Fundamentals of the new FDA inspectional record requirements for EDC and EDE clinical trials

Duration: 60 Minutes
This webinar deals with basics of new FDA inspectional record requirements for EDC/EDE clinical trials. Case history of multiple site trial that uses EDC to be presented. For electronic record function procedures, changes might be possible to remain in compliance with the compliance inspectional standards.
Electronic Data Capture
Product ID: 500484
  • We will compare the text of the guidance to current FDA regulations.
  • Discuss the FDA current inspectional practice.
  • Explore investigator documentation practices that are FDA acceptable.
  • Additional options as offered by webinar participants.
Pharma and Investigators seek to minimize the burden of documentation in the conduct of clinical trials. The use of Electronic Data Capture for source documents coupled with Direct Data Entry still requires significant investigator site record documentation to comply with FDA compliance inspection requirements. Study data that does not comply with the inspectional standards will not likely be accepted by the FDA. FDA enforcement actions are possible against both the investigators and sponsors. We now have a new and much debated final GUIDANCE.

There are still questions. The guidance addresses Electronic Data Submission, Electronic Records, and the standards for computerized data capture and reporting systems. This guidance does not fully address the investigator site procedures that may be required for compliance. This webinar will address the investigator site electronic records function as it presents an interface between all three of the guidance functions.

Why Should you Attend:
Investigators commonly assume that the new guidance and regulations reduce the need for source documentation in clinical trials. In fact, there are new procedural documents relevant to the electronic source documents and direct data entry that are required to comply with the current inspectional standards and the final guidance. The inspectional compliance objectives have not changed. The GCP compliant conduct of the clinical trial must be documented for all clinical trial functions. The case study will illustrate what happens without this procedural documentation.

Objectives of the Presentation:
  • Does the new guidance reduce or change the burden of documentation for investigators and sponsors where electronic records/ case histories/ source documents are utilized?
  • Exactly what study data do not now require source documentation?
  • What original source documentation is still required for an inspection?
Who can Benefit:
  • Clinical Research Coordinators and investigators
  • Medical Record personnel
  • Clinical CRA Monitors
  • Clinical Program Managers
  • Clinical Quality Assurance Auditors
Live Session - How it works
  • Username and Password will be sent to you 24 hours prior to the webinar
  • Presentation handouts in pdf formate will be mailed to you
  • Login to the session using the username and password provided to you
  • Get answer to your queries through interactive Q&A sessions via chat
  • Please let us know your thoughts and views at the end of webinar, your valuable feedback will help us improve
  • Get certification of attendance.
Recorded Session - How it works
  • A link will be provided to you upon purchase of the recorded session
  • Please click on the link to access the session
  • Presentation handouts in pdf formate will be mailed to you
  • Get certification of attendance.
$300
Recorded Session for one participant
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How it works
Live Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • The webinar joining link, username and password for joining the webinar will be updated on your OCP Account 24 hours prior to the webinar
  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Founder of Commonwealth Clinical Research Services (later as Solaris Research Corporation), a full service CRO from 1989 to 2009. He has a degree in microbiology/infectious disease. Steve worked in clinical project development for Pharma for 16 years and for 20 years as a CRO with experience in devices, biologicals, diagnostics, and therapeutics in most of the areas of clinical research for all study phases, as well as pre-clinical activities.

Steve has extensive field experience as a CRA and as a CQA auditor, He has expertise in Clinical Operations, including the functions of clinical monitoring, program management, product development, CQA, and inspectional operations. He has recently retired from Pharma where he was Sr Manager, Global Clinical Operations. His current activities as a consultant include CQA inspections and training, Gap Analysis Audits, and Clinical Project Oversight.

Steve has served on an IRB and has served as PI on several phase four studies. He has published a monthly international clinical trial conduct newsletter (2000-2008) and has been a frequent presenter of webinars, and seminars over a broad range of topics for FDA News and Thompson Publishing and Bioforum. GCP, Regulatory, and CQA training of academia, government (US and Canada), and pharma staff have been a large part of his activities since 1994.

His many years of experience and expertise and his interactive presentations enable participant interaction and exchange of information/options.
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