R&D center adapts for multicenter studies

As a research institution's human subjects research increases, so must the work. In some cases this work means expanding to handling multicenter protocols, which might result in new challenges. For example, the review board handling these multicenter studies will need to provide some guidance on regulatory and human subjects protection issues to the satellite sites.

Review board offices will need to develop new policies and procedures, as well as staff roles and tasks to handle the influx of new work that comes with multicenter protocol reviews, an expert says.

"At our site, these types of studies have been increasing for the past 10 years," says Stephanie A. Skoler-Karpoff, MPH, manager of the Research Support Office in the Office of Clinical Research at Memorial Sloan-Kettering (MSK) Cancer Center of New York City.

In 2000, Memorial Sloan-Kettering had two studies in which a Memorial Sloan-Kettering investigator wrote the protocol for a multicenter study. By 2010, there were 87 such studies, Skoler-Karpoff says. "Every year these increase, and there are a couple of reasons," she adds. "We can accrue subjects faster and get results to transfer into practice faster."

MSK opened its Office of Clinical Research's multicenter protocols group (MCPG) at the end of 2009 to provide this guidance and support.

"Our goal for starting this office was to provide institutional support and a repository for all of the common tools and best practices involving oversight, safety, and compliance," Skoler-Karpoff says.

Multicenter studies require more resources and staff time than single-site studies, she notes. Having a specific office handle the training and oversight of these studies can result in improved regulatory compliance and reduce duplication of effort, Skoler-Karpoff says. "In addition, people are just happier, having a central place to ask questions about multicenter studies," she adds. She describes how oversight of multicenter protocol reviews works:

Develop new standard operating procedures (SOPs). Research oversight and review board offices will need new SOPs to describe regulatory requirements for multicenter study principal investigators (PIs) as well as for participating sites.

"We developed an institutional SOP that defines the responsibilities for the PI, describing what the PI's responsibilities are in a multicenter study," Skoler-Karpoff says. "It sets requirements for document language and submissions."

The SOP also sets regulatory and data submission timelines, such as describing when researchers have to submit data and amendments, she adds.

Create training module. Skoler-Karpoff provides training and inservices based on the SOPs.

The training sessions last an hour and are held regularly because there are new multicenter studies beginning on a regular basis, she says. Research staff also has access to tools and templates that help reinforce the training.

Use standard protocol language. Research sites that are part of a multicenter study need to use some of the same language for therapeutic and non-therapeutic studies, coordinated by Memorial Sloan-Kettering Cancer Center. For example, sites should include language pertaining to deadlines of when data and the case report forms (CRFs) are submitted, Skoler-Karpoff says.

"We have something posted on our web site that is our suggested language, and they can cut and paste these to the protocol," she says. "This way the site will know exactly what our expectations are."

Collect best practices. "One thing we're doing is collecting all regulatory documents, IRB documents from outside institutions, including their informed consent form, continuing review approvals, and amendments," Skoler-Karpoff says.

Also, MSK has an intranet page that posts best practices, definitions, and templates that are useful in multicenter protocol management. "We created processes and guidelines for sites," Skoler-Karpoff says. "We have guidelines for auditing participating sites and best practices for communication."

Also, there is a computerized graphic presentation available to use at start-up meetings, she says. "It's a skeleton that they can fill in with details as needed, so it's a lot easier for them, and there is no reason to reinvent the wheel," she adds.

Track each site's protocol life cycle. "We have a sophisticated system that tracks all review board documents, including serious adverse events [SAEs], and other data, and it's available for all research studies," Skoler-Karpoff says. "The system, which was not part of the multicenter initiative, allows us to see each site's information, including their accrual information."

The tracking system also allows the oversight office staff to look at the study's latest amendments and continuing review data. And it can send out automatic e-mail reminders to the different sites about upcoming deadlines. "We can see all the documents associated with that [review board] approval, any correspondence and documents," she says.

The system will show the timeline for each site's local review board approvals, and it e-mails the MSK oversight staff information about continuing reviews. "It will send an e-mail to me that says, 'In 30 days, this institution's site's [review board] approval is expiring,'" Skoler-Karpoff says.

The tracking system also enables oversight staff to easily look up the names of consenting officials at each site, which saves them the time and trouble of calling coordinators for this information, she adds. Investigators benefit from this assistance.

"We remind them each week of documents that are pending and need to be submitted for approval," Skoler-Karpoff says.