What goes in a Submission to a Health Authority?
Quite a bit! We will focus on the data deliverables and supporting
documentation needed for a successful submission to a Health Authority
and how {xportr} can play a key role. We will briefly look
at three parts:
- Study Data Standardization Plan
- SDTM Data Package
- ADaM Data Package
Study Data Standardization Plan
The Study Data Standardization Plan (SDSP) establishes and documents
a plan for describing the data standardization approach for clinical and
nonclinical studies within a development program. The SDSP also assists
the FDA in identifying potential data standardization issues early in
the development program. We hope the brevity of this section does not
belie the huge importance of this document. Please see Study
Data Standardisation Plan (SDSP) Package maintained by the PHUSE
working group. However, we want to focus more on the actual data and
how {xportr} can play a role in the submission.
SDTM and ADaM Data Packages
SDTM: The primary pieces of the SDTM package are the SDTM annotated case report forms (acrf.pdf), the data definitions document (define.xml), the Study Data Reviewer’s Guide (sdrg.pdf) and the datasets in xpt Version 5 format. The Version 5 xpt file is the required submission format for all datasets going to the Health Authorities.
ADaM: The key components of the ADaM package are very similar to SDTM package with a few additions: define.xml, Analysis Study Data Reviewer’s Guide (adrg.pdf), Analysis Results Metadata (analysis-results-metadata.pdf) and datasets as Version 5 xpt format.
As both Data Packages need compliant xpt files, we feel
that {xportr} can play a pivotal role here. The core
functions in {xportr} can be used to apply information from
the metadata object to the datasets giving users feedback on
the quality of the metadata and data. xportr_write() can
then be used to write out the final dataset as an xpt file,
which can be submitted to a Health Authority.
What is {xportr} validating in these Data
Packages?
The xpt Version 5 files form the backbone of any
successful Submission and are govern by quite a lot of rules and
suggested guidelines. As you are preparing your data packages for
submission the suite of core {xportr} functions, plus
xportr_write(), helps to check that your datasets are
submission compliant. The package checks many of the latest rules laid
out in the Study
Data Technical Conformance Guide, but please note that it is not yet
an exhaustive list of checks. We envision that users are also submitting
their xpts and metadata to additional validation
software.
Each of the core {xportr} functions for applying labels,
types, formats, order and lengths provides feedback to users on
submission compliance. However, a final check is implemented when
xportr_write() is called to create the xpt.
xportr_write() calls xpt_validate(),
which is a behind the scenes/non-exported function that does a final
check for compliance. At the time of {xportr} v0.3.0 we are
checking the following when a user writes out an xpt
file.:
