Clinical trials training program wins award

Coordinators, investigators offered different tracks

It started with the research nurses but soon other staff involved in clinical trials wanted to take part in the comprehensive training program being offered at The University of Texas M.D. Anderson Cancer Center in Houston. Last year, the clinical research training program received the 2003 award of excellence for best practice from the Bethesda, MD-based Health Improvement Institute.

"We did surveys and had good feedback about the education, and the question people asked was, Why not the faculty?’" says Kristin Bialobok, RN, CCRC, CCRA, director of clinical research compliance at the center. Therefore, the center proposed a faculty education program that would require people to sit in a class setting for five two-hour modules, she says.

The lecture sessions were kept small with no more than 50 people, and the educators are clinical research compliance staff, nurses, clinical trials monitors, and trials auditors, Bialobok reports.

"Each module has a competency test of 20 questions; in order to pass the module, you have to get 85% or better on the competency test," she explains. The investigator training consists of five two-hour modules, which are as follows:

  • Module 1: Research ethics, history of the IRB, and conflict of interest.
  • Module 2: Responsibilities of the investigator, the M.D. Anderson review and approval process.
  • Module 3: Informed consent process, institutional research databases, and compassionate use of drugs.
  • Module 4: FDA inspections, institutional audit process, investigational new drug (IND), and federal regulations on IND policy.
  • Module 5: Tips for writing a protocol, source documentation, and adverse events.

More than 800 faculty members and fellows have completed the program, Bialobok notes.

The cancer center has made it a policy that new faculty members and fellows are not permitted to participate in research activities until they have documentation that they have completed their courses, she says.

"We have flags in place so if a researcher submits a protocol, and the training isn’t listed as completed, then the protocol cannot go through the process," Bialobok adds.

The M.D. Anderson Cancer Center educational program has an option for investigators who think they know all the information and should not have to sit in the classroom, she says.

PIs can take a computerized version of the education session tests without attending classes, Bialobok says.

"We have the test set up so a person couldn’t access any other information and either knows the answers or doesn’t," she explains. "If a person chooses to take the test, but doesn’t score at least 85%, then the person has to go back and take the class that corresponds to the module he or she failed."

"People who failed had to come back, and then we do one session with them, review the information they missed, and they take the test again," Bialobok says.

Since the cancer center started faculty training in September 2002, requiring all faculty to complete the test within one year or before beginning research in the case of new hires, very few have opted out by taking the test, she reports.

Future plans may include ongoing education sessions, Bialobok notes.

"We’re assessing that right now," Bialobok says. "We have focus groups and needs assessment projects to see where we need to go from here: What do we perceive as the faculty’s needs, and what do they perceive as their needs?"

Eventually, there probably will be an annual refresher course, but it’s yet to be determined how this will work, she says.

More in-depth study available

Clinical staff training is more detailed than what the investigators receive and includes seven modules lasting a half-day each. These are broken down into the following topics:

  • Day 1: Overview of clinical research compliance department, research team roles and responsibilities, elements of a protocol, and clinical research design.
  • Day 2: Research ethics and history of the IRB, scientific integrity, conflict of interest, informed consent, responsibilities of the investigator, and M.D. Anderson protocol review and approval process.
  • Day 3: Tips for writing a protocol, adverse events, compassionate use of drugs, FDA inspections, institutional audit process, FDA regulations, and INDs.
  • Day 4: Institutional research databases, including what they are and how to use them; how to submit electronic documents, and source documentation.
  • Day 5: Community oncology program, studies sponsored by the National Cancer Institute (NCI), differences in sponsor requirements, and tour of the investigational pharmacy.
  • Day 6: Overview of statistics, monitors and sponsors, Clinical and Translational Research Center (CTRC), which is a place where investigational drugs are administered and which is set up to deal with protocols; chart manager system, which explains how to order charts in the institution’s system; research nurse development model training, including a look at the career ladder and how it works.
  • Day 7: Study management, research charge ticket, protocol cost analysis, contract budgets, and outpatient documentation.

Since word has spread of the cancer center’s comprehensive training program, there have been calls from institutions around the world to learn more about it, Bialobok notes.

"We’ve had people from Japan and China who were here and wanted to know how to set up programs similar to what we have at M.D. Anderson Cancer Center," she says.