Study Go-live for interactive response technologies (IRT), (IRTor IxRS) is always a rigorous process.That being said, there are always ways to compensate for last minute changes and setbacks. The following simple techniques can ease any go-live concerns:
- Go-live checklist: Use a go-live checklist to ensure your interactive response technologies vendor has one to utilize for your study. The Go-live checklist should include things like drug management and data transfer scheduling, report recipients, screening and randomization limits. An inventory list can make sure that any settings used in UAT have been correctly configured for the live environment.
- Shipping addresses: Ensure your site shipping addresses are 100% correct prior to site activation. This will confirm that the Interactive Response Technology (IRT) system generates the shipment request to the depot with accurate information. This is especially important if you have cold chain supply within your study. Keep in mind that the shipping and receiving address for a site may not be the location where the subjects’ visits will occur.
- Initial conference call: Plan a conference call with your depot and IRT vendor to track initial shipment requests from the Interactive Response Technology (IRT) through the depot for the first few sites activated. This will guarentee that the orders are received and processed by the depot correctly. It’s cheap insurance against any initial shipment settings that may be incorrect at the time of go-live.
- Use a newsletter: Besides acting as a vehicle for updates on the trial, a newsletter helps reinforce positive activity by the site users. For instance it motivates PI’s to log in to the IRT. Many PI’s don’t utilize the IRT until they are required to and this can create problems if a subject is in need of an immediate unblinding and the PI is comfortable logging in. Also use the newsletter to remind site staff how they can request access for new users that come on board at their sites.
- Web Reports: Make sure your sponsor team members are familiar with the IRT web reports and the clinical trial software so they know where to find critical site and enrollment information. This exercise will also ensure that each team member has the most appropriate access for the live system.
When Go Live is managed carefully and the common pitfalls identified and mitigated it can then be a smooth and efficient exercise. Some of the tips in this blog may not apply to every study every time however, they are a good baseline to use in thinking critically about Go Live. Once you Go-live is complete, other challenges may arise. Activating clinical sites and implementing a new system will begin movement of a study drug and randomizing subjects. We will discuss techniques in managing this activity efficiently in upcoming blogs. Until then check out our IRT offering here.