Welcome, VICTAS Sites!
The project team is hard at work setting up the VICTAS trial. We are currently developing the electronic case forms, identifying sites, developing training materials, and doing all the other many tasks that will be needed to undertake this clinical trial. We'll post more information here soon so be sure to subscribe to this blog to receive update notices.
The graphic below shows some of the activities we need to complete before we GO LIVE.
GO LIVE is when we'll start setting up sites. So far, we have 10 confirmed sites but we are planning to activate about 24 sites. The confirmed sites are:
We intend to get each site activated within 90 days. The graphic below shows the site startup process. In the first 30 days, sites will submit the protocol to their IRB for a local context review (Hopkins is serving as the central IRB). This is also the time to submit the study contract for approval. The second 30-day period is for collecting all the essential documents. The third 30-day period if for completing the study training. At the end of the 90-day period, we will activate the site to begin enrollment. Selected sites will be contacted soon to start this process. Stay tuned! Meanwhile, we look forward to working with you on this exciting new clinical trial.
Here is an initial project timeline for the first cohort of 500 patients. Subject to efficacy and safety results, the trial may be extended to 2000 patients and up to 30 sites.