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Major research organization fine-tunes the site start-up process
Study start-up time dropped whopping 41%
Duke Clinical Research Institute (DCRI) in Durham, NC, has implemented a site start-up team process that quickly shaved 77 days off the amount of time between when the regulatory packet is sent to the trial's activation.
Pre-2008, the start-up time was 186 days. After the DCRI began its site start-up team process, this dropped to 108 days. The 41% decrease in time occurred within a year of DCRI's launch of the new process, greatly exceeding the team's goal of a 10% decrease, says Jennifer L. Peterson, clinical trial manager, site start-up, DCRI.
The site start-up team makes the new study a priority at sites and assists them with a coordinated effort.
"You can shave off time if you concentrate on identifying hurdles and seeing what you can do to streamline the process, Peterson says.
As the world's largest academic research organization, DCRI's success likely will catch other research institution's attention and show sponsors that increased resources at the site start-up process can result in huge benefits.
"The study start-up phase is key," Peterson says. "It's important to streamline it from the beginning because it sets the pulse for the study."
Here's how DCRI implemented the process and achieved the positive outcomes:
Form a study start-up team: The study start-up team's role is to communicate with trial sites about the timeline for submissions and meeting regulatory requirements.
The team also builds trust with study coordinators and investigators and makes expectations and deadlines clear to everyone. The team establishes accountability and improves communication.
"We knew this process would increase efficiency at the site," Peterson says. "We wanted to make sure our faculty principal investigators were comfortable with this new model, which is the reason why we put together the site communication plan."
Customize a communication start-up plan: "One thing we found that worked well is having a customized communication plan with the site, especially with study coordinators," Peterson says. "It's always easy to say the staff at the site is 100% dedicated to the study, but in reality study coordinators might be doing clinical rounds and have other studies and priorities."
The customized start-up communication plan asks coordinators how they wish to be contacted, whether by telephone or email. It also asks these questions:
When will you be able to respond to the study start-up team's requests?
When is it a good time to call coordinators to discuss the study?
What is your schedule?
"We ask for a commitment of how much time each week they can spend on this study," Peterson says. "Then we work closely with that particular site, respecting the study coordinator's time."
The communication plan is customized for each study with information from the site specialist, who puts in protocol information. Sponsors can see the plan upon request.
It's a part of the standard process, and it's created from a one-page template. (See sample communication start-up plan, below.)
The purpose of the plan is to establish a collaborative relationship with study coordinators, while making certain that the study remains a key priority and deadlines are met.
All of the communication questions answered by coordinators will be documented in the plan along with deadlines. This way the study start-up team knows when to call and check on reports and data.
Put escalations in place: If a site doesn't meet its deadline or isn't responsive to sending in documentations, then the case is escalated. The study start-up team will find out what is causing the hold-up and address the problem.
For instance, it could be the study coordinator just had his or her work hours cut to part-time due to the organization's budget cuts.
The solution would be to re-establish the site's communication plan to accommodate the coordinator's new schedule, Peterson says.
"As long as we have reasons for why the site is not being responsive, then we can resolve it," Peterson says. "It could be the site has just gotten another study and we need to help them prioritize effectively."
Make seamless transfer to monitoring: The study start-up team's work is done with the site has begun enrolling subjects. But rather than stop contacting the site abruptly, the team helps the site make a seamless transition to the clinical research associate's monitoring process.
"We hand over the site communication plan because it's important, historic information the monitors can use as well," Peterson says.
The monitor will call the site coordinator to confirm the plan's details, saying, "Hi, I see you worked with Jennifer in start-up. Does it still work best to call you on Wednesday from 10 to 2 p.m.?" Peterson says.
"This keeps the site from feeling like the process is compartmentalized, and now they'll have to start over," she adds.
Study start-up site communication plan
DCRI shares template
The Duke Clinical Research Institute (DCRI) of Durham, NC, has developed a site start-up team communication plan that is customized for each study. The plan's goal is to improve communication between study coordinators, principal investigators, and the site start-up team.
Each communication plan is developed from a brief template that asks for basic information from the site. DCRI's site communication plan includes these items:
Site Regulatory Contact
Site legal document contact