Adequate and accurate source documentation in clinical research is critical to ensuring subject safety, data integrity, and investigators meeting regulatory expectations. Appropriate monitoring of source data is also vital for the sponsor stakeholder performance. Best practices will be presented and applied as participants work through a simulated clinical research study from first subject, first visit, to site-close out - while examining source documentation from the perspective of the CRC, CRA, and the auditor. All of the regulatory required attributes of quality source data will be presented and applied using real-life case studies, simulations, and interactive group exercises. Participants, sponsors/CROs and/or research sites will gain new insights into the role source documentation plays in the clinical research process.
Employ the regulatory required attributes of quality supporting source data to case scenarios
Describe what is required for electronic data from electronic health records and/or e-CRFs to be 21 CFR Part 11 compliant
Argue for and against the use of source document worksheets
Identify the process for documenting deviations from the protocol and Good Clinical Practice (e.g., notes-to-file, and creating and documenting corrective and preventative action plans)
Determine how best practice source documentation can be incorporated into any clinical research environment
Clinical Research Associates
Clinical Research Coordinators
Site Managers
CRA Managers
Clinical Research Trainers
Principles Investigators
Clinical Research Professional looking to move into a quality assurance role
The course will be led by one of the following instructors:
Karen Gilbert, B.S., C.C.R.A.
Sandra “SAM” Sather, M.S., B.S.N., C.C.R.A., C.C.R.C.
Jackie Stader, C.O.T., C.C.R.C
Kimberly Turner, CMA, AS, BHS, CRA
Elizabeth Weeks-Rowe, LVN, C.C.R.A.
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Day 1: 8:30 a.m. – 5:00 p.m.
- What is Source Documentation and Supporting Source Data? Interactive exercise examining which documents are classified as source data, which documents are classified as source documents, and which documents are neither
- Review Roles and Responsibilities of creation, maintenance and monitoring source
- What are Required Quality Source Document Characteristics? Interactive exercise applying the attributes
- Developing a Source Documentation Verification Plan: Sponsor vs. Site. Collaboration
- Reviewing the Requirements of Electronic Medical Records and e-CRFs. 21 CFR Part II Compliant?
- Working with Auditors and Inspectors: Examination of FDA Warning Letters with Findings of Inadequate and Inaccurate Case Histories
- How to Document Deviations from Protocol and GCP: The role of notes-to-file and corrective action and preventative action plans
- Clinical research scenarios
- Simulations
- Critique of FDA Warning Letters
- Create a corrective and preventative action (CAPA) plan
- Source documentation best practice discovery session
Registration fees include assorted breakfast items that will be available each day ½ hour prior to the start of the seminar. Also included is a Networking Lunch that will be served each training day.
Special rates are available for multiple attendees from the same organization. Contact Elizabeth Andrews at 781-972-5418 to discuss your options and take advantage of the savings.
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Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 7 hours (0.7 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# 0778-0000-09-037-L04-P. Released: 10/09.
Hold this course at your company!
For more information, contact Naila Ganatra at (215) 413-2471.