Lack of adequate and/or accurate source documentation has been noted as a common deficiency in inspection findings of Clinical Investigators, and regulators report that quality source documents reinforce quality site data. Regulatory requirements (FDA, ICH) will be reviewed in this web seminar. Further, the following topics will be covered: Variability of stakeholder requirements (sponsor-to-sponsor, per study, sponsor to site), case report forms (CRFs) as source data, electronic medical records, shadow charts, source document worksheets, protocol deviations, telephone and email contacts, good documentation practices, making corrections to source documents, late entries, back-dating (oh no!), and details of FDA inspection methods and findings regarding source documents. Leading practices will be discussed to assist sites with implementing the regulatory requirements for source documents.
- Define source data and source documents
- Identify regulatory required characteristics of source data and source documents
- Identify three attributes of source document worksheets
- Describe three attributes of ALCOAC (attributable, legible, contemporaneous, original, accurate, complete) for source documents
- Discuss CRFs as source data
- Site Research Directors/Managers
- Clinical Research Coordinators
- Principal Investigators
- Clinical Research Associates
- Project Managers
- Clinical Research Associate Managers
- Quality Assurance Personnel
Marla Hoelle, R.N., B.S.N., C.C.R.A., P.M.P.
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Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.