jump to navigation

FDA publishes guidance on Electronic Data Capture in eCRFs 24/10/2013

Posted by Shirley Hallam in Quality Management.
trackback

EDCThe United States Food and Drugs Administration (FDA) has published new guidance on the use of electronic data capture in clinical trials.
The guidance addresses source data in clinical investigations used to fill the predefined fields in an electronic case report form (eCRF), according to the protocol and includes the following areas:

• Identification and specification of authorized source data originators
• Creation of data element identifiers to facilitate examination of the audit trail by sponsors, FDA, and other authorized parties
• Ways to capture source data into the eCRF using either manual or electronic methods
• Clinical investigator(s) responsibilities with respect to reviewing and retaining electronic data
• Use and description of computerized systems in clinical investigations
This guidance is intended to be used together with the FDA guidance for industry on Computerized Systems Used in Clinical Investigations, and on Electronic Records and Electronic Signatures.
The full text of the guidance can be found on the FDA website.

Comments»

No comments yet — be the first.

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out /  Change )

Google photo

You are commenting using your Google account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s

%d bloggers like this: