Review and approval of drugs or devices by regulatory agencies requires the assumption that the data presented are valid and reliable. Integrity of the data is paramount to ensure confidence in the results and conclusions you will make.
This seminar is based on FDA E6 GCP Guidelines which are the basis of effective data quality management. Even if your research is not FDA regulated, the information you learn in this course will help to ensure a robust data collection and management plan. The information conveyed in this course will also assist investigators in setting up processes for smoother data monitoring and auditing.
Examples of CRF’s and required documentation will be presented. Data collection and preparation techniques will also be demonstrated. Additionally, this workshop will provide you with the knowledge and tools needed to assure a CDM plan that holds up when the inevitable deviations from protocol occur.
Who Should Attend:
Professionals in pharmaceutical, nutraceutical, medical device, clinical and biotechnology research who oversee or work with data collection and management will be benefited by this seminar.
- Study Investigators
- Data managers
- Data processors
- Site Personnel
- Clinical Research Associates
- Clinical Project Managers/Leaders
- Study Sponsors
- Clinical Research Organizations
- Clinical and Biotech Start-ups
- Individual researchers in health and biotech fields.
- Study Investigators
- Medical and Health Sciences
- Clinical Trials
- Clinical Research
- Medical Students
- Graduate Students in the Biological Sciences
- Staff in the above fields who work with data collection/management and require training in GCDMP
- Compliance auditors and regulatory professionals who require a knowledge of GCDMP in assessment of study protocols and reports
DAY 1 (8.30 AM – 4.30 PM):
Registration Process – (8.30 AM – 9:00 AM)
Session 1 – CDM: The Reasons and The Requirements
– GIGO = Garbage In, Garbage Out. Why we need good practices in data management
– Presentation and overview of FDA GCP Guidelines on data management
– NIH Policy (SOP 15, 17, 19)
– 21 CFR Parts 11, 312.62, 812.140
Session 2 – Elements in Developing a Data Management Plan
– Choosing a vendor and outsourcing
– Data privacy and protection of subject data
– Quality Assurance and Quality Control
– Monitoring and auditing of data
– Handling Errors and Corrections
– Storage and Transfer of Data
Session 3 – Study Set-Up
– Essential documents
– Prior to Study Commencement
– During Conduct of the Trial
– After Completion/Termination of the Trial
Session 4 – Study Set-Up (cont’d)
– CRF design and development (paper/e-CRF)
– Database build and testing
– Edit Checks preparation and testing
DAY 2 (8.30 AM – 4.30 PM):
Session 5 – Study Conduct
– Data Entry
– External Data integration and reconciliation
– Discrepancies, errors, corrections
– Data Cleaning (preparation) and Coding
Session 6 – Study Conduct (cont’d)
– (MedDRA and WHODDE dictionaires)
– Severe adverse events (SAE) status reporting
– Data Review and Quality Control
– Data Transfer procedures
Session 7 – Study Closeout
– SAE Reconciliation
– Quality Control
– Database Lock
– Electronic Archival
– Database Transfer
– Enhancing Reproducibility
Session 8 – Monitoring Visits
– What to expect during a monitoring visit
– Elements for Establishing a Corrective Action Plan
– Question and Answer Session
Dr. Marina Malikova
Ph.D., MSci, MA, CCRA, RAC
Dr. Marina Malikova has over twenty years of experience in the clinical research field. She has managed Phase I – IV studies involving investigational drugs, devices and biologics. She has worked on Industry-sponsored and Investigator-initiated trials in the fields of Surgery, Cancer Diagnostics and Interventional Radiology.
Dr. Malikova graduated from the Institute of Biochemistry, Russian Academy of Science, in Moscow, Russia with a PhD in Biochemistry. She also holds a Master’s Degree in Clinical Investigation and Project Management Certification from Boston University.
In her current role as Executive Director, Dr. Malikova manages research efforts in 13 divisions of the Department of Surgery at Boston Medical Center. She is responsible for clinical trials and basic biomedical research operations, quality assurance, risk management, safety monitoring, strategic planning, and macro-management of research programs. She provides guidance and oversight to the Project Managers, Clinical Research Associates (CRAs), Clinical Research Coordinators (CRCs), and laboratory staff. She advises faculty/staff on protocol and informed consent writing; assists with BU IRB applications and submissions; provides oversight for data user agreements, cost coverage analysis and budgets development, contracts and licensing for clinical research; and ensures compliance.
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