Full course description
In this course, critical concepts and practical methods in the planning, collection, storage, and dissemination of high-quality, reliable and statistically sound data will be discussed. Topics include how study design and case report form (CFR) specifications impact data quality, utilization of data quality indicators, and good documentation practices.
- Case studies: In search of the ‘truth’. The importance of quality at the data level.
- What is Data?
- The scientific method
- Quality Control
- Good Clinical Practices (GCP)
- 21 CFR Part 312 and 21 CFR Part 812
- ISO 14155 - medical device studies
- ICH E6 – drug studies
- Clinical Investigational Plan (CIP)
- Case Report Forms (CRF) specifications
- Variable consistencies
- Source data accuracy
- Transcription errors
- Case studies review
- Data quality indicators
- Monitoring action items
- Case studies review
- Principals of Good Document Practices (GDP)
- Three take-aways
Cheryl Hergert, MPH, has more than 20 years of experience working with start-ups as well as corporate groups. Cheryl is familiar with product development for medical devices, pharmaceuticals and combination products. Her experience ranges from FDA panel presentation and approval to company closure, product feasibility testing to product launch, domestic product launch as well as European Union price negotiations. She has held positions in Regulatory Affairs, Quality & Compliance, Clinical Affairs & Operations, Data Management, Statistics and Medical Writing. She currently works for Medtronic as a Principal Clinical Quality Specialist overseeing the quality and compliance of the diabetes clinical program. Patient advocacy drives her work in quality and compliance. Her research interest includes patient data privacy and the impact of regulations pertaining to data privacy on innovation and patient participation. How regulations impact movement of clinical data, the design and implementation of clinical research in multi-regional studies, and patient consent are of interest.
Learner Level: Beginner
This symposium is designed for Clinical Research Assistant/Associates or Clinical Research Coordinators in academia, clinics, hospitals, industry, or CRO with 1- 2 years of clinical research experience. Individuals may be new to clinical research with limited knowledge of clinical trial conduct, good clinical practices, regulations and common terminology associated with clinical research.
Emory Nursing Professional Development Center (ENPDC) is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center's Commission on Accreditation. Attendees to this CNE activity will be awarded 1.0 Continuing Nursing Education contact hours from ENPDC.
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