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eSRA Maintenance

Self-Evaluating the GCP Compliance of Systems Holding Source Data

  • 1 March 2018
  • Author: Webmaster1
  • Number of views: 3135
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eSRA Maintenance

eSRA Maintenance Working Group

eSRA (eSource-Readiness Assessment) is a questionnaire used by sites to self-evaluate their electronic systems that may originate or manage data for clinical research.  It has been provided, free of charge, since 2016 and is updated annually, based on updates to the underlying regulatory documents and new interpretations from regulatory authorities.  It was developed and continues to be updated, with extensive participation of global biopharma, CROs, technology providers, academia and with regulatory review.

It is important that site systems that will supply source data for clinical research be designed and maintained to meet regulatory requirements. Sponsors ultimately bear the responsibility for ensuring that data harvested from these systems are acceptable, and investigators are frequently being asked to complete sponsor-specific assessments of their electronic record systems.  The eSRA project has developed a free tool that vendors and sites can use to quickly and easily evaluate their systems once for all sponsors, CROs, and regulators.

The tool offers a series of questions based on FDA, EMA and PMDA regulations and guidances. A site can quickly identify if its system and/or processes are compliant with research regulations or if additional processes need to be put into place. Using this assessment tool will enable sites to quickly provide the information needed by sponsors on GCP compliance of systems holding source data and will enable sponsors to evaluate and manage risk.

The eSRA Maintenance Working Group welcomes all feedback/questions on any of the eSRA materials offered via their web page (www.eclinicalforum.org/esra).  Please send feedback to esra@eclinicalforum.org.  All feedback/questions will be responded to. 

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eCF Views & News

eCF Views & News

We send out a brief monthly newsletter via email to all our active eCF members to keep them abreast of the activities of eCF that they can participate in. The more who participate, the better we are "A Network Powered by Peers". Click to see the most current newsletter.

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eCF Birds-of-a-Feather Webinar:  Site experience in the day-and-age of hybrid e-trials

eCF Birds-of-a-Feather Webinar:  Site experience in the day-and-age of hybrid e-trials

Back by popular demand!  Dr. van de Walle presented at the hybrid European eCF workshop in May … and we just ran out of time to answer all the questions! So many requests to ask Viviënne to present again with more time. So, here it is! Not to be missed!  Viviënne is a full-time investigator and founder of an indepenent research site. She has vast site and patient experience and will share her insight into how hybrid trials are going for the sites and the patients.

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