Skip to main content

You are here

Data Management

Noclor do not provide in-house data management services; the responsibilities for data management and statistical analysis are delegated out to appropriately qualified individuals (in accordance with ICH-GCP (5.5)).  The individual delegated responsibility is usually the Chief Investigator (who may then onward delegate to other members of the study team).  For more complex clinical trials it is likely that data management and statistical expertise will be outsourced to a third party (either a collaborator/academic partner or utilising the data management services of  a Clinical Trial Unit (CTU)).

The data management requirements and processes for a specific study should be addressed early on in the study development/ funding application stages so that costs (and appropriate contracts) can be considered and any potential risks can be assessed. All research studies should have a data management plan documented (at a minimum the plans outlined in the protocol, and for more complex clinical trials a dedicated data management plan (document) will be required) prior to the study commencing which explicitly addresses data capture, management, QC checks, validation, confidentiality, retention, security and back-up, data-lock, sharing and publication.

Good data management in research is not just about planning; monitoring systems must also be place to identify data and compliance issues as they arise so that they can be addressed (by amendment to protocol or data capture tools/additional training or further documented instructions) and reported as appropriate to prevent escalation of issues into the worst case scenario (serious breach).