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6-Hour Virtual Seminar on Clinical Data Management – Part II
May 17 @ 8:00 am - 2:00 pm CDT$545
A data management plan or DMP is a formal document that outlines how data are to be handled both during a research project, and after the project is completed. The goal of a data management plan is to consider the many aspects of data management, metadata generation, data preservation, and analysis before the project begins; this ensures that data are well-managed in the present, and prepared for preservation in the future.
Study start up activities include designing case report forms (CRFs), paper or computer; specifying cleaning rules (edit checks); building and testing the database; and releasing the study database to collect data.
Study conduct activities include collecting the data on CRFs and via electronic files, cleaning that data, managing adverse event and serious adverse event collection, and producing reports.
Study closeout focuses on ensuring the data is complete and of a quality to support final analysis.
Study monitoring is an in-person evaluation carried out by sponsor personnel or representatives at the sites at which the clinical investigation is being conducted. On-site monitoring can identify data entry errors (e.g., discrepancies between source records and case report forms (CRFs)) and missing data in source records or CRFs; and assess compliance with the protocol and investigational product
Why you should attend
At the end of this class (Part I & Part II) attendees will be able to:
- Define best practices as they apply to CDM processes
- Describe CDM processes from study start-up to database lock
- Apply best practice rationale when assessing data collection requirements/instruments
- Evaluate the benefits of standardization in establishing CDM processes
- Discuss current technology/methods of data collection and associated documentation
Who Will Benefit
- New or aspiring Clinical Data Managers
- Clinical Data Managers
- Data Coordinators
- Clinical Research Associates
- Data Management Personnel
- Project Managers
- Government employees at clinicaltrials.gov