Maintaining the accuracy and adequacy of clinical trial documentation is both a critical component of Good Clinical Practice and a challenge in today’s rapidly changing clinical research environment. In this workshop, learners will focus on the regulatory requirements and practical implementation of three key study documentation components: electronic health records, essential documentation in the site’s study file, and Notes to File (NTFs).
Increasingly, investigative sites are using electronic health records for all or part of their case histories. The FDA’s expectations for source data quality, 21 CFR Part 11 compliance, and monitors’ direct access to case histories present challenges for the use of electronic health records. This module will provide some practical solutions to meet these challenges.
Understanding the big picture of how essential study documents impact the approval and ethics of a clinical research trial often gets overlooked in the rush of document collection and requests. The foundation of this module is the identification of required documents in the site study file. Participants will acquire a practical understanding of how these documents provide evidence for the regulated activities of the investigator, the sponsor, and the IRB/IEC.
The use of Notes to File, or Memos to File, has become a relatively common practice in both sponsor and site files. Regulatory authorities, however, have questioned the utility of these documents in a quality systems approach to clinical trial documentation. This module will provide an understanding of the right questions to ask to determine if an NTF is acceptable and the components of a quality NTF.
- Describe regulatory expectations for quality source data and electronic records
- Implement contingency planning for source document deficiencies
- Effectively manage site and sponsor activities regarding electronic health records
- Recognize the role of essential documents as evidence for completion of regulatory responsibilities and quality study conduct
- Evaluate essential documents for GCP compliance and standards
- Apply best practices for essential document review and handling
- List the questions one should ask when determining the appropriateness of an NTF
- Identify the appropriate use of NTFs in both patient-related and study-related situations
- Write an effective NTF for an applicable site management scenario
- Clinical Research Coordinators
- Clinical Research Associates (CRAs)/Monitors and CRA Managers
- Project and/or Study Managers
- Project and/or Clinical Trial Assistants
- Quality Assurance Personnel
Linda Carter, R.N., B.S.N.
Nikki Christison, B.S., C.C.R.A.
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Day 1: 9:00 a.m. – 4:00 p.m.
Electronic Health Records
Notes to File
- Evaluate the characteristics of a simulated electronic health record environment for Part 11 acceptability and quality data standards
- Participants should come prepared to use the guidance and tools from the course to design a risk-based monitoring strategy and contingency plan for a current work situation
- For each required essential document, attendees will identify its role in documenting a particular research partner’s regulated responsibility
- Learners are encouraged to bring specific work-related document samples, process maps, checklists, etc., and will have the opportunity to evaluate these in light of best practices and GCP standards
- Review several scenarios and associated NTFs, and evaluate if the NTF was the most appropriate manner for managing and documenting the issue
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 April Van Dam 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 6 hours (0.6 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# 0778-0000-13-015-L01-P. Released 3/13.
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For more information, contact Naila Ganatra at (215) 413-2471.