Anything else to consider?
Maintaining inventories & using computerised systems for inventories
Maintaining inventories of all essential records.
To further the case for a consolidated repository is the inclusion of advice on the maintenance of ‘inventories’ within the new guidelines.
“The sponsor and investigator/institution should maintain a record of where essential records are located, including source records. The storage system(s) used during the trial and for archiving (irrespective of the type of media used) should provide for appropriate identification, version history, search and retrieval of trial records.”
As the number of live systems adopted throughout a clinical trial increases (and any resulting data migrations), it becomes more difficult to create and maintain inventories. I would argue that this further strengthens the case for a consolidated long-term archive for any trial that has closed.
As the number of live systems... increases...it becomes more difficult to create and maintain inventories.
"...must be a clear understanding of how that system supports the retention of data for the entire lifecycle.'
The use of computerised systems for retention.
Given the shift from paper to digital, (in part driven by the use of more digital technologies) it follows that we need to look at digital solutions for record retention.
Arkivum has published several documents to support the process for selecting the right supplier so I won’t cover this here. If you are interested in finding out more, we have recently hosted a webinar on the topic and also published an eBook guide.
What I do want to highlight from the guide is that R3 now has a dedicated section for computerised systems (section 4.3), which details their use within a clinical trial. This includes (but definitely not limited to!);
- That they are fit for purpose, particularly within the context of a clinical trial.
- The systems that have been selected for use have been done so in a risk-proportionate manner.
- The party responsible for developing the system (i.e. the vendor) is aware of the intended use and aware of the regulatory requirements that apply to them (and their system).
- Procedures for the use of the system, including data collection, handling and management should all be documented.
- All systems used throughout the entire lifecycle of the trial must be validated.
We could perhaps summarise these points by saying that supplier assessment and qualification are implicit in the use of validated systems and are part of determining that the system is fit for purpose by checking it is designed, developed, delivered and supported by an organisation with appropriate staff, policies and procedures (QMS), training and understanding of the regulations.
In the context of using an appropriate system for the retention and archival of study data, I think it’s important to spell out that there 1) must be a clear understanding of how that system supports the retention of data for the entire lifecycle and 2) that that system must also be validated.
If we think back to the traditional approaches to retaining study data, I would argue that most of those listed, do not meet the criteria for both of these.
The systems that have been selected for use have been done so in a risk-proportionate manner.
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