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Compliance with the 2017 changes to ClinicalTrials.gov registration can be time-consuming, as at least one organization has learned over the past year.
“A lot of institutions started to take notice after the update of the existing rule because it appeared that more attention was going to be paid to ClinicalTrials.gov,” says Brian Brotzman, CIP, senior compliance specialist and ClinicalTrials.gov PRS administrator in the human subjects office of the University of Iowa in Iowa City.
“Before the update to reporting requirements in 2017, there was not a lot of attention paid to ClinicalTrials.gov,” Brotzman says. “A lot of what was going on was under the radar, so we had to go back and look at the records and get those up to date and make sure people who were supposed to register knew they were supposed to register.”
The University of Iowa put Brotzman in the oversight role to ensure investigators complied with rules for registering with ClinicalTrials.gov, which opened in February 2000. The results database was opened to the public in September 2008. (View online at: http://bit.ly/2A6teGc.)
More recently, the Department of Health and Human Services (HHS) issued changes to a final rule that went into effect on Jan. 18, 2017. (Read more at: http://bit.ly/2QDe0Tz.)
The changes include specifying how to submit data and require there to be only one responsible party for submitting information about an applicable clinical trial.1
“We’re a community that works together,” Brotzman says. “When this new final rule came into effect and there was a lot more attention being paid to ClinicalTrials.gov registration, we did our background work. We looked into what the expectations were.”
They soon realized compliance work and oversight of more than 200 clinical trial investigators would require team effort. They formed a ClinicalTrials.gov working group with representatives from different departments.
Prior to Brotzman taking on the role of leading the working group, there were few procedures in place. “This was a whole new experience, so we could start from the ground up to get what we wanted, using the resources we had,” he says.
The work has paid off. The institution is now compliant with all legacy studies. The records, since the working group started, grew from 162 to more than 400, and most are in compliance. Records are up to date as well, he says.
“We had pretty good success across the board in getting things caught up and maintaining it,” Brotzman says.
Here is how the institution’s successful registration compliance strategies worked:
• Address departmental concerns. “We identified the current concerns regarding ClinicalTrials.gov registration and identified support from different departments,” he says.
Strategically, they approached departments that had researchers with the most studies registered on the government website. Then they asked the departments to nominate one or two people to help with compliance and to cover one or two hours of their time spent with the working group.
Department heads were eager to learn more about the initiative and contribute to the program, he notes. Those nominated would be members of the ClinicalTrials.gov working group.
“We worked with them and trained them on using the ClinicalTrials.gov system, and since then, they have been an invaluable asset,” Brotzman says.
Working group members educate researchers in their departments about the registration and provide help when asked, he adds.
“They’re training researchers that we otherwise would not be able to reach on a regular basis,” Brotzman says.
• Provide training on using the system. The working group’s initial training was on how to use the system, enter data, and respond to system users.
“We spent three months getting everybody trained and up to speed,” Brotzman says. “We met monthly after that to address ongoing issues and to continue to provide training as needed.”
Training included case examples. The working group also discussed ideas and solutions as they met, including any updates or news from ClinicalTrials.gov.
As working group members trained others on how to be compliant with the government website’s registration policies, they listened to feedback from investigators and reported on what they learned at the monthly meetings, he says. Working group members also stay in touch between meetings.
• Monitor registration compliance. One of the most common compliance problems involves investigators not registering as required on ClinicalTrials.gov, Brotzman says.
“This is probably consistent at other universities, as well,” he notes. “Another problem is when those who have registered are not keeping their records up to date and accurate.”
The 2017 final rule states that a responsible party has to register the clinical trial within 21 days after enrolling the first human research participant. The registration must include descriptive information, recruitment information, location and contact information, and administrative data elements.1
ClinicalTrials.gov also keeps a list of problems. Any registrations where the date has passed are automatically generated on the list. If an investigator has not updated the record within the past year, the research institution receives a notice, Brotzman says.
“As administrator, I oversee the entire registration for our institution,” he explains. “Anytime I see an issue come up, I communicate directly with the working group member who will take it to the department and address it there.”
Brotzman sends working group members daily messages, if needed. “Anytime a registration is not submitted on time or is not fully addressed, it is put on the problem list,” he says.
The working group found compliance problems that involved registrations that were accurate, but the researcher had not reported results as required. There were noncompliant studies completed years earlier and the investigators were no longer at the institution, he says.
“We had to track down the data and get everything back on track,” Brotzman says.
While the problem list typically has 50 to 60 records, most are for minor problems that can quickly be addressed, he adds.
• Submit checklist to IRB. The institution has a clinical trial checklist form that researchers complete and submit to the IRB with their research application after obtaining a ClinicalTrials.gov departmental liaison signature.
“It’s a robust form for the IRB to review before making their decision,” Brotzman says.
The following are some sample items from the University of Iowa’s form, which was adapted from ClinicalTrials.gov material:
- Is the study interventional (a clinical trial)?
- Is there at least one study facility located in the United States or a U.S. territory?
- Is the study conducted under a U.S. FDA investigational new drug (IND) application?
- Does the study evaluate at least one drug, biological, or device product regulated by the FDA?
1. Clinical trials registration and results information submission. Fed Reg. 2016;81(183):64982-65157.
Financial Disclosure: Author Melinda Young, Medical Writer Gary Evans, Editor Jill Drachenberg, Editor Jesse Saffron, Editorial Group Manager Terrey L. Hatcher, and Physician Editor Lindsay McNair, MD, MPH, MSBioethics report no consultant, stockholder, speaker’s bureau, research, or other financial relationships with companies having ties to this field of study. Nurse Planner Kay Ball is a consultant for Ethicon USA and Mobile Instrument Service and Repair.