What is the basis for this Investigator Site eSource-Readiness Assessment Tool (eSRA)?

eSRA provides a practical context for the regulatory requirements and guidance documents (US and EU) governing clinical research records, systems & processes. The same responsibilities of the investigator to ensure that the source data are accurate, attributable, legible, contemporaneous, and original, exist whether those data are hand-written on paper or entered and stored electronically. Additionally, when an Electronic Health Record (EHR) system is the sole source of data for regulated clinical research, then the system must be compliant with these clinical research regulations. For example, data in EHR systems that are used for clinical trials, under various current regulations, require authority checks such as ensuring that only authorized persons can access the system, and maintaining a clinical research-compliant audit trail. Many of these requirements are also required of healthcare systems and/or otherwise considered good system practices. Regulatory documents relevant to clinical research data handling include the following. For a discussion on each regulation/guidance and its relevance to healthcare systems, please see Tab for "Regulations and Guidances applicable to Clinical Research Electronic Source Data".
  • Regulations and Directives

    • EMA Reflection paper on expectations for electronic source data and data transcribed to electronic data collection tools in clinical research (1-Aug-2010)
    • EU Annex 11 (30-June-2011)
    • EU Directive 2001/20
    • EU Directive 2005/28 EU Directive 95/46/EC (Data Protection)
    • EU Directive 75/318/EEC (July 1990)
    • FDA 21 CFR Part 11, Electronic Records; Electronic Signatures Final Rule (for reference only)
    • FDA 21 CFR Part 312, Investigational New Drug Application
    • US DHHS 45 CFR 170 Health Information Technology Systems; Electronic Health Records
    • US DHHS Health Insurance Portability and Accountability Act (patient & data privacy 45 CFR 160, 162, 164 ) (HIPAA)

  • Guidance Documents :

    • FDA Guidance: Computerized Systems Used in Clinical Investigations (CSUCI (May 2007)
    • FDA Guidance for industry Part 11, Electronic Records; Electronic Signatures- Scope and Application (August 2003)
    • FDA Guidance for industry: Electronic Source Data in Clinical Investigations (September 2013)
    • ICH E 6 Good Clinical Practice: consolidated guideline (1996) (GCP)
 

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