Guidance for Industry Electronic Source Documentation in Clinical Investigations

FDA’s HSP/BIMO Initiative

Do you have the processes in place to support these requirements?  Whether you are a sponsor or a site, this newly issued draft guidance applies to you.  This newly released guidance permits the direct documentation of data into the eCRF.  However, both the site and the sponsor must have the processes in place to ensure continued data integrity.  Sites must maintain a list of data originators, the site must have processes in place around password security and systems access, the Investigator must conduct ongoing review of data as it is recorded to ensure the safety of the subjects, real-time transmission of data must be managed in such a way as to ensure only reviewed data is released to the sponsor.  These processes are critical to ensuring compliance with this new draft guidance.  Keep in mind that even a draft guidance represents the agencies current thinking on a process.  DWD & Assoc can help you ensure that you have the processes in place to meet this newest guidance.

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