A research institution’s centralized research training program began as a way to help new investigators and research teams learn more about the IRB process and human research protection. But the program, called Navigating Clinical Research, has expanded into a comprehensive training course that uses a variety of adult learning strategies.
“One of the improvements we’ve made to the course is to explain the whole IRB process, as opposed to assuming our audience knows what an IRB is,” says Dorean J. Flores, CIP, IRB manager at North Shore-Long Island Jewish Health System in New Hyde Park, NY.
The training initially was for one day, but was expanded to cover good clinical practice (GCP) in greater detail. Now, attendees must complete the first day of training before enrolling in the second day.
“Day two is heavy on GCP training, geared toward an advanced audience,” Flores says. “So newbies can take day one and that’s fine, but senior researchers can refresh their memories with day one, and on day two they will really test themselves and bring home additional information.”
Here’s how the two-training works:
• Prior to first day of training: “Before the class actually starts, we send out a reminder to people who are registered, suggesting pre-work activities,” says Tina Chuck, MPH, manager of research policy and training at the health system.
“They also must take a CITI program course and a conflict of interest course,” she adds.
The CITI training is required before they are eligible to work on a study, so the IRB asks that the CITI coursework be completed as a prerequisite to taking the Navigating Clinical Research course, says Richard Ramdeo, CIP, IRB manager at the health system.
Attendees also are expected to do some pre-course preparation, including a human subjects research handbook and learning management system.
“Pre-work is determined by the presenter and the topic they speak on,” Flores says.
• First day, morning: A research administrator presents information about clinical research. And the chief operating officer of the Feinstein Institute for Medical Research might provide an overview of the institute’s research in the health system, Chuck says.
“They oversee research for the health system,” she says.
The morning session also includes a presentation from the grants management office. This segment includes a review of definitions related to clinical research funding, resources of information on funding opportunities, pre-award and post-award services, and a discussion of grant and contract proposal application procedures.
“The grants office and vice president for administrative funding goes over databases for researchers to look for funding opportunities and tells them how to work with the grants office to apply for those grants,” Chuck says.
Next up is a presentation by the IRB: “We start off with background information about why IRB committees are required and how they came about in the world,” Ramdeo says.
“Then we discuss the IRB’s principles and regulations,” he adds.
The IRB session also goes over the different types of research studies, and explains how research sites can submit each study.
“We navigate the class through different forms, protocol templates where people can write their protocols and information,” Chuck says.
“We incorporate videos into it to elaborate on the discussions we’re having,” Ramdeo says. “Also, we’ll have training point questions, an interactive polling question that we provide as they see PowerPoint slides.”
Presentations, including the IRB 101 segment, involve discussions with attendees. People are encouraged to talk about their own research, Flores notes.
Lunch follows the IRB 101 segment of the course.
• First day, afternoon: The first afternoon topic is about consenting research participants.
An IRB manager will discuss these issues:
- define research informed consent;
- how to create an informed consent document and how to use templates;
- explain waivers of informed consent;
- discuss who can obtain consent and how to obtain it through both the consent process and documentation;
- provide information on consenting populations with special considerations, including limited English proficiency, minors, and limited capacity.
Research compliance is next. A presenter from the office of research compliance explains the office’s mission, services, and education. Other topics covered include how to navigate the regulatory environment, conflicts of interest, research misconduct, and protecting research subject privacy and security.
The last segment of the day is about research billing. A clinical research service/finance core representative describes research billing policy and procedures and covers Medicare coverage analysis and billing grid development, as well as ensuring compliance and research billing reviews.
“Research billing people explain how to fill out forms for outpatient and inpatient to let billers know that the person is a research subject and shouldn’t be billed to insurance,” Chuck explains.
• Day two, morning: The second day’s curriculum begins with the topic of good clinical practice (GCP). A presenter from the office of research compliance defines GCP, discusses its history, lists the basic principles, and utilizes strategies for compliance with GCP. Medical care of trial subjects and good documentation practices also are covered.
“This part gets into the nitty-gritty of good clinical practice and randomization,” Flores says. “This provides all the information the researcher or coordinator needs to know as they manage the trial and take on more intricate studies like multicenter research.”
The same presenter next will discuss how to conduct quality research, including these items:
- research team readiness,
- protocol and regulatory compliance,
- how to ensure protection of subject safety, welfare, and rights,
- how to ensure device procurement, accountability, safety, and management,
- how to ensure study data accuracy, integrity, and quality through good documentation practices,
- quality assurance, and
- external monitoring, auditing, and inspection.
• Day two, afternoon: After lunch, the session begins with a biostatistics unit presenter discussing the randomization process.
The presenter explains what is a randomized clinical trial and goes over randomization-related data integrity.
Delving into the nuances, there is an explanation of the mechanics of randomization, stratification, open-label, single and double blinded, and “double dummy” randomized clinical trials. Attendees also learn of the step-by-step documentation of the randomization procedure, implementation of randomization procedure, record keeping, and special considerations.
The second day’s session ends early, following an hour-long presentation of the management of investigational drugs in compliance with GCP standards. Presented by the clinical research service’s investigational pharmacy core, this segment goes over these items:
- GCP standards for the management of investigational drugs,
- the investigational pharmacy core,
- the process for managing investigational drugs,
- considerations for study feasibility,
- procurement, accountability, storage, dispensation, preparation, and disposal of investigational drugs, and
- utilization of a health system pharmacy.