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.-PM., P.M.P.
Click here for complete trainer
biographies
$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.
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#: 0778-0000-20-052-L01-P.
Released: 1/20.
Hold
this course at your company! For more information, contact Naila Ganatra at +1
215.413.2471.