Locking a database in a clinical trial represents the milestone that the data is ready for analysis. The process that signals the data is ready starts from the first electronic entry of the data, and continues until all documentation is in place.
This webinar will review common best practices used to assure a timely and satisfactory lock process is in place and to ensure the procedures are documented for regulatory compliance. SOPs and tasks will be outlined to demonstrate database locking for both CDMS and EDC systems.
The first part of this webinar will review practices that may be started from study initiation that will allow for continued GCP and regulatory requirements at the actual lock. The topics in the second part of this webinar will address methods to assure that the data is valid and ready for analysis, while also covering the unlikely situation where a database might need to be reopened and how that may be achieved.
What You’ll Learn
Attendees will be able to:
1. Create database lock checklists
2. Understand the team involvement
3. Manage timelines and expectations
4. Understand regulatory guidelines
5. Prepare valid data for analysis
This webinar will introduce common best practice procedures to ensure a timely and valid database lock.
Maxine Pestronk has been in the Clinical Trial industry since 1993. Having worked for Contract Research Organizations, EDC Software, Pharmaceutical and Biotechnology companies, Ms. Pestronk has an array of experiences in the field of Clinical Data Management. Many of Maxine's years in the industry were in roles related to training of data managers; reengineering process for conducting studies using EDC systems; and demonstrating the usefulness of quality metric programs. Maxine has been a member of the SCDM Online Courses Committee since 2009, has authored 5 online courses and 2 Webinars.
Ms. Pestronk has a Master of Science in Computer Information Systems, is a Licensed and Registered Dietitian (RD / LDN) and is proud to be a Certified Clinical Data Manager (CCDM®).
Who Should Attend
Beginners to intermediate, CRAs and biostatisticians.
Participants are eligible to receive CEUs upon attendance and successful completion of a web-based assessment within 30 days after the webinar. CEUs are not granted after the 30-day assesment deadline. Each part of this 2 part webinar carries 0.2 CEUs.
SCDM is authorized by IACET to offer 0.2 CEUs for this program.