During a training module this week, a group of monitors were discussing the importance of back-up coverage. Monitors that are conducting visits in the field know that juggling schedules can be very challenging. To provide thorough and consistent monitoring, experienced monitors are assigned to a clinical trial or a study team. Next, training is extended into the therapeutic area of research and sponsor specific trainings including SOPs and monitoring plans. But what about back-up coordinators - are they trained and ready?
Many monitors come from a research coordinator background in both device and drug research. During discussions with monitors that were formally coordinators all agreed that they felt their back-up coordinators were not truly ready to take on responsibilities in their absence.
The monitors did a little brainstorming and came up with the following 5 tips to help you get your back-up coordinators ready to report to duty!
- Early Training! Training of the back-up coordinator can occur at study initiation, when the coordinator is added to the study, or just before the primary coordinator is planning being out of the office. The monitors all agree in training the back-up coordinator early and often. Waiting until the day before the primary coordinator is scheduled to be out of the office does not allow enough time for adequate and thorough training.
- Shadowing visits! Allowing time for the back-up coordinator to shadow the primary coordinator for occasional study visits will allow for the back-up to see how visits are conducted and enable them to ask the coordinator questions. The back-up coordinator will also have the opportunity to meet subjects and become familiar with the patient population in the study.
- Share Helpful tools! Any helpful tools that the primary coordinator uses should be shared with the back-up coordinator, ahead of time! Don’t make the back-up coordinator hunt for information, phone numbers and contacts if the primary coordinator has already made tools to make visits easier!
- Study Visit Refresher Trainings! The primary coordinator can meet with back-up coordinators on a monthly or quarterly time frame to keep them aware of study amendments, enrollment updates, or upcoming visits.
- Prepare! One of the monitors, a former coordinator, would prepare study visit packets and worksheets one week ahead of time so that in the event of an illness or emergency, the primary coordinator could direct the back-up to where study related materials were filed. The packets would include the dates and times of the study visit, which visit the subject was being seen for in the protocol, and any corresponding orders for imaging or blood work that were required for that visit.
No matter what your back-up role; coordinator, monitor, major league pitcher, the whole team should be ready to put you up to bat at any time. How often does your back-up need to pitch hit for you? Do you have tips to share for being a better back-up? How does your site train or prepare back-up staff? Please feel free to share your tips here!
Photo Credit: Finesec