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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.

BARQA Seminar – Keeping up Standards 10/05/2012

Posted by Shirley Hallam in GCP audit, Quality Management.
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So you have set up your Quality Management System – what next?

This seminar organised by the BARQA Outreach Working Party will focus on audit strategy and quality evaluation in the non-commercial research sector.  The presenters will discuss essential elements of audit programmes, and share experiences from the front line of clinical and laboratory research.

What is an audit strategy? 
Intelligent sampling – How to get the maximum value out of your limited audit resource?
Selection of projects, audit activities.
Communication and dissemination of findings – sharing knowledge and best practice
Where does the audit end? – Follow up, corrective and preventative actions.

This will be of interest to anyone involved in managing non-commercial research, and especially those with the word “quality” in their title or job description!  Please come along, to learn and share together.

The seminar will take place on 5th July at Maple House, Birmingham.  Click here for more information.

The RQA Quality Systems Workbook 13/11/2011

Posted by Shirley Hallam in Quality Management.
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Help is at hand for anyone embarking on developing a quality management system in research and development.

Over the last few months, the Research Quality Associate (RQA) Outreach Working Party has been developing this accessible and practical workbook. Download a copy here.

“A Quality System sets out the standards that you are working to, and how you are going to meet them. The system should define what people, actions and documents are going to be employed in order to carry out the work in a consistent manner, leaving evidence of what has happened. It may include manuals, handbooks, procedures, policies, records and templates. The terminology used is less important than the purpose and use of the documents. The fundamentals of a Quality System are the same regardless of what your work is. The same principles can be applied whether you are an academic research laboratory, a medical device manufacturer or a hospital clinical trials unit

“Understanding, interpreting and implementing a Quality System is a skill in its own right.

“The aim of this new Workbook is to provide tools and a practical approach to develop a Quality System that works for the user.

“The Workbook concentrates on the core, underlying principles of quality which are pivotal – explicitly or implicitly – to all quality management standards that impact on research and development.

“These principles are also fundamental to the conduct of efficient, reliable and credible scientific and clinical work and will help the user to design and implement a practical Quality System that works for their organisation to make it more productive and compliant.

“The workbook may also help users in the task of persuading others of the importance of such a system. It is aimed at the doers within the Outreach target audience who will either have been delegated the task or are volunteers who have seen the need for a Quality System.”  RQA OWP

The Work book is available to both RQA Members and non-members as a free download here.