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CR education: From AEs to recruitment
Everything taught over five half-days
A research university has found that a five-session program provides the right mix of clinical research introduction and education.
"It was called the study coordinator course, but we wanted to make it clear that we wanted junior investigators and others to attend," says Susan Sonne, PharmD, BCPP, an associate professor of psychiatry and pharmacy at the Medical University of South Carolina (MUSC) in Charleston, SC. Sonne also is the chair of the MUSC IRB 2 and co-director with Tom Heusey of the Clinical and Translational Research Center (CTRC).
Called the core clinical research training (CCRT) program, the course is available to study coordinators, research nurses, regulatory specialists, principal investigators, and others interested in learning more about the clinical research process.
"In our last class we had 40 people registered for the course," Sonne says.
Even some experienced researchers, who serve as investigator mentors, have attended the class, partly so they will see what their trainees will learn, she adds.
While everyone involved in research at MUSC has to take a basic CITI training course, the CCRT is voluntary, and participants who complete it and pass the 50-question exam at the end receive a completion certificate, Sonne explains.
An IRB might require an investigator to take the CCRT as part of a remediation effort when there have been compliance findings during an in-house audit, but these are very rare, she adds.
"We've had the program for over three years and have trained more than 300 people," Sonne says.
The program — which is held 8:30 a.m. to 12:30 p.m. on five days over two weeks – is designed as follows:
• Day 1 — Good Clinical Practice (GCP): Sonne spends this whole first session reviewing human subjects research history, regulations, good clinical practice, and some of the major research ethical lapses that occurred 50 to 60 years ago.
"Part of this discussion is to give research staff a better understanding of why we have the rules," Sonne says. "In the past they focused on the research question and didn't pay attention to ethical considerations."
Sonne provides attendees with a few ethical scenarios and asks them what they might do in these situations.
And she emphasizes that she and others at the IRB are available to answer questions whenever an investigator or research assistant has an issue to discuss.
• Day 2 — IRB submission and standard operation procedures (SOPs): "One thing we like to do is an IRB application walk-through," Sonne says. "We have an experienced regulatory specialist who is used to accessing the IRB Web site, and this person has a computer out to show people how we do the initial application."
On the second day, the class also focuses on SOPs, what they are, how they might be helpful, and how to write them, Sonne says.
Operational SOPs might include the following:
- How do we recruit participants?
- What are we going to do in the trial?
- How do we set up a petty cash account?
- Where is the money kept?
- Who is responsible for petty cash?
"We go through some sample SOPs and discuss things like what if you change the rule during the course of the study," Sonne says.
Another module on the second day involves investigational drugs. "We talk about regulations around drug accountability and give some tips, telling them about our investigational drug services at MUSC," Sonne explains.
This module also covers what the Food and Drug Administration (FDA) requires for investigational new drug (IND) applications.
"We discuss packing slips and how you actually organize study medications, depending on how it comes to you," Sonne says.
A final module, led by the MUSC compliance officer, goes over self-audits and discusses preparing for audits and using a GCP checklist.
The checklist includes the types of standards that most auditors would look for, including these:
- Is the informed consent there?
- Does the site have training logs?
- Do they have an original copy of the informed consent?
• Day 4 — Informed consent, HIPAA & adverse events (AEs): "We talk about the informed consent process and HIPAA as they relate to research," Sonne says. "Our IRB does HIPAA authorization, and we talk about what they need to know."
Sonne tells attendees about basic informed consent rules and best practices, including describing how to provide the initial informed consent to a potential study participant.
"You give them a copy of the informed consent document to read and put them in a quiet room where you'll leave them alone," Sonne says. "Then you check on them and when they're finished reading you ask them if they had a chance to read the document."
Sonne suggests researchers ask potential study participants what their general understanding is of what the document says.
"This way you'll know the level of detail you need to talk about for the rest of the informed consent process," Sonne says. "Make sure people understand that informed consent is something that occurs at every single visit, and it's a continuous process."
On the fourth day, Sonne also talks more specifically about the IRB and different levels of review, including exempt, expedited, and full board reviews.
"We talk about what the requirements are and how you decide where the application fits within those review types," Sonne says.
A regulatory specialist will discuss how to manage regulatory binders.
"We talk about how to organize all that stuff and what you need to keep and what you don't need to keep," Sonne explains. "And if you have obsolete stuff, then you shouldn't throw it away because you can have a binder for the obsolete items."
Also, the binders should include all sponsor correspondence.
Another module involves adverse event reporting.
"You could spend a whole day on this, but we have 1.5 hours of it," Sonne says.
This module, led by the director of the university's new research help desk, covers what is reportable as serious adverse events at MUSC.
"We offer different scenarios, showing what study participants say at the study visit and ask what the AEs are," Sonne says.
The fourth day's instruction then moves to recruitment and retention issues.
It focuses on how to determine what your target audience is and the characteristics of a good recruiter.
"A good recruiter is someone who is personable, who likes talking to people, and who has a little salesmanship or cheerleading ability," Sonne says.
"Someone who is drab and doesn't like to talk to people won't be able to recruit," she adds. "We need someone perky and energetic."
Some trial sites try to rely on provider referrals to enroll their studies, but experience at MUSC has shown that this doesn't work, Sonne notes.
Their colleague doctors have other priorities and typically don't remember to send patients over to a researcher's office, she adds.
"You need face-to-face interaction with potential participants," Sonne says. "The best thing is to have direct patient access to people who are potential study participants."
One way to do this is to set up a booth in a clinic lobby. Or trial sites could advertise to potential study participants.
"We talk about what kind of ads might work best," Sonne says. "Sometimes it's radio or television, or it could be the newspaper where you put in an ad."
Investigators and research staff also could take advantage of unique marketing opportunities, such as running ads on the weather station during hurricane season when everyone tunes in, she adds.
"We also talk about how you need to pay attention and track that method, and if it doesn't work, you should try something else," Sonne says. "And we talk about how all recruitment methods need to be IRB approved."
The ads need to be approved, and if the study includes having trial staff call potential participants, then the verbal script needs to be approved by the IRB, she adds.
The last part of day four focuses on research misconduct, a module that's taught by staff in the research integrity office.
This module focuses on defining, identifying, and reacting to research misconduct, Sonne says.
"The instructor might give the class a vignette and ask them what they think of this," she adds.
In one example, basic scientists might ask their laboratory staff for blood samples to use in their research, Sonne says.
"What are the issues there? Is it okay to ask your staff for the blood samples, or if it's not, why not?" she says.
"We also need folks to know that if they feel uncomfortable with something going on in the study they're obligated to report it and can report it anonymously, and there's a hotline for doing so," Sonne adds.
• Day 5 — Exam and budgets: Most of the last day is spent on the two-hour exam, Sonne says.
"We also talk about the research support desk, called the Success Center," Sonne says. "The Success Center's staff will come in so everyone can meet them, and they explain what they do and how they can help research staff."
Also, a representative from the Association for Research Professionals in the Low Country comes in to talk about the association and benefits of joining it.
"And depending on our class audience, we might offer a little section on budgets," Sonne says. "We tell them how there are regulations for how to spend research dollars and how it's better to ask permission than forgiveness."
The exam period includes a 15-20 minute review. The exam itself is designed to cover practical information, as well as to assess whether attendees understand the big picture in human subjects research, she says.
"It's a 50-question, true and false or multiple choice test," Sonne says. "It's a minimum competency exam, and a score of 75% is passing."
["Regulatory Documentation" chart inserted in this issue. Source: Vanderbilt University, Nashville, TN.]