Study Go Live is always an intensive and sometimes even chaotic. That being said there are ways to compensate for last minute changes and setbacks. A few simple techniques can ease the go live anxiety however; we’ll go over them below.
1. Use a go live checklist; make sure your IRT vendor has one to go by for your study. The go live checklist should include things like drug management and data transfer scheduling, report recipients, screening and randomization limits. A list like this can make sure that any settings used in UAT have been correctly configured for the live environment.
2. Make sure your site shipping addresses are 100% correct prior to site activation. This will ensure that the IRT system generates the shipment request to the depot with accurate information. This is especially important if you have cold chain supply in 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.
3. Speaking of shipping, plan a conference call with your depot and IRT vendor to track initial shipment requests from the IRT through the depot for the first few sites activated. This will ensure 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.
4. Use a newsletter: Reinforce things like having PI’s log in to the IRT in case they need to emergency unblind a subject. Many PI’s don’t use the IRT until they are forced to and this can create problems if a subject is in need of an immediate unblinding. Also use the newsletter to remind site staff how they can request access for new users that come on board at their sites.
5. Web Reports: Make sure your sponsor team members are familiar with the IRT web reports 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.
One of the worst things you can do is think that once the IRT system goes live, that the tricky part is over. To the contrary, the tricky part starts when new systems start moving study drug and randomizing subjects.
When Go Live is managed carefully and the common pitfalls identified and mitigated, it can be a smooth and efficient exercise. Some of the tips above may not apply to every study every time; however, they are a good baseline to use to think critically about Go Live.