The holiday season is a time of celebrations, travel, and time off, but for Clinical Research Coordinators (CRCs), it also brings a unique set of challenges. Clinical trials must run smoothly year-round, even when staff are on vacation, patients are less available, and shipping services are delayed.
This article highlights the key risks that can affect clinical trial operations during the holiday season and what CRCs can do to reduce safety and compliance problems during this busy time.
1. Reduced Staffing
Many research sites operate with fewer staff during the holidays. Coordinators, investigators, nurses, and even pharmacists may take time off, creating staffing gaps.
With fewer people available, tasks like patient visits, data entry, lab sample handling, and drug accountability may be delayed or missed. These gaps can cause protocol deviations and reporting issues, especially if no backup personnel have been trained in advance.
CRCs should stay aware of upcoming absences and plan coverage as early as possible.
2. Shipping and Delivery Delays
During holidays, shipping services experience backlogs. Couriers may run on shorter hours, and severe weather can also cause delays. For clinical trials, this becomes risky when:
- Study drugs are not delivered on time
- Lab samples arrive late at central labs
- Temperature-sensitive items are held too long in transit
These delays can lead to product quality concerns, missed visit windows, or data integrity issues. Keeping extra buffer stock and building longer timelines for shipments during this period can help reduce problems.
3. Limited Patient Availability
Many trial participants travel or spend time with family during holidays. Some may cancel or reschedule visits, while others may not respond to appointment reminders. Missed visits can lead to gaps in data collection and problems with visit-dependent dosing or assessments.
CRCs should maintain close communication with participants, offer flexible visit scheduling, and document all changes clearly to stay compliant.
4. Delayed Lab Testing and Results
Holidays can also affect lab operations. Some labs may close or reduce hours, leading to delays in testing, reporting, and reviewing lab values. This can impact safety monitoring, especially for trials that require lab results before drug dosing or enrollment.
CRCs must check lab availability ahead of time and adjust visit schedules or sample shipments accordingly.
5. Missed Temperature Monitoring
If investigational products or lab samples require cold chain storage, proper temperature monitoring is critical. During the holidays, when staff are away or distracted, it’s easier to miss temperature excursions or forget to document them.
Automated monitoring tools and setting up email/text alerts can help maintain control during these gaps. A missed temperature check may seem small, but it can lead to major issues with product integrity and patient safety.
6. Communication Gaps
Holiday absences can affect communication between site staff, sponsors, monitors, and vendors. Emails may go unread, and questions may remain unanswered, slowing down the entire study.
This can especially affect SAE (serious adverse event) reporting, protocol questions, or drug resupply requests. Having a list of emergency contacts and escalation procedures can help keep communication flowing.
7. Training of Backup Staff
Sometimes, temporary staff or less experienced team members are asked to step in during the holidays. If they’re not properly trained, they may struggle with data entry, informed consent procedures, or following protocol instructions.
CRCs should keep simplified instructions or checklists ready for essential tasks and offer quick refresher training where needed.
8. Delayed Monitor Visits or Data Review
Monitors may also take holiday leave, causing delays in source data verification (SDV) and query resolution. This can slow down timelines, especially for studies near database lock or final submissions.
Letting monitors know in advance about site closures and asking for flexible visit dates can help reduce this risk.
9. End-of-Year Reporting Pressure
For many studies, the end of the calendar year is a reporting deadline. Sponsors, CROs, and regulatory teams may rush to close visits, finalize documents, and submit reports.
CRCs may feel added pressure to finish tasks quickly, increasing the chance of errors or missed steps. It’s important to pace the workload and avoid skipping quality checks just to meet deadlines.
10. Increased Emotional Stress
Finally, it’s worth noting that holidays bring emotional challenges too. Staff may be tired or distracted, and patients may face stress, loneliness, or financial strain, all of which can impact compliance, visit attendance, or communication.
Kindness, flexibility, and good planning can go a long way in helping both staff and patients get through the season with fewer issues.
Conclusion
The holiday season is a busy time for everyone, and clinical trial sites are no exception. From reduced staffing and shipping delays to missed visits and communication gaps, Clinical Research Coordinators must stay alert to these seasonal risks.
By planning ahead, staying in close contact with both patients and partners, and keeping clear documentation, CRCs can help protect the safety, quality, and progress of their trials, even during the year’s most challenging weeks.
