| Regulatory |
CRF Inc. technologies collect electronic patient data and electronic patient diary data that qualify as ICH-GCP Source Data & Documents. This requires our compliance to US and EU regulatory rules & guidelines. CRF systems meets these requirements, including 21CFR§11, 21CFR§312, 21CFR§314, 45CFR§160/164 HIPAA, Directive 95/46/EC, Directive 2001/20/EC, and FDA CSUCT guidance.
Our quality system follows the tenets of ISO 9001:2000 Quality System, ISO 12207:1996 Software Lifecycle, and ISO 17799:2000 Information Security. Our adherence to these, globally sanctioned, consensus standards ensures that our products meet regulatory expectations and can pass regulatory scrutiny.
The key ICH-GCP principle we manage is to ensure data accuracy,(§2.10). The purpose of identifying data as "source", is to always be able to authenticate any copies via source document (data) verification (SDV) activities.
We consider all of our end user devices, transient. They either display data that is pushed from our servers or acquire data from users, and temporarily store it inside these devices, but as part of normal workflow, pass the data onto our centralized databases before the process task is complete.
We define our clinical data collection devices as Transient Data Collectors. We do not consider, or provide for, permanent "source data" storage in these devices as they are impractical to archive. Some of the data collection devices do, however, have removable memory cards but that are used only for disaster recovery purposes. The data these devices collect is migrated to our database, (wired and wirelessly), in a secure & validated manner. We "practically" declare, that CRF Inc databases are the first permanent location for collected data and are defined as the "durable media" e-source data location.
This data resides in our databases, (with controlled access), until final data transformation and data migration to sponsor databases and investigator copies is needed. This is always done in a validated manner consistent with IEEE validation principles. It is important to note that Regulatory agencies have not taken definitive opinions or published guidance documents on electronic source in electronic patient diary trials. Our interpretation and principles are in keeping with GCP section 2 by incorporating new technology, in a realistic manner, using sound engineering judgment.
CRF Inc personnel are an active part of the DIA, EDMF, and PDA groups discussing these topics and are providing input into the process for input to regulators. We strive to keep abreast of current policy with regard to ePRO. Please contact us to discuss this in more detail. |
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