| Regulatory |
CRF Inc.'s ("CRF") technology collects electronic patient data and electronic patient diary data that qualify as ICH-GCP Source Data & Documents. Therefore, CRF is required to comply with US and EU regulatory rules and guidelines. CRF's systems meet these requirements, including but not limited to 21 CFR § 11, 21 CFR § 312, 21 CFR § 314, 45 CFR § 160/164 HIPAA, Directive 95/46/EC, Directive 2001/20/EC, and FDA CSUCT guidance.
CRF's quality systems follow the tenets of ISO 9001:2000 Quality System, ISO 12207:1996 Software Lifecycle, and ISO 17799:2000 Information Security. CRF's adherence to these, globally sanctioned, consensus standards aids in CRF's ongoing endeavors to ensure that all CRF products and services meet regulatory expectations and scrutiny.
CRF utilizes key ICH-GCP principles in order to manage data accuracy, (§2.10). The purpose of identifying data as "source", is to always be able to authenticate any copy via source document (data) verification ("SDV") activities.
CRF considers all of its end-user devices as transient ("Transient Devices"). These Transient Devices either display data that is pushed from CRF's servers or acquire data from users and temporarily stores such data inside such Transient Devices. However, as part of a normal workflow these Transient Devices pass data onto CRF's centralized databases before the process tasks are completed.
Additionally, CRF defines it's clinical data collection devices as transient data collectors ("Transient Data Collectors"). CRF does not consider, or provide for, permanent "source data" storage in these Transient Data Collectors since by the nature of such Transient Data Collectors the permanent "source data" storage classification is impractical to archive. However, it should be noted that, some of the Transient Data Collectors do have removable memory cards – these memory cards are used only for disaster recovery purposes. The data these Transient Data Collectors collect is migrated to CRF's database, (wired and wirelessly), in a secure and validated manner.
Data collected via the Transient Devices and Transient Data Collectors resides in CRF's databases (with controlled access) until final data transformation and data migration to the applicable sponsor's databases and investigator copies are needed. This is facilitated 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 US FDA's Good Clinical Practices GCP's section 2 by incorporating new technology, in a realistic manner, using sound engineering judgment.
CRF's personnel are an active part of the DIA, EDMF, and PDA group, which allows CRF to (i) take an active role in discussing these topics; (ii) providing input into such processes for consideration by applicable regulators; and (iii) stay ahead on seminal trends in the industry.
European Union Data Protection Act
In accordance with Commission Decision 2002/16/EC of 27 December 2001 on standard contractual clauses for the transfer of personal data to third countries, under Directive 95/46/EC, the Annex titled "Standard Contractual Clauses" is hereby incorporated by reference in its entirety. With respect to such Annex the "data exporter" shall be defined as "You" and the "data importer" shall be defined as "CRF". You may find a complete version of the text by clicking on this link – { Commission Decision 2002/16/EC }
Government End-User Notice
CRF’s Software is a "Commercial Item," as that term is defined at 48 C.F.R. § 12.101, consisting of "Commercial Computer Software" and "Commercial Computer Software Documentation," as such terms are used in 48 C.F.R. § 12.212 and 48 C.F.R. § 227.7202, as applicable. Consistent with 48 C.F.R. §§ 12.212, 227.7202-1 through 227,7202-4, the Commercial Computer Software and Commercial Computer Software Documentation are being licensed to U.S. Government end-users (a) only as Commercial Items and (b) with only those rights as are granted to all other end-users pursuant to the terms and conditions herein.
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