Session 9 - The last mile challenge - How to effectively manage post database lock changes?

  • #communicate
Monday, September 14, 2020: 9:30 AM - 10:30 AM
/ CEU Credits:0.2

SESSION CHAIRS & SPEAKERS

Speaker
Cecilia Calcagno
Lead Clinical Data Manager
MSD Argentina
Session Chair
Hui Tanya Sun
Principal Lead Data Manager
PRA Health Sciences
Speaker
Sarah Ezzi
Clinical Data Manager
Westat

SESSION DESCRIPTION 

Locking a clinical database and moving into the data analysis phase has always been a big milestone in clinical trials. In the ideal world, once a clinical database is locked, it goes smoothly to the data analysis phase without any additional changes made. However, in reality, most of us have come across scenarios such as new clinical data are identified, additional queries need to be issued, or more external data sources await uploading after a database lock. Thinking of running a clinical trial as running a marathon, post database lock changes are like the final hurdles on the last mile before the glorious finish line. It is important to develop a strategy to manage the post database lock changes in a cost-effective manner. Post database lock changes are caused by different reasons and should be handles differently. Depending on the critical level of the post database lock changes, some changes may have to be corrected while others may only need to be logged/noted. The final decision on how to manage a post database lock change depends on a lot of factors. As for a Data Manager, it is our responsibility to propose the best way to handle a post database lock change considering different contributing factors including but not limited to timeline, quality, cost and budget.

The goal of this panel session is for the panelists and the audience to share their real-life experience on how to effectively manage different types of post database lock changes. Panelists will discuss topics such as what factors contribute to a post database lock change, how to avoid the post database lock changes if possible, how to minimize the negative impact of the change on quality of the data and progress of the study if the changes are not avoidable, and various cost-effective ways to manage post database lock changes based on lessons learnt from other Data Managers. After this session, the audience should be able to carry out an intelligent discussion of post database lock changes with the study teams as needed and implement certain measures to eliminate or reduce the negative impacts of post database lock changes on the quality of data. The Data Managers should be equipped with the knowledge shared at this session to lead the study team to successfully overcome the final hurdles on the last mile of this marathon of a clinical trial. 


TOPIC


LEARNING OBJECTIVES

1. The Clinical Data Manager will understand the types and causes of different post lock data changes.
2. The Clinical Data Manager will be able to proactively propose cost effective methods to reduce the number of post lock data changes.
3. The Clinical Data Manager will be able to identify the most efficient way to manage post lock data changes.

Handout(s)


SESSION INFORMATION

CDM Certification Competencies::
Project Management,Data Management Plans,Data Base Lock Procedures

Target Audience:
Study Data Manager,DM Management,Statistician