The Roles Of CRO In Data Standards Governance

The Roles Of CRO In Data Standards Governance

In this article we shall discuss the roles of CRO in data standard governance. As CDISC compliant submissions has become mandatory, biopharma companies are thinking how to approach the issue of data standards governance.

Standards governance is essential in the management of CDISC compliance and is also important for promoting standards awareness within the organizations. It’s also a trending and hot topic in the industry and happened to form a substantial track at 2016’s CDISC EU Interchange early in April.

Nowadays it has become a tradition rather a common practice for biopharma companies to outsource their CDISC conversion of legacy data for the sole purpose of publications and submissions to good CROs.  While large biopharma organizations might have dedicated in-house teams deployed to the management of standards governance, the dynamic nature of CDISC requirements means companies could struggle to find the resources to keep up to date and give the best interpretation of documentation. Outsourcing could be a better option to make sure dedicated staffs are available to manage and supervise these aspects and make sure that companies stay submission ready.

A dedicated standards governance committee will be basically multidisciplinary across the sponsor’s clinical research team and might also take input from the CRO. 

The committee will look after an organization’s approach to:

  • Standard CRF pages/ CDASH
  • Structures of SDTM
  • Structures of ADaM

and decisions around the following aspects:

Application of data standards libraries (mainly while outsourcing to CROs).

One of the problems which is essential to address as part of standards governance is how the standards must be deployed by CROs, and making sure with the compliance with those standards.  An effective approach is for a CRO to be contracted to be responsible for standards governance, and effectively look over the adherence to those standards by the CROs responsible for the creation of datasets and outputs for specific studies. This can offer a solution for a biopharma business without much resources for a team in an in-house governance, while still managing the integrity and compliance to their standards.

How deviations from the current data standards will be dealt, and how to track which version of the data standards is used for each study.

Where any deviation is seen from the standards, this will be referred back to the governance committee and a decision would be made on how to address the deviation.  This can also be considered as a learning point moving forward.  

How and when the data standards will be updated, modified and changes controlled.

CDISC amendments related to data collection via analysis, and across therapeutic areas are set out on a regular basis.  To monitor these amendments, assess their relevance to the organization, interpret and implement a resource intensive process. The governance committee must be responsible for reviewing and making a decision whether a specific amendment is something which they would want to consider.  The amendments could be open to interpretation, and hence having the right expertise involved, capable of understanding the amendments which are significant to a particular organization is essential. 

We conclude the discussion here. Stay connected with us this space for more discussions.

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