It is important to realize what is really important in both site and staff selection.
The routine monitoring visit started out like any other. My focus was to review the extensive regulatory binders at a large, multi-specialty clinic/research practice participating in a pivotal phase III oncology study my company was sponsoring. The Study Coordinator (SC), though overwhelmed, still managed to work effectively to meet every deadline. I had monitored this study at the site for several years and, consequently, had developed a strong rapport with the SC. She trusted my advice and I respected her work ethic, which resulted in a productive, data-driven flow during visits.
The complex, long-term study had produced numerous protocol amendments, Informed Consent forms and a plethora of IND safety reports/correspondence. The SC and I were developing a more categorically and chronologically organized filing system to house the monstrous content of the regulatory binders. We needed to more effectively track essential document lifecycle from inception to expiration and create more efficient access to essential documents.
Though the binders were cluttered, the essential documents had been submitted and maintained correctly; my review had not resulted in any significant findings.
Successful site management requires a committed and transparent dialogue between the CRA and site staff. The dialogue may not always be pleasant, but with a constructed dynamic that focuses on the best interests of all participating parties, the communication almost is always productive. My diligence in practicing this philosophy had helped me maintain successful relationships with the sites I managed. The SC balanced a daunting workload and met diverse regulatory and data deadlines of the sponsors with whom she worked. Her effort warranted my praise for a job well done. A kind word went far toward a solid working relationship.
“Thank you for always working hard. I really appreciate it. It helps me do a better job for your site.”
Her surprising response was cautious, tinged with frustration over an unfortunate encounter with an inexperienced CRA. During a recent pre-study assessment visit, the SC had responded honestly to a routine question regarding staff experience. When asked about her experience/education, the SC said she had worked as an SC for 16 years (impressive for that position), but she did not have a college degree. This was noted, and the CRA continued the site assessment without incident.
Several weeks later, the PI and staff received a follow-up letter notifying them of study selection. However, to the SC’s surprise and embarrassment, the CRA had noted her lack of a college degree as a negative finding.
I was extremely surprised and disappointed to hear this. Education and experience are always considered when assessing staff for a study, but one does not supersede the other. They are equally important. Though pharma and CROs historically require their employees have a four-year degree, this requirement does not and should not extend to site staff. Of paramount importance is appropriate experience. The more trained and experienced the site staff, the stronger the likelihood of clean data, high enrollment and successful study conduct. GCP guidelines and 21CFR regulations demand clinical investigators have the necessary education, experience and training to fulfill their roles and appropriately delegate responsibilities to qualified staff. The guidelines do not dictate the years of education required for support staff; that assessment is at the discretion of the investigator.
One treads a slippery slope when putting such stringent criteria on site staff selection, negatively citing an investigator because a staff member he/she chose lacks a degree. When the sponsor selects a PI, it entrusts him or her to commit to trial conduct and oversee the site staff. Citing a lack of formal education does not reflect due diligence or monitoring proficiency. Rather, it could be perceived as questioning the PI’s judgment in selecting his/her staff. It can undermine pivotal relationship development.
Successful pharma/biotech/CROs value strong, experienced sites and strive to foster these important relationships. Site staff are the first line in the critical data collection and reporting process. We absolutely require reciprocity in communication and trust at the site management level. We should avoid undermining or devaluing the site staff on whom we rely.
E lizabeth Blair Weeks-Rowe, LVN, CCRA, has spent nearly 14 years in a variety of clinical research roles including CRA, CRA trainer, CRA manager and business development director. She has written and edited newsletters for several CROs, created training curriculum for CRA/clinical research educational and training programs and is a contributing writer to several research publications. She currently works in relationship development/study startup in the CRO industry.
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