Source Documentation: What is Adequate & Accurate?

Course Description

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.

Learning Objectives

• 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

Who Should Attend

• Site Research Directors/Managers
• Clinical Research Coordinators
• Principal Investigators
• Clinical Research Associates
• Project Managers
• Clinical Research Associate Managers
• Quality Assurance Personnel

Instructor

Marla Hoelle, R.N., B.S.N., C.C.R.A.-PM., P.M.P.

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Registration Fees

$835

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.

Accreditation Information

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#: 0778-0000-17-053-L01-P. Released: 4/17. 

Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.