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Questions about e-source? Maybe this will help...

lkeitalkeita Posts: 50
edited April 2014 in Regulatory Compliance
I've received questions recently about electronic source records in clinical trials. This is pretty recent guidance from the FDA, and the folks asking about e-source weren't familiar with this document, so I thought I'd spread the word. I hope it helps answer any questions you may have about e-source.
Post edited by bbaumann on


  • tdpurnattdpurnat Posts: 126
    edited March 2014
    SCDM eSource task force recently circulated their white paper draft for comments, and I assume they will be publishing the white paper “eSource Implementation in Clinical Research: A Data Management Perspective” soon.
    The document is very useful and I recommend reading it.

    I think the recent push to formalize the validation of IT systems used in clinical research and putting more accountability on the owners of the system for the business processes aroudn it adn its maintenance are very good.

    Although I think the eSource discussion spans way beyond the use of Open Clinica. One may interface it with other systems that can draw upon eSource, and some data captured in OC might even go towards this field (like patient outcomes, evaluations). But I would argue Open Clinica as a standalone system right now is more of an EDC solution. With OC, one must focus on good CRF design, workflows, and keep pushing OpenClinica LLC for good system design.

    What do you think?
  • vidyadharpujarividyadharpujari Posts: 11
    Hi Tdpurnat,

    I completely agree with you, we must focus on good, effective and user-friendly OC for future.


    Dr. Vidyadhar S Pujari
This discussion has been closed.