What does good practice for managing data from wearables look like?
Clinical Data is Regulated
This means that depending on location, that data will have to abide by many rules stipulating how it should be retained, audit trails of actions taken against the files, how long it is to be retained for and more.
Geographic regions the trial is being carried out in and where it will be marketed once (if) approved will both determine the jurisdiction it falls within:
- The EMA for the EU
- The FDA for the US
- The MHRA for the UK
...and they will have various rules and standards.
Data Retention
We have recently witnessed the EU releasing updated and more intense regulations regarding the retention period of the eTMF in which it is now a requirement to retain it for a minimum of 25 years (whilst FDA guidance doesn’t provide a specific timeframe)
EU Regulation 536/2014.
Data Retrieval
“Protection of records to enable their accurate and ready retrieval throughout the records retention period...”
FDA 21 CFR 11.10.
Audit Trails
An audit trail facilitates the reconstruction of the history of such events ...including the “who, what, when and why” of the action. [TMF] system design should always provide for the retention of audit trails.
MHRA GXP Data Integrity Guidance and Definitions Sec 6.13.
With the above and pre-existing additional data retention requirements in mind, we can be safe in assuming that the integrity of data collected will continue to be a key driver for rules and regulations and will sequentially be analysed critically.