September 10, 2012

Advanced EDC Trials: The Team is Working Together, Now Get Ready for Change

Advanced EDC Trials: The Team is Working Together, Now Get Ready for Change

At this stage of the clinical trial, the Sponsor has initiated sites, patients are being screened, enrolled, randomized and treated. The CTM and CDM group are completing their tasks smoothly. When things are running smoothly, no thoughts are given to fine-tuning the system to how users interpret the protocol or how the system is used across different sites.

Then comes the dreaded protocol amendment which may change everything that has been established: (i) inclusion/exclusion criteria, (ii) study assessments, (iii) treatment group assignment, (iv) interim analyses, to name a few.

In this 3rd of 4 webinars, we look at the impact of one or more protocol amendment(s) on the study database and the EDC team and how changes can be implemented smoothly and with minimal effect on the ongoing study.

Topics covered include:

• Typical protocol amendments and their impact on the study
• What and how the eClinical system can implement the changes
• What the EDC team needs to know and how they should be informed
• Timing the changes/deployment
• Monitoring the effect of the changes/deployment and finetuning

What you will learn:

• How to assess the risk/impact of one or more protocol amendments and the feasibility of pre-planning
• How to develop a deployment plan
• How to deploy protocol amendments through an EDC system to ensure data consistency across all sites/subjects
• What you need to pay attention to after each protocol amendment is rolled out

This webinar is Part 3 of a series on Advanced EDC Trials:

Clinical Operations, Clinical Development, R&D, Clinical Trials Project Managers, Lead CRAs

St. Clare Chung is currently Director of Bio-statistics & CDM at SCiAN Services headquarters located in Toronto, Ontario. She has more than a 20 years of experience in statistical consulting, clinical data management, data analysis and clinical report writing.

Ms. Chung is also one of the original developer's of SCiAN's paper and EDC data management systems and was involved in the concept, design and implementation o f the systems. Her research interests are in Bayesian designs for Phase I/II studies and survival analysis.

SCiAN - a science-technology based contract clinical research company (CRO) - provides e-clinical and EDC solutions and clinical data management systems and services to the healthcare industry for IND stage (phases II - III) clinical trials.