Site Transition to eSource and eISF (Electronic Investigator Site File)
$79.00 (Non-Member Price)
$0.00 (SCRS members – Included as member benefit, no additional cost)
Many clinical research sites are looking to improve efficiency and reduce the burden created by paper documentation. During the webinar, the speaker will identify reasons to make the leap to electronic source and regulatory documents and will discuss considerations for site as they begin implementing paperless solutions. Experiences with sponsor/CRO acceptance and aids for resolution of concerns will also be presented.
- Learn about regulations and FDA guidance surrounding electronic documentation at sites.
- Understand requirements and features to evaluate and choose the right electronic record systems for your site.
- Learn about potential pitfalls and how to avoid and/or resolve issues with acceptance of electronic records.
- Understand why clinical research sites should drive the transition to electronic records.
William Dirkes, Jr. MD, MBA
Sentral Clinical Research Services and SentralBinders
Dr. Dirkes previously worked at a central IRB before starting his own clinical research center. Both with the IRB and the research site, it quickly became clear than the industry needed to move away from paper. SentralBinders is an electronic source and regulatory document management system, developed by a clinical research site, for site use. Sentral Clinical Research Services has been using electronic source and regulatory documents for more than two years and has implemented the system for all of their studies. The combination of electronic source and electronic regulatory allows the possibility of being paper free not just paper less.
Society for Clinical Research Sites, Inc. is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center’s Commission on Accreditation.
To obtain your Contact Hours for this webinar:
- The webinar must be watched in its entirety.
- The post webinar survey immediately following this webinar must be completed in its entirety.
- Your contact hour certificate will be sent to you within 30 days of you viewing this webinar.
- The contact hour certificate will be sent to the email address provided when you registered.
Planners, presenters, faculty, authors, and content reviewers do not have any relevant financial relationships with any commercial interest.
This webinar does not imply any endorsement of products or services by the Society for Clinical Research Sites or ANCC.
The materials and recording of this webinar will be available for one year as an archive, but will not award any contact hours.