Lack of adequate and/or accurate source documentation has been noted as a common deficiency in inspection findings of Clinical Investigators. There is significant variability between stakeholder requirements regarding source documentation per study, including sponsor to sponsor, sponsor to site, etc. The creation and use of source document worksheets and the use of the Case Report Form (CRF) as the original source have raised a lot of industry debate. These issues and more regarding adequate and accurate source documentation to meet the requirements of regulatory agencies essential documentation standards will be presented and discussed.
- Define source documents
- Identify regulatory authorities required characteristics of source data
- Analyze source document worksheets: The love-hate relationship
- Discuss the CRF as source data
- Evaluate best practices
- Site Research Directors/Managers
- Clinical Research Coordinators
- Principal Investigators
- Clinical Research Associates
- Project Managers
- Clinical Research Associate Managers
- Quality Assurance Personnel
Nikki Christison, B.S., C.C.R.A.
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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#: 0778-0000-14-033-L01-P. Released: 3/14.
Hold this course at your company! For more information, contact Naila Ganatra at (215) 413-2471.