Six steps to compliance monitoring success

'Senior faculty need to get on board'

The Office of Protocol Research of the University of Texas M.D. Anderson Cancer Center in Houston developed its administrative research-monitoring plan (ARMP) as a simple, user-friendly systematic tool.1 The idea is to show research sites the main objectives they need to create their own ARMPs while allowing them flexibility in the details.

Here are the six steps needed to create an ARMP:

• Step 1 - Perform a department profile assessment: "This should be done by a department chair or administrative director or department manager," says Marion Olson, CIP, research regulations supervisor in the Office of Protocol Research.

This step entails reviewin g the type of research conducted by investigators, defining investigator qualifications, setting research goals, outlining research vision, and identifying challenges unique to the department.

• Step 2 - Perform an assessment of the department's research resources: "They need to review the type of research they're going to do, the qualifications of investigators, the department's vision and goal," Olson says. "Also, look at the funding sources and education required for research staff."

This assessment should include gathering critical information and buy-in from senior leaders in the department, she adds.

"The senior faculty need to get on board and provide input on how the ARMP is developed," she says.

• Step 3 - Develop a department monitoring plan: "This lists the nitty gritty of what needs to be in the ARMP," Olson says. "It should include the informed consent process procedures, making sure informed consent is documented appropriately and that they're following the process."

In addition, step 3 includes determining the study's risk, number of subjects, subject population, complexity of research design, and number of study locations.

There should be a procedure for handling unanticipated problems (UPs) and details about the institution's policies for reporting time frames, she adds.

"They should have procedures on how to handle violations or issues that impact research and how the process will occur," Olson says. "You need to address these issues across the board."

The ARMP also should define procedures to enhance data integrity.

Another aspect to consider is how research studies will be monitored if they're conducted at outside sites.

"Because this is such a large institution, a lot of departments will do multi-site studies where we're the lead site," Olson says.

The ARMP in step three also needs to discuss standard operating procedures (SOPs), checklists, delegation log templates for studies, and other aspects of human subjects research, she adds.

• Step 4 - Define an implementation strategy: "This is where the department would submit the administrative research monitoring plan to the IRB for review and approval," says Evanna Thompson, MPH, CIP, a research regulations supervisor.

"Once the plan is reviewed and approved, communication is reported back to the responsible person in the department, who should then inform the research staff of the department's expectations," Thompson says.

Research officials can take steps to review the ARMP, resubmit the plan, and then revise.

Specifically, step 4 entails determining how to provide for continuous re-evaluation of the plan, identify responsible staff for regulatory monitoring, and seek IRB guidance and approval.

• Step 5 - Regulatory monitoring of the ARMP: "This is done by the department research committee, which could be research supervisors or whoever has been designated to take that role," Thompson says. "Each department has its own designated person or persons."

The Office of Protocol Research recommends that departments have a team of people conduct the regulatory monitoring, says Wanda Quezada, CIP, research regulations manager of the Office of Protocol Research.

The team monitors the review schedule, meets to see if the plan is working well and ensures that it aligns with institutional and departmental policies, Thompson says.

The meetings should be weekly or bi-monthly and used to discuss protocol status and unanticipated problems that have occurred.

In step 5, the ARMP's action items are to set review schedules, use audit tools developed by regulatory groups or the institution, and identify how safety information is communicated to the IRB, institution, sponsors, and others.

• Step 6 - Outcome expectations: "The research committee should report to the department chair all findings and outcomes," Thompson says.

The committee should see that the site adheres to the plan and perform quality improvement assessments and make adjustments to the plan, periodically, she adds.

"As changes are needed or things start to come up that should be added to the plan, it can be revised," Thompson says. "You need to look at what's going on as a whole with regard to compliance issues."

The ARMP can be used to define the department's best practices, as well.

The six steps could be seen as a circular flow chart. After assessing outcomes, it's time to return to step 1 and review the department's profile and resources as they relate to the research being conducted.

Reference

  1. Quezada W, Olson M, Thompson E, et al. An essential regulatory compliance tool for the development of an administrative monitoring plan. Poster presented at the 2009 PRIM&R Advancing Ethical Research Conference. Nov. 14-16, 2009. Nashville, TN.