Pursuit of a path from discovery to drug approval as quickly as possible is a…
1. Always know who is responsible for what task on the study
There is usually a designated main point of contact for the study and it is best to find out at the SIV if all communication should go directly through this person or if it’s preferred that the monitor directly contact the individual responsible for any particular task. Smaller sites tend to have one person who does everything for the trial. Larger sites with more studies will have designated staff for; sample processing, data entry, regulatory management, and patient interactions.
When communicating with a PI, find out if they prefer direct contact on an as needed basis or contact through appointments. When communicating through their administrative assistant, the PI should always be included.
2. Plan ahead and stay flexible
Monitors have the luxury of anticipating their schedule ahead of time. Often site visits are booked months in advanced and they rarely get the “Surprise, you have more work to finish by 5:00 PM”. Unlike site staff, who’s routine work can be frequently perturbed, for example when a trial patient suddenly crashes, requiring urgent actions and additional paper work.
With the COVID19 pandemic, there is added stress put on site staff, who try their best to follow study protocols while also following the continuously dynamic workplace. This reality means that sites have to take extra steps, learn new SOPs, and may not be on site daily. Documents may take longer than usual to get signed, queries may sit unanswered for a little longer.
Even outside of pandemic times, one site coordinator may have up to 12 studies to manage and one PI may have 20 studies to oversee. It is important for monitors to give site personnel ample lead time to complete tasks, with timely reminders for important tasks that requiring completion by an agreed upon, pre-set due date.
3. Find effective methods of communication that work best for your site
It is so important to understand the PI’s communication pattern. Some sites prefer to communicate exclusively through email and some sites prefer telephone. Different PI’s have different communication styles. Between taking care of patients and overseeing study staff, emails can quickly get lost in the shuffle of daily life at a site. For PI’s who are not responsive to emails, it is often best when something important arises to book an appointment for a call through their administrative assistant. Or to ensure the message gets through, to communicate instead directly with the study coordinator. Keeping in touch with the PI can be challenging and yet so important to maintain proper trial oversight by keeping them up-to-date.
4. Find common interests
Getting to know your site staff and finding a topic of conversation outside of that of the trial will make monitoring easier and more pleasant. Common interests like pets or favorite vacation spots can become conversation touch stones. Site personnel are more likely to remember a monitor when they feel a more personal connection with them. This human touch can help encourage speedier study task completion, and quicker responses to emails.
5. Be kind
Business experts understand the value of kindness at work. An article in The Harvard Business Review states that “Higher rates of [kindness] were predictive of productivity, efficiency, and lower turnover rates. When leaders and employees act kindly towards each other, they facilitate a culture of collaboration and innovation.” Another article from Forbes.com states that: “76% of people who experienced empathy from their leaders reported they were engaged compared with only 32% who experienced less empathy.”
Although the monitor is the leader and expert on the trial, monitors/CROs and the site staff work together in parallel and as a team. Often it may feel like the monitor is pointing out all of the site’s mistakes and this can cause a rift in the relationship between CRA and site staff. The monitor must always be careful not to use accusatory language. A great way of doing this is by stating that the monitor themselves may have missed something, instead of telling the site staff that they missed it. This empathic approach to communicating fosters an open conversation and leads to a swifter resolution of any issues that arise.
Did you Know?
Scimega clinical trial start-up times are 50% faster than the North American average, with premium quality data, and trial sites that are often among top enrollers in our Sponsors’ global oncology studies. Scimega consistently delivers expertise in oncology clinical trial services with a strategic focus on Sponsor program success. This caliber of performance holds true in the pre-pandemic, the new and the next normal context of oncology clinical research.
Contributed by: Lisa Ye, M.D., B.Sc., Clinical Research Associate