Karen Arts

Clinical research professionals, such as coordinators and administrators, play a key role in the success of clinical research projects. In order to meet global standards, clinical research professionals conducting clinical research involving human subjects are required to take training in guidelines for good clinical practice (GCP), which describes the responsibilities and expectations of all participants in the conduct of clinical trials, including investigators, monitors, sponsors, research ethics boards, and clinical research staff.

  Another standard which is being accepted increasingly by organizations conducting clinical research involving human subjects is training in the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS).

Clinical research training practices vary across the globe and likely rely on available resources to provide such training. Most of the clinical research training offered in GCP and the TCPS is offered through classroom or online tutorials. These formats provide the required subject matter, a quiz, and a certificate of completion as formal recognition that the training has been completed. However, this format for training often lacks the practical aspects of transferring this newly acquired information into practice.   

Frequently, training of new clinical research professionals is left to the principal investigator, who is ultimately responsible for ensuring compliance of the project with the applicable regulations. In many situations, clinical research training may be delegated to other members of the research team, or left up to the individual themselves. Inconsistent work practices, questionable data quality, and protocol execution issues may be encountered if learning the day-to-day operations of clinical research is done informally and/or on the job.

Peer-to-peer mentoring can be described as a form of mentorship that takes place between a person who has an expertise in a particular skill and a person who wants to learn that skill, where both the mentor and mentee may be at the same level in an organization.

  Peer mentoring can offer a valuable source of support and information to less seasoned staff that work within similar work environments, and can offer an organization or research team a low-cost method of training new research staff.

In response to the need for clinical research mentoring within an environment of limited resources, the Network of Networks (N2)

  developed a peer-to-peer mentoring program to provide mentoring opportunities to research professionals across Canada. By developing a system where seasoned clinical research mentors are paired with less seasoned mentees, the goal was to offer guidance to clinical research staff who have little formal training, as well as support staff in the acquisition of new practice skills.  

The N2 Mentoring Program is coordinated by a committee of voluntary research professionals, which is responsible for communication about the program to N2 members, reviewing applications, pairing mentors with mentees, and evaluation of the program. Mentors participate on a voluntary basis and the program is available to all N2 members at no cost.  

N2 is a not-for-profit collaboration of healthcare organizations and other stakeholders, in Canada, that conduct clinical research involving human subjects. N2 is a national initiative that aims to enhance Canada's research capability and capacity, whose membership includes over 200 clinical research sites across Canada.   

Development of the peer-to-peer mentoring program 

The overall goal of the N2 Mentoring Program is to pair mentors, who have expertise in conducting clinical research, with mentees, who are in need of developing new skills in conducting clinical research. As part of the planning process, the N2 community was consulted through surveys, for suggestions on topics such as mentor criteria, determining the length of the mentor and mentee relationship, and mentoring formats. By having the mentoring program under the auspices of the N2, all mentors had access to the most up-to-date research tools, standard operating procedures, information about best practices in clinical research, and access to more formal training in the regulatory requirements of conducting clinical research. The goals of the mentoring program are:  					

To facilitate a national, institutional mentoring program by pairing volunteer mentors with more junior colleagues for a four month period 

To develop a roster of mentors along with their areas of expertise 

To develop a process by which mentees will be paired with appropriate mentors 

To obtain feedback from both the mentor and mentee about their experience. 

The mentoring formats are decided upon by the mentor and mentee and can be person-to-person, via telephone, e-mentoring, or a combination of all three. 

Both mentor and mentee participants are required to complete an application form before they are considered for pairing. The form asks for demographic and contact information, area of research expertise, therapeutic area, and number of years of experience in research. Mentor applicants are asked to check a list of areas of expertise in which they can provide mentoring. Mentors are chosen based on the following criteria:  					

Research professionals who have at least five years experience in clinical research 

An expertise in a particular area of clinical research 

Interested and available to provide mentoring to less seasoned clinical research staff 

Mentee applicants are asked to check a list of areas in which they would like to receive mentoring. All participants are asked to provide consent to have their name and contact information shared once a potential match is found. 

The mentoring committee reviews all applications within five days and a response to applicants indicating their application has been received is sent. The information in the application forms is inputted into an Excel database, which is stored on a secure network. This information is the source for the mentor and mentee pairing and makes up the mentor roster for future pairings.   

When an application form is received from a mentee, a member of the committee reviews the areas in which they want to receive mentoring. The mentor roster is then reviewed for a mentor who has an expertise in the area of expertise being requested. The mentor is then contacted to determine their availability for mentoring. If a suitable pairing can be made, the mentor and mentee are contacted by a member of the mentoring committee and their contact information is exchanged.  

The mentoring committee recommended a period of three-to-four months for the mentoring relationship, with the belief that having a clear endpoint would make the mentor/mentee pair more productive. Mentors and mentees are invited to contact the committee at any point in the relationship to request assistance or another match as needed. At the three-month mark the committee makes a point of checking in with the pair to see how the mentoring relationship is progressing. The committee contacts both the mentor and mentee to obtain feedback through an anonymous online survey once it is determined that the pair has reached their goal.   

In August 2011, information about the N2 mentoring program was sent electronically to all research organizations that are members of N2. Each organization has a N2 member representative responsible for distributing research information in accordance with its own organizational process or guidelines. Interested individuals were encouraged to complete the mentor and/or mentee application forms and send them to the N2 mentoring committee. 

Six months after the initial communication, a newsletter was sent through the same process to all N2 members with an update regarding the mentoring program. The newsletter provided a description of the mentoring program and progress to date. Interested individuals were encouraged to forward completed application forms to the mentoring committee. 

On an annual basis, the N2 community provides input on the need to continue with the N2 mentoring program. In 2012, the N2 community indicated that the need for a clinical research mentoring program continued to exist.  

Through an anonymous survey, participants of the N2 mentoring program also provide input on their experiences and are offered the opportunity to provide input on how the N2 mentoring program can be improved. In the paragraphs to follow, we offer results of our N2 mentoring program evaluation. 

Currently the mentoring program has 14 research professionals who have volunteered to be mentors. Mentor applications were received from Alberta, British Columbia, and Ontario.   All mentors have at least five years of experience (range five to 25 years). The mentors come from a variety of clinical areas, such as: acquired brain injury, cardiovascular, hematology, mental health, oncology, pediatrics, and eye research. Many mentors have expertise in monitoring, auditing, training, clinical trial coordination, budget, and contract negotiation. The mentors used a checklist on the application form to indicate the areas in which they were comfortable in providing mentoring. The most common areas of expertise were consenting research subjects, clinical trial applications, education and career development, and SOP development. 

Currently the mentoring program has 14 research professionals who have requested mentoring in particular areas of clinical research. Mentee applications were received from British Columbia, Ontario, and Saskatchewan. Mentees have varying years of experience ranging from less than one year to 16 years. The mentees come from a variety of clinical backgrounds such as brain injury, cardiovascular, eye research, kidney disease, and orthopedics. Many mentees have roles in clinical research coordination, or research administration and management. The mentees used a checklist on the application form in order to identify areas in which they wanted mentoring. The most common areas were grant preparation and regulatory requirements. 

All individuals who sent applications for the mentoring program received an acknowledgement e-mail within 10 days of receiving their application. If a pairing was suitable, contact information was provided to both mentor and mentee. It was up to the mentor and mentee to make the connection and establish the goals of their relationship, the most suitable method of communication, and to determine the length of the mentor/mentee relationship. Whereas no timelines were set for the relationship, a committee member contacted the pair after three months to enquire about progress. 

As of August 2012, the mentoring program successfully paired nine mentors with mentees. In seven out of nine cases, the mentors and mentees worked in different cities. There were five mentees that had not yet been paired. One reason was that a mentor was not available to provide mentoring in the expertise being requested. In these cases the mentees were notified of the situation, and told they would be contacted once a mentor became available.   

The goals of most mentor/mentee pairings had been achieved by three months. A survey link was sent via e-mail to the 18 participants, both mentors and mentees that had completed the mentoring program. Seven participants responded to the survey, which gave a response rate of 39%. Four of the respondents were mentees and three were mentors. The mentoring committee reviewed the feedback provided by the respondents. 

The survey asked participants the following four questions: 					

Please share the best part of your experience. 

Overall how valuable did you find your mentoring experience? 

What suggestions do you have about how we could improve the program?

Do you agree to us sharing your name and best part of your experience in the N2 newsletter? 

To the final question, all respondents agreed to having the best part of their experience shared in the N2 newsletter. However some did not want to have their name identified.   Some common responses that emerged from the mentees were:  					

An appreciation of the time their mentor spent with them

The mentoring program was easy to accommodate into their busy schedule

Mentors were able to provide support through shared experience

Mentors provided valuable tools and information which helped in developing skills 

Common responses from the mentors included: 

Articles

Clinical research organizations should look to peer-to-peer mentoring for professional development.

Karen Arts

Articles

Developing a Successful Peer-to-Peer Mentoring Program