Toronto, Canada (PRWEB) September 07, 2012
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.
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
For more information or to register go to http://xtks.in/xto-503.
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Karen Lim (416) 977-6555 ext 227