I have to agree that the journey of submission was not easy using
new data standards - found few obstacles in the way, fixed obstacles without
sacrificing the SOPs and guidelines but we learned priceless learnings. And
today I am going to discuss one of the learning.
When it comes to data submission to health authorities, most
of the internal and external stakeholders consider that this is the
responsibility of statistical programmers. As a programmer I will not deny this
part because certainly we are the primarily responsible team to develop CRTs as
per the HA guidelines.
BIG Questions:
1. Are
we only involved in data standards?
2. Is
it single line function responsibility to develop FDA approved CDISC format data
for submission?
Without any hesitation, I say NO – its entire Clinical Trial
Team responsibility to maintain data in standard format from eCRF to eCDT.
Let’s have a roles and responsibility of each line function
and where they can contribute to meet new data standards format for clinical
drug submission process.
Clinical Team:
Clinical team needs to have clear direction of the data
collection as per new the clinical data standards while reviewing the case
report forms and third party data transfer specifications. Visit schedule
assessments and TV domain design plays vital role while setting up the database
for the study.
Data Management:
Should have clear understandings about CDASH and SDTM
standards – I know it’s difficult to collect SDTM data in database (most
challenges will come from investigators and data cleaning process) – but data
must be close to the SDTM standards then Statistical reporting can do the data
transformation and can make ease transformation data from SDTM like to Pure
SDTM domains.
Statisticians:
Statisticians must provide clean and effective Trail design
Domains, TDM domains plays a vital role in the development of Pure SDTM.
Programmers:
Programmer is responsibility person to develop data domains
which satisfy the CDISC /FDA standards – and should support CSR and pool analysis
and should satisfy the Open CDISC and Janus checks. We will discuss point by
point about Statistical programmers role in CDISC data standards submission to
Health authorities.
