks to make the display more interactive.

Industry Experiences Submitting Standardised Study Data to Regulatory Authorities

The 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 for ensuring 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, response to, and publishing of common SDTM and ADaM implementation challenges/nuances. This is important for sponsors who 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. Five primary categorical areas will be used for the FAQ.

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

 

 

 

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