By: Barrie Quappé RN, BSN – Consultant/Director:
This article is a continuation of Attending the SOCRA Conference – Great Insights! from last week. The Society of Clinical Research Associates (‘SOCRA’) is a US-based “non-profit, charitable and educational membership organization committed to providing education, certification, and networking opportunities to all persons involved in clinical research activities.” Here are more of my takeaways from the recent SOCRA Conference.
Laura R. Holtz, BS, CCRP covered the topic of “All Other Duties as Assigned: Including Communications in the Project Management Role”. She noted that the Study Coordinator (‘SC’) is the ringmaster, the one who keeps communications working, whether internal or externally. Externally, for example, are the finders: media, advocacy groups, etc. These can also be unknown (like a Facebook post). Internally, the SC must keep information flowing as is appropriate to subjects/families, IRB’s, Referral Networks, Study Monitors, Principal Investigators, Study Staff, other Supervisors and Clinics!
Additionally, she referred to a “Communication Handbook for Clinical Trials” and when you Google search that title, some very interesting items are found. The SC is also responsible for generating support from the public, policy makers, clients, communities – to name just a few.
Holtz provided us with questions to ask as a key: Who (list audiences), What, When, Where, How (what channels) and again from internal to external. She suggested making a Team communications template in Excel, if you don’t have a program for this.
The danger of communication gaps is that they deplete morale, she noted. Checking in with your team and asking if someone feels left out is very important. She further suggested doing SWOT analysis on the topic of ‘Do you feel informed?’ We may have all heard this one before but it is true: “Consistency is key,” Holtz noted. Planning your communications ahead of time will help keep it that way. “Inform, involve, and engage” were her closing remarks. While it is clear that this is no easy task, certainly planning can get you there.
The session titled “Integrated Project Management Approach in Facilitating the Conduct of Ebola Emergency Protocols in West Africa” by Dr. Jiwan Giri, MSPM, MSIS, PMP, Clinical Project Manager II, Leidos Biomedical Research, Inc. was nothing short of riveting. The antithesis to the previous presentation, this situation meant they had no time to plan. In 2014, when the greatest Ebola outbreak in West Africa occurred, 29,000 were impacted and 11,000 died. The impact was felt globally but locally in West Africa there were curfews, quarantines and business interruptions, to name a few.
The World Health Organization and the President of Liberia asked the United States to help. The goal was to conduct trails to find a vaccine. Enrollment was achieved in a record 3-month time and they had a partner that produced outstanding data quality. Once published, they were then able to partner with others in both the US and Liberia. Listening to Dr. Giri, you could hear the urgency and excitement in his voice as if you somehow were being given a window into this incredible project. He kept re-iterating how “they picked the best of the best” in order to move the studies forward as safely and expeditiously as the situation warranted. He did identify some of the challenges they faced:
- No known Clinical Research infrastructure (Liberia)
- In-country logistics
- Local culture/customs/language
- Environment
- Not enough people to help; no-one wanted to volunteer
To capture the wisdom he shared in this summary format is difficult, but he noted that they took the VUCA approach. The acronym stands for Volatility, Uncertainty, Complexity and Ambiguity. They also formed Strategic Alignment with all stakeholders to establish trust and mutual respect. There was a fully established shared accountability through ownership.
This presentation demonstrated what can happen when people/professionals come together. There were numerous break-out sessions, and one of the highest attended, in fact standing room only, was “Common Sponsor/FDA Audit Findings and How to Avoid Them by Ms. Athena Thomas-Visel, MA, ME, RQAP-GCP, PMP, RD, CCRP, Chief Quality Officer & Principal Consultant, Cliq Solutions. Of course, the information is very US-based. Yet, Cayman can learn what hasn’t worked in other countries.
I also attended sessions about clinical trials globally, namely in Asia, Eastern European countries and the Kingdom of Saudi Arabia. Needless to say, Clinical Research is expanding rapidly on a global basis. Cayman could do very well plan to grow this industry immediately. Other countries are working very hard on the Clinical Research infrastructure, legislation, and developing a local understanding of the potential value to any country’s population – but I digress. That’s another discussion.
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