LEVERAGING KNOWLEDGE - DRIVING PERFORMANCE - DESIGNING THE FUTURE

Clinical Forum Teams work extensively with industry, healthcare organisations, academia regulators to link stakeholders and to facilitate the development of the environment for electronic clinical research. We have conducted surveys, developed tools, built an extensive base of knowledge of information relevant to the successful implementation of eClinical solutions.

Join the eClinical Forum to participate in cross-industry initiatives and to benefit from early access to pre-competitive information on best practices and trends.

ECF Teams and Projects

Suzanne Bishop (Americas Administrator)
/ Categories: Regulatory, Visible by Public, Ended, PUBLIC DOWNLOADS, Report

Investigator’s signature on electronic Case Report Forms (eCRFs)

Best Practices

There is increased scrutiny by regulatory agencies on the collection of investigator’s signature as evidence of the overall oversight on the eCRF data reported to the sponsor.
Due to different interpretation on the timing and frequency for the collection of the investigator’ssignature, an eCF Task Force has been formed to identify best practices that are based on the compliance to regulatory requirements and on risks such as reputation, credibility, legal liability of the data being used by the sponsor. The intent of this document is to provide a framework for individuals’ risk‐based decisions and best practices for implementing solutions for investigators’ signature collection on data reported to sponsor.

Print
29 Rate this article:
No rating