Field Representative serves as “Site-ologist” Providing Insight and Guidance during Protocol Development

May 31, 2016

Baiba Berzins, MPH, has been with the ACTG Network since 1990 serving as the Study Coordinator at our Northwestern University Clinical Research Site in Chicago, IL.  In 1993, Baiba took on the newly created role of Field Representative in addition to her Study Coordinator duties. The creation of this role was in response to protocol development teams feeling as though they needed more insight from site personnel; they wanted someone on the team who could serve as an expert on the operations and limitations at sites. Since each protocol team consisted of a Virologist, Immunologist, Pharmacologist, etc., team members thought it would be extremely valuable for a Field Representative to serve as a “Site-ologist.” Baiba’s first protocol as a Field Representative was ACTG 241, the ACTG Network’s first triple-drug fast tracked protocol, and it was during that protocol development the team realized the important contribution she provided by her ability to evaluate aspects  of the protocol from a variety of perspectives.  While the Laboratory Technologist focused on the lab area of the protocol, and the Data Manager focused on the case report forms, they realized that the Field Representative was the person that pulled it all together.

“I cannot take credit for the phrase ‘Site-ologist;’ it was coined by my fellow Field Representative Cheryl Marcus, but it really does provide a great analogy for what the role brings to the table during protocol development,” said Baiba. “Field Representatives not only work to ensure protocols are written clearly and concisely, they also evaluate the feasibility and ease of study implementation and enrollment.”

Another area of protocol development where Baiba’s role as Field Representative provides valuable guidance is regarding inclusion and exclusion criteria. She notes that it is important to evaluate how narrow or wide the criteria should be when taking into account not just your site and its population, but also other sites that might participate in the protocol. Baiba also analyzes the clinical visit schedule and advises how it may or may not be doable based on location logistics, such as sites in rural communities versus those in heavily populated urban areas.

“Sometimes a change can be very minor, but can help to avoid a lot of headaches and keep the momentum of a study moving forward,” said Baiba. “For example, changing the verbiage from ‘will enroll’ to ‘will AIM to enroll’ can help to prevent study interruption if a protocol is just a few participants shy of meeting a very achievable enrollment goal.”

Baiba finds that being a contributing member of the protocol development team is another rewarding aspect of serving as a Field Representative. In fact, she still feels a strong bond with members of the ACTG 241 team whom she worked with over 20 years ago.  Baiba truly believes they valued her input and realistic viewpoint back then, as they still do now, and one way they have recognized her is by including her name on the mastheads of the published manuscripts.

“The success of the ACTG Network is due to the concerted efforts of many members who contribute their diverse expertise,” said Babafemi Taiwo, MD, Investigator, Northwestern University Clinical Research Site.  “Baiba’s combination of expertise in clinical research operations, extensive knowledge of the ACTG Network, and international experience has made her an exceptionally effective Field Representative for several protocols.”

Baiba and Dr. Taiwo are currently working on their third protocol together and that will be Baiba’s 12th for the ACTG Network.   Over the years, she has learned that it is not just organizational skills and attention to detail that helps her evaluate a protocol, it is also her ability to put herself in the shoes of other Site Coordinators. Baiba also notes that being able to quickly evaluate protocol updates and meet deadlines during the development process is crucial.

“I feel an obligation to read every word of a protocol and be available to provide insight and guidance whenever necessary,” said Baiba.”I have the reward of seeing my suggestions and input translated into tangible results and successful protocol implementation and that is one reason why I take my job so seriously.”

In closing, Baiba has a message to her fellow Field Representatives at sites across the ACTG Network:

“It takes a solid team to develop any ACTG Network protocol. Serving as the “Site-ologist” is a hugely important role.  All Field Representatives should be reminded that they are a key member of each successful protocol team. “