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What’s New in GCP August 8, 2017

Posted by Michael Hamrell in Uncategorized.

I haven’t updated this Blog in some time, but i thought it would be a good idea to write about what is new, and not so new in GCP.

In September 2013, FDA published a Guidance on Electronic Source Data in Clinical Investigations.  This guidance provides recommendations to sponsors, Contract Research Organizations (CROs), clinical investigators, and others involved in the capture, review, and retention of electronic source data in FDA-regulated clinical investigations.  The guidance promotes capturing source data in electronic form.  It is intended to assist in ensuring the reliability, quality, integrity, and traceability of the data from electronic source to electronic regulatory submission.

In December 2016, the FDA also published a Question and Answer Guidance on the use of electronic informed consent.  This guidance has been prepared jointly by the Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA). This guidance provides recommendations on the use of electronic systems and processes that may employ multiple electronic media to obtain informed consent for both HHS-regulated human subject research and FDA-regulated clinical investigations of medical products, including human drug and biological products, medical devices, and combinations thereof.


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