Guideline for Training Research Personnel

Historically, individuals overseeing human subject research (PIs or otherwise) have relied largely on ‘on-the-job’ training, in addition to the basic training requirements described above, as a mechanism for training new research personnel. ‘On-the-job’ training, however, is typically only as effective as the experiences a trainee encounters and the experience of the mentor providing job oversight, which may or may not be accurate, complete, and/or comprehensive. Moreover, as the nature of research continues to intensify in complexity, the shortcomings related to approaching training in this manner have become increasingly problematic.

In light of these challenges and the continued need to produce a highly skilled and qualified workforce, several professional organizations have published articles and white papers supporting a competency-based training approach among clinical research professionals. Briefly, competency-based training is learner-centric; which focuses on what trainees need to ‘know’ and ‘do’ to meet their job responsibilities. Additional characteristics of competency-based training include structuring training in a manner that allows trainees to move, at their own pace, through a sequential, hierarchy of training modules and assessing progress in settings that mimic real-world scenarios ^{[1, 2]}

In 2013, the Joint Task Force (JTF) for Clinical Trial Competency was convened to align and harmonize existing clinical research competency frameworks (e.g., from the Consortium of Academic Programs in Clinical Research, Academy of Physicians in Clinical Research, Association for Clinical Research Professionals, and Regulatory Affairs Professionals Society). One of the aims of the resulting harmonized competency framework is to support training initiatives and workforce development by identifying a comprehensive set of skills necessary for conducting safe, ethical and high-quality clinical research ^[8]. The JTF framework has since been updated and a ‘leveled’ version published to reflect increased competence through career advancement ^[7]. Additional competency statements, building off the JTF framework, have also been published through the Clinical and Translational Science Award (CTSA) Consortium’s Enhancing Clinical Research Professionals’ Training and Qualification project, including suggested edits to accommodate social-behavioral research ^[1].

From a training and onboarding standpoint, these publications can be utilized to identify competencies required for a given role. Once identified and prioritized, training and onboarding plans can be developed and structured in a way that supports staff in achieving the desired competencies. Training resources that are readily available to aid research personnel in meeting these competencies are identified below.

key point: Have a plan

Investigators have protocols in place to carry out their research systematically; training and onboarding should be approached in the same manner. Plans should be specific to the individual, based on their responsibilities and prior experience. Evidence further supports the utilization of a competency-based training curriculum for workforce development. Research-related competency standards can assist investigators in identifying what training may need to take place and how training should be structured.

As mentioned above, training should focus on both ‘knowing’ and ‘doing’ ^{[1, 3]}.  Staff training is often centered on knowledge development, without a useful balance of applying that knowledge in meaningful settings to foster skill development.

A common methodology for skill development is the four-step process of LEARN, SEE, PRACTICE and DO, whereby a trainee learns about a specific skill or procedure by acquiring knowledge, sees the skill/procedure demonstrated, practices the skill/procedure with correction and reinforcement, and then performs the skill/procedure. More recently proposed skill development frameworks expand this process to include the additional steps of PROVE and MAINTAIN.

In this manner, once a trainee has practiced a skill, they undergo objective assessment to ensure a certain skill level has been obtained prior to performing the skill/procedure independently. The trainee is then further expected to maintain skill level through regular practice ^{[4, 6]}. As such, to the extent possible, building in opportunities for trainees to observe, practice and prove a trainee’s skill achievement, prior to independent performance of a given skill, will be of mutual benefit to both the trainee and supervisor/PI.

Key point: Knowing ≠ doing

Trainees are not typically able to successfully apply new information automatically. Skill development requires multiple opportunities for observation, practice and feedback.

Trainees are not capable of retaining all the information they are exposed to in one sitting. Deliberate re-exposure of information and continued opportunities for skill observation and practice through continued monitoring and training activities are necessary, at appropriately spaced intervals, in order to enhance retrieval of the information ^{[5, 6]}. Similarly, as research and the regulatory climate continue to evolve, it is essential for workforce members to remain up-to-date on developments and best practices.

To accommodate continued training, support and performance monitoring:

• Set specific, measurable onboarding and training goals based on the needs/role of the individual, e.g., set goals for each quarter of the trainee’s first year based on prioritized competency statements.
• Meet regularly with trainees to review progress, discuss milestones and provide feedback. As goals are reached, create new goals or consider how to advance original goals, accordingly.
• Incorporate quality checks and/or formal quality assurance processes to assess trainee performance and proactively. Performance errors that are not identified cannot be corrected, nor prevented. Incorporating a Quality Management Plan (QMP) into an onboarding and training plan (or by protocol), using the Plan-Do-Check-Act approach, will ensure the success of your team, as well as the research.
• Use ‘teachable moments’ to enforce requirements and/or best practices. Errors and ‘outlier’ or ‘one-off’ incidents (that aren’t necessarily performance-related) are going to happen over the course of research. Utilize such incidents to encourage trainees to reference/re-train on applicable regulations, policies and/or good practices.
• Monitor shifts in responsibilities or workload as research protocols progress through their lifecycle (i.e., start-up, implementation and closeout). Shifts in responsibility often require re-evaluation of staff training needs and time commitments. Time commitments, particularly when staff are engaged in multiple studies, with multiple PIs, can easily be overlooked and underestimated, especially as existing research protocols are completed and new ones are initiated. Overburdened staff are less likely to be able to dedicate an appropriate amount of time to continued training and are at risk for burnout and failures in performance, which can ultimately put the research, and the subjects enrolled, at risk.
• Set forth expectations for trainees to participate in continuing education opportunities and safeguard time for them to do so, e.g., set a goal for staff to participate in at least 8 hours of continuing education each performance cycle. Local continuing education opportunities, that are available at no-cost, are regularly offered through OHSP, the Clinical & Translational Science Institute, the Study Coordinators Organization for Research & Education and several external organizations (e.g., Advarra and WIRB-Copernicus Group [WCG]).
• Financially support trainee membership in research-related organizations (e.g., Association for Clinical Research Professionals [ACRP]; Society for Clinical Research Associates [SOCRA]) and attendance at local or national research-related conferences.

Key point: ‘good’ training takes time

Trainees need time to digest the information they are provided and repeated exposure to information to successfully retain and apply information. Phased (or spaced out) training, provided at an appropriate pace, will further aid retention and application.