Assuring data quality in investigator-initiated trials in dutch hospitals: Balancing between mentoring and monitoring

Figures & data

Table 1. Contrasting monitor and mentor (adopted from Connor and Pokora 2012, 38).

Monitor (expert)	Mentor
Focus on compliance (Weijer et al. 1995; Korenman 2006)	Focus on feedback (Rabatin et al. 2004)
Emphasis on knowledge	Emphasis on mutual learning process (Kram and Isabella 1985; Angelique, Kyle, and Taylor 2002)
Expert insight is key	Helping skills are key
Puzzle-solver	Facilitator/enabler
Gathers/analyzes information	Enables information gathering
Facts and logic	Facts, logic, and feelings
Diagnoses the problem	Explores the problem
Objective definition of problem	Subjective definition of problem
Expert knowledge important	Mentee insight important

Table 2. Themes and their related codes.

Themes	Codes
Interviews staff members
Background staff members	-
Reasons to set up and implement a quality management system for research	Inspection visits, guidelines (sub)sector associations, assurance of data validity, mergers
Design of quality management system (and monitoring/mentoring)	Decision-making by BoD on advice of staff members
Roles, responsibilities, and escalation procedure between BoD and staff members	Defined or under development
Risk classification by guidelines (sub)sectors or MREC	Consequences for monitoring/mentoring clarified or under development
Qualifications of monitor vs. mentor	Expert (pharmaceutical industry experiences) vs. colleague (peers)
Training/knowledge exchange of monitors/mentors	By experts and peers, tailor-made, scientific meeting
Link with MREC for an overview of approved studies	Yes/no
Procedures for monitoring/mentoring	Frequency, different approach depending on risk classification, SOPs, formats, and templates or under development
Searching for pragmatic solutions	Starting from scratch, efficient organization mentoring visits (e.g., planning peer-to-peer visits or planning a few different visits each year)
Dealing with the gray zone	Translate regulation into research practice
Offering a data- and/or study-management system	Developed or under development
Providing support in mentoring system	Matching researchers, facilitating start and debriefing of a meeting, supporting decision-making, preparing or reviewing the report
Relationship management	Actively manage its relationships with the BoD, researchers, colleague staff members of other hospitals via (sub)sector associations
Key success factors	Support of the BoD, resources from the hospital, knowing your researchers, providing support to researchers (being in contact, answering questions), qualified monitors/mentors
Monitoring vs. mentoring (observations/interviews)
Guides the process of the meeting	Self-supporting vs. support from staff member
Clarifies goals of meeting	Self-supporting vs. support from staff member
Provides information and resources (SOPs, templates)	Self-supporting vs. support from staff member
Provides feedback	Open, directly, constructive, detailed, positive, critical
Support for their tasks as monitor/mentor	Self-supporting vs. support from staff member
Backbone	Knowing the essence of doing research by heart or using a checklist
Creating/facilitating a learning environment	For knowledge transfer (one-way) vs. mutual learning (two-way)
Factors that affect dialogue/collaboration/ interaction	Listening actively to each other, open-minded toward (new) ideas, asking clarifying and in-depth questions, power vs. equity, providing tips, explaining important concepts
Focus/relationship	Following regulation and problem-solving vs. a two-way flow of assistance and support
Reporting	Self-supporting vs. support from the staff member

Table 3. Characteristics of hospitals, a summary of key elements.

	UMC I [2017]	UMC II [2016]	UMC III [2016]	Teaching hospital I [2015–2016]	Teaching hospital II [2018]	Teaching hospital III [2016]	Teaching hospital IV [2018]	Teaching hospital V [2018]
Chosen system	Mentoring, recently started	Monitoring and mentoring	Monitoring	Mentoring, recently started	Monitoring; (re) thinking/ (re)considering the system	Orienting toward a mentoring system	Mentoring	Mentoring
Detailed descrip-tion	Two mentors work together to mentor one research study during a central organized mentoring day (peers)	Nine divisions have provided money for central monitoring with which two centrally appointed external monitors are temporarily appointed and paid. In the other three divisions, monitoring is done by self-trained personnel. Research with minimal risk is monitored by a research nurse or BROK-qualified researcher (mentoring)	Monitors, most with a pharma-ceutical back-ground, are a part of a staff department	Peer-to-peer mentoring with two researchers assessing each other’s study	Monito-ring; (re) thinking/ (re)considering the system	Mentoring (planned). At this moment, no policy, programs, or structures available; building on the experiences of teaching hospital I	Mentoring is done by a research nurse	Mentoring, building on the experien-ces of teaching hospital I
Recruit-ment, managing, and support of monitors/ mentors	Staff department; recruitment of mentor(s) by each department (obligatory)	Staff department; recruitment of mentor(s) by each department in three divisions (obligatory)	Staff department; working with internal monitors	Staff department; recruitment of mentor(s) by each department (obligatory)	Staff depart-ment	Staff department	Staff depart-ment	Staff department

Table 4. Characteristics of mentoring and monitoring in practice.

	Monitoring	Mentoring
Profession	Being a monitor is their profession; a monitor works on 60–80 studies on average at a time.	Being a mentor is a side activity for members of a research team; a mentor periodically takes on one study.
Hierarchy	A monitor is an expert, often with experience in the pharmaceutical industry, who has a professional understanding of regulations.	A mentor is a colleague, who has experience with and knowledge of daily research practices.
Structure	Each research study is visited several times: initiation, monitoring, and close-out visit. Result-oriented.	Each research study is visited at least once by a peer and in some cases a staff member does the follow-up. Research-process oriented.
Focus	Explication, compliance with (inter)national standards, and immediate correction. Focus on procedural information, the practical application of knowledge, and the policy principles of the organization.	Training, problem-solving, support, and encouragement to comply with (inter)national standards. The focus is on the practical implications of doing research and increasing work-related fulfillment.
Support	Monitor is self-supporting. Support from colleagues (monitors) and/or staff members upon request.	Support from staff members during (peer) mentoring is crucial to decision-making, reflection, and reporting.

Table 5. Learning perspective in monitoring and mentoring.

Monitoring	Mentoring
One-way learning: from monitor to researcher	Two-way learning: mentor and researcher both learn (Clutterbuck 2014)
“Supervision” perspective	Collaboration perspective
Hierarchical relationship. Apply “master-pupil” model as a powerful teaching method to transfer knowledge	Nonhierarchical relationship (Morton-Cooper and Palmer 2000). Focus on equality can be a simple and effective to enhance learning efficiency

Table

BoD	hospital board of directors
CCMO	Central Committee on Research Involving Human Subjects
GCP	Good Clinical Practice guideline
ICH	International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use
IGJ	Dutch Health and Youth Care Inspectorate
IITs	Investigator-initiated trials
MREC	Medical Research Ethics Committee
NFU	Netherlands Federation of University Medical Centers
NVWA	Netherlands Food and Consumer Product Safety Authority
NWO	Dutch Research Council
QMS	quality management system
SOP	standard operating procedure
STZ	Dutch association of non-university (tertiary) teaching hospitals
UMC	university medical center
WMO	Medical Research Involving Human Subjects Act

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