groups » Data Management and Statistics » Database systems for Phase IV trials

Hi,
We have been involved in a number of clinical trials over the last couple of years as a data management centre with Openclinica (www.openclinica.org) being our preferred software of use. The trials have been primarily phase II & III trials and we are now moving towards phase IV (pharmacovigilence) trials.
Are there other open source systems we can use for the phase IV studies as i think Openclinica seems too complex/detailed for these type of studies which are straight forward where we only collect at most 2 pages of patient information.

Raymond.

Reply

  • Naomi Naomi Waithira 24 May 2012

    Hi Ray,

    This might not be a direct response to your question as the system is not completely FDA CRF part11 compliant, but is something that we are starting to use in our institution for collection of surveillance data.REDCap is a web-based data collection tool(http://project-redcap.org/). Setup of the system is much easier compared to OpenClinica. I have attached a review done by one OpenClinica user comparing REDCap and OpenClinica.

    Attached files: Naomi_Waithira_doc_for_discussion_board.pdf

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