After my first SIV, I was very concerned that my career in clinical research was on the line. How could I have failed so miserably?
The SIV was poorly completed, from preparation through execution, and was an abject embarrassment. The only positive aspect was that it provided an invaluable perspective on the importance of adequate protocol training, the delicacy of sponsor relationships, and how to recover/perform amid strife. The remnants of that dismal failure amassed to form the solid framework for future SIVs that was comprehensive, effective, and engaging.
I conducted my first SIV approximately three months after I became a CRA. Although I had been cleared for independent SIV conduct, the study design was more complicated than my inexperience warranted, and I was ill prepared. The study treatment was a combination device/drug product. The SIV training (if you could call it that) was piecemeal and unclear. The study manager sent a complicated email with an overview of study background and timelines; the protocol, investigators brochure and supporting study documents were attached in a zip file. The research organization for which I worked was small and the study manager overwhelmed. Though she advised me to contact her with any questions, I felt left to my own devices and more than lost with the poor direction provided. There were no protocol powerpoint slides to artfully lead a study training, sectioned according to assorted topics of importance as per normal process (timelines, endpoints, inclusion/exclusion, study drug, study visits, schedule of activities, systems/vendors, etc.). There were no spreadsheets maintained that tracked site supplies, equipment, or site systems access. The sponsor manager was to accompany me to the SIV for additional support but was more adversarial than advisory. The entire experience was humiliating and did not leave the site with a positive impression of sponsor/CRA collaboration. The most disappointing part was that all the deficiencies could have been prevented with the right guidance.
SIV preparation is complex, intense and time consuming. CRAs spend hours reviewing the protocol slide decks and rehearsing the content for familiarization, with the goal of engaging the audience in a productive study discussion instead of boring the audience with a bullet point recitation of already dry material. It is the study teaching visit and retention is critical. Lacking such guidance, my preparation process for the SIV was not thorough enough. I reviewed the protocol, tabulated key sections, and highlighted critical points to review with the site. However, I did not familiarize myself with the information enough to conduct an effective discussion. I genuinely thought that reading aloud from key sections of the protocol during the SIV would be sufficient. I did not confirm site receipt of study drug and study lab kits/supplies before the visit as I naively presumed the study team had arranged this. In retrospect, I should have consulted my CRA line manager regarding the SIV process. She would have sought additional training from the study manager to supplement my lack of experience of the formal requirements. The burden of responsibility for the ineffective visit was shared equally by me and the study manager.
The sponsor, site and I had confirmed the SIV date/time several times over email, with a calendar reminder sent so all parties were clear (9:00 a.m.). I awoke the morning of the SIV with a feeling of dread that went way beyond nerves. I did not understand the source of this angst, for I thought I had completed everything necessary to proceed. I had mapped out the site location to ensure I would not get lost. I had emailed the sponsor again to confirm that we were meeting in the lobby at 8:45. I arrived at the site thirty minutes ahead of the visit and even sat in the lobby for ten minutes before checking in with the receptionist. However, despite all the confirmations, the SIV had started without me. I was escorted back to the conference room to find the sponsor, Principal Investigator (PI) and study coordinator (SC) discussing the Investigator’s Meeting and various study timelines. The sponsor was taking notes and confirming information, which was my job the last time I checked. I was very confused and flustered by this because I had not been informed of any change. However, I decided it was not important enough to mention and to proceed normally. Miscommunications occur and this was not particularly important.
I introduced myself to the PI and SC, greeted the sponsor and took a seat around the imposing conference table. I asked the attendees to open the protocol to the introductory paragraph and began my nervous review of the accompanying sections I had flagged. Unfortunately, I made the rookie mistake of not “checking” the room to see how my audience was responding, for I would have made it more interesting based upon the PIs look of boredom and the sponsor’s frown. After several minutes of review, the sponsor representative interrupted me and declared impatiently that I did not need to read every line from the protocol, the PI and the SC knew the information already.
The sponsor’s unexpected interruption was shocking. I glanced up and apologized to everyone. The negative thought that was building momentum, and rapidly gaining ground, spoke volumes to my dismay. “This is bad. This is bad. This is bad.”
My hands were unsteady as I fumbled with the protocol pages and flipped to the inclusion/exclusion section. I briefly looked around the room; the SC met my eyes and smiled in encouragement. I took a deep breath and started to review the eligibility criteria in detail. I spoke too rapidly and tripped up on some complex pronunciations. After several minutes, the sponsor made another stern interruption. He directed me to “move it along” and only review the critical criteria. He shook his head at the investigator, not bothering to hide his frustration. I felt a flush of embarrassment creeping up my neck and I willed it back. I then cleared my throat and asked the attendees to please move to the study drug section of the protocol. My plan was to review this information in detail as it was critical; storage, preparation, administration, accountability, etc. About two paragraphs into my review of the study treatment section, the sponsor interrupted me for the third and final time. He announced that would review the study drug information section and promptly took over the discussion, leaving me speechless. His displeasure was palpable, and I dreaded the aftermath of this disastrous meeting.
After the sponsor finished the study drug discussion, I was able to complete a review of the study procedures, schedule of assessments, visit schedule and timing, vendors, and all remaining SIV items. We completed the facilities tour, and my review of the investigator site file and inventory of study drugs concluded the visit. The sponsor and I thanked the PI and SC for their time and feedback. We let them know how happy we were to have them participating in the study and confirmed their screening efforts could commence immediately. I was mentally exhausted and immensely stressed and going on autopilot as I filed everything in my monitoring bag. I did not notice the sponsor leaving, only that he did not even bother to say goodbye. I walked slowly to the exit with my head bowed. When I arrived at my rental car, I started to cry. I was so mad at myself and just devastated over all that had happened. I knew I had done terribly to elicit such a negative response from the sponsor. It mattered not that his behavior was highly inappropriate; he was the customer and the impression I made reflected badly upon his company and the entire study team. I wondered if they would fire me.
I called my line manager on the way to the airport and tearfully recounted the events of the day. She was sympathetic and assured me that she would follow up. I arrived home late that evening, and tossed and turned for most of that night, unable to sleep. The events of the visit kept replaying in my mind. Where had I gone wrong? What could I have done better? What an idiot I was to think that I could conduct such a complicated visit.
Early that morning I logged onto my computer and checked my email. My line manager had scheduled a meeting for later that day. She was honest about the sponsor’s feedback; they were displeased with my performance and were going to follow up with the study manager about the training material. I was, however, neither fired nor kicked off the study. My manager apologized for the sponsor’s rude behavior during the visit and reassured me that this was the exception and not the rule with other sponsors. She then encouraged me not to dwell on the experience, but instead use it as a learning opportunity for the next SIV. She then planned another meeting where we would discuss the SIV process in detail and perform a mock visit. She apologized that I had not been provided with better training and support. Her constructive criticism was that I should have asked for help with such an important visit and in the future, I should not rely on myself if things were that unclear. She was right and I agreed.
The next SIV I completed (a month and several rehearsals later) was the opposite of that first debacle. I was provided comprehensive study training, including detailed protocol slides and accompanying presentation materials that I provided to the investigational site ahead of the visit. I rehearsed the materials to the point that I could have reviewed the information in my sleep. I made sure I tracked the status of systems access, supplies and investigational product for the site prior to the visit and provided them status updates. I crafted an SIV checklist to ensure visit flow and confirmation of site information. I finished that second SIV feeling confident in my abilities, and that my delivery was effective, accurate and engaging.
Ten years and many therapeutic areas later, I was working on a phase three oncology study and was asked by the study manager to conduct a prominent level SIV at a well-known academic health center. The PI was a key opinion leader and would have an array of institutional investigators present. It was a pivotal visit and I had been chosen, ironically enough, to complete the SIV due to my strong standing with the project team. Though extremely nervous, I was looking forward to the visit as it was a wonderful career development opportunity. I spent hours preparing for the visit: reading, rehearsing, familiarizing. The day of the visit, I arrived early to the site and the SC helped connect my laptop to the large wall monitor in the imposing conference room where the meeting was to occur. Ten minutes before the SIV the attendees started arriving: physicians, nurses, and finally, the PI. There were a total of twenty individuals in attendance; experienced oncology staff who were already familiar with the study design/requirements. Though inwardly nervous, I spoke confidently to the material, asked insightful questions, and effectively engaged the room for over two hours. It was by far my best performance.
After the visit, I sat in my car and thought about what had brought me to this place. That first SIV left me humiliated, dejected; it was the opposite of the sheer joy I felt over my performance today. I had conducted that first SIV without proper training and support, but the experience dramatically changed the trajectory of future performance and for that I felt grateful. Clinical research is daunting for the uninformed, and a program like Clinical Research Fastrack would have provided foundational training that would have better directed me in my knowledge and preparation process, as SIV conduct is included in their training.
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