Data Standards and role of Clinical Trial Team

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.