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

Posted by Shirley Hallam in Quality Management.
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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.

Declaration of Helsinki 2013 21/10/2013

Posted by Shirley Hallam in Ethics.
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WMAThe World Medical Assembly has published a new version of the Declaration of Helsinki. The 2013 version, formally ratified at the WMA meeting in Fortaleza, Brazil, includes:

  • requirement for risk assessment – physician must have confidence that risks can be adequately managed
  • where a relationship of dependence exists between the physician and a potential trial participant, informed consent must be sought by an appropriately qualified individual who is completely independent of this relationship
  • clarification on the use of placebo: only when no proven intervention exists or the use of placebo is necessary to determine the efficacy or safety of an intervention, and  patients will not be subject to additional risks of serious or irreversible harm as a result of not receiving the best proven intervention
  • clarification on post-trial provisions:  In advance of a clinical trial, sponsors, researchers and host country governments should make provisions for post-trial access for all participants who still need an intervention identified as beneficial in the trial
  • clarification on registration and publication:  trials must be registered in a publicly accessible database before recruitment of the first subject; and researchers, authors, sponsors, editors and publishers all have ethical obligations with regard to the publication and dissemination of the results of research
  • provisions for the use of unproven interventions to offer hope of saving life, re-establishing health or alleviating suffering.

The full text is available from the World Medical Assembly website.