FDA Requirements for Electronic Source Data in Clinical Investigations
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 In late 2010, the FDA issued a draft guidance regarding the use of eSource, providing direction on capturing, using, and archiving electronic data. A final FDA guidance was released in September 2013 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. 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 regulatory climate leading to the eSource guidance
- Examine the three tiers of data management
- Discuss the Clinical Investigator’s responsibilities for eSource data origination, integrity, review, release for processing and retention
- Assess the implications of the guidance on source documentation practices and policy
- Review the FDA’s expectations and inspection processes for eSource
Who Should Attend
- Clinical Research Associates and Managers
- Project Managers
- Clinical Investigators and Staff
- Personnel involved in site and IRB assessment and/or selection
- Academia Professionals involved in oversight, documentation, and conduct of clinical research
- Quality Assurance and Compliance Professionals
- Data Management Professionals
Elizabeth Ronk Nelson, M.P.H.
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 +1 781.972.5400 or toll-free in the U.S. 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 issue a receipt of completion for earned CEUs within three weeks of program completion. ACPE#: 0778-0000-20-032-L01-P. Released: 1/20.
Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.