Life lessons of etiquette and manners resonate strongly in today’s stressful business environment.
Punctuality, reliability, confirmation, responsiveness and follow-through influence action, guide decisions and serve as the foundation for relationship development.
Relationship development is key to my role in study startup. All elements of pre-study assessment visit conduct are geared toward investigational site ease and efficiency. How I conduct myself will impact current and future circumstance. I arrive early to investigative site meetings and always call even if I am going to be a few minutes late. All appointments are confirmed by email and followed with a calendar request.
A recent experience made me think twice about considering a site before I had even completed the assessment. An investigational site director confirmed a pre-study assessment meeting, only to no-show the day of the meeting, without any explanation. My first instinct was to leave; my time was not respected, and this behavior hardly conveyed interest. Instead, I decided to contact the director for an explanation. I felt compelled to consider all facts before making a judgment.
Our cardiovascular group was selecting West Coast sites for a phase III hypertension study. The investigator/site had enrolled well on the sponsor’s previous study. I scheduled the pre-study assessment visit with the site director personally and followed up with a calendar request, which was promptly accepted. A week prior to the meeting, I sent the confirmation letter. Imagine my disbelief when, after a two-hour drive to the site, the front desk receptionist informed me that the director was out of the office. I excused myself to call the site director.
She answered her cell phone on the first ring. I calmly identified myself, and reminded her of our meeting. With an intake of breath, her candor surprised me. “I completely forgot about our meeting, and I am so sorry.” She explained that there had been an emergency at another site location, which had completely thrown her off schedule. She still wanted to conduct the assessment visit, and asked if she could call me back in 10 minutes. She needed to track down the investigator and make alternative plans. “I promise I will make this work” were her parting words. I had my doubts, but agreed to her request and waited for her call.
Exactly 10 minutes later, the director called me back. She had located the investigator, who was going to come by the site on his lunch break to speak to me. She proposed that we conduct the site information and question portion of the assessment via teleconference. Meanwhile, she could arrange for another study coordinator (SC) to come to the site for the facilities tour, and to answer any remaining questions I had about the staff and organization.
I considered the situation. Though unconventional, the plan met all elements required for site assessment—investigator/site study discussion, site information and experience and confirmation of facilities and equipment.
The director acknowledged and apologized for her error. Instead of making excuses and trying to reschedule the visit, she had arranged a plan that saved resources and accommodated needs. I was impressed with her creative thinking and consideration. We proceeded with the pre-study assessment meeting.
The director and I discussed site experience, recruitment, staffing and research policy via conference call in the site conference room. The SC arrived from the other site at the end of the call and I was able to confirm all study equipment in a reasonable timeframe. The investigator rushed over from the hospital on his lunch break. As he had already reviewed the protocol, we were able to discuss study design, eligibility and recruitment in an efficient manner. He provided relevant feedback and positive enrollment projections.
The director called me at the end of the visit. She asked me to consider the site based on visit content and not visit prelude. Her sincerity touched me.
On the drive home from the site, I thought about the events of the day. The director had gone above and beyond in her reparation efforts. The investigator had changed his schedule to accommodate my time requirements. The study coordinator had interrupted her day to help me stay on track with my schedule. All key players had cooperated to ensure visit success. I could not have asked for a better show of solidarity. I could not have asked for a better solution. I recommended the site based not only on visit content, but on their collective response to ensure the visit was a success.
Elizabeth Blair Weeks-Rowe, LVN, CCRA, has spent nearly 14 years in a variety of clinical research roles. Currently she works in relationship development/study startup in the CRO industry. Email email@example.com.
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