As the use of electronic source documentation (eSource) increases, so does the scrutiny for ensuring the integrity of the systems used to generate and retain electronic source data. In late 2010, the FDA issued a draft guidance regarding the use of electronic source documentation, providing direction to sponsors, CROs, data management centers, and Clinical Investigators on capturing, using, and archiving electronic data in FDAregulated clinical investigations. After a comment period, a new draft guidance was released in late 2012 focusing on identification and specification of authorized source data originators, the creation of data element identifiers to facilitate examination of the data audit trail, capture of source data into the eCRF, and Investigator responsibilities with respect to reviewing and retaining electronic data. This web seminar will review how the requirements for paper source documentation translate to the electronic source document as well as examine real-world examples of the FDA’s review of eSource.
- Navigate initiatives in the current regulatory climate leading to the eSource guidance
- Examine the three tiers of data management: Data entry, data review, and data processing and transmission
- Discuss the Clinical Investigator’s responsibilities for eSource data origination, integrity, review, release for processing and retention
- Assess the implications of the guidance on current source documentation practices and policy
- Review the FDA’s expectations and inspection processes for eSource
- Clinical Research Associates
- Project Managers
- Clinical Research Associate Managers
- Clinical Investigators and Staff
- Clinical Research Professionals involved in site and IRB assessment and/or selection
- Professionals from Academia involved in the oversight, documentation, and conduct of clinical research
- Quality Assurance and Compliance Professionals
- Data Management Professionals
Elizabeth Ronk Nelson, M.P.H.
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Includes up to 20 participants at one site. All participants (up to 20) are eligible for “Certificates of Attendance,” and accreditation, provided that accreditation requirements are met. For groups larger than 20 or for additional sites, please call 1-800-856-2556 for pricing.
Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 2 hours (0.2 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation. Barnett International will mail ACPE statements within three weeks of program completion. ACPE#: 0778-0000-11-061-L01-P. Released: 9/11.
Hold this course at your company! For more information, contact Naila Ganatra at (215) 413-2471.