Unlock the power to be your own CRO.

Clinical Research Coordinator Analysis

Screening and Enrollment Window Logistics

Finding: The protocol mandates completion of all extensive Screening/Baseline assessments (as detailed in Table 5-1, including informed consent often via LAR, comprehensive medical/neurological evaluations, numerous lab draws, and qualifying neuroimaging) *prior to randomization*, all within an extremely narrow therapeutic window of ≤10 hours from Large Hemispheric Infarction (LHI) onset for pre-Decompressive Craniectomy (DC) patients or ≤12 hours for post-DC patients (Inclusion Criterion 5). This compressed timeframe for acutely ill LHI patients presents a significant logistical challenge, increasing the risk of missed enrollment opportunities or protocol deviations due to intense time pressure on clinical and research staff. Recommendation:

1. Develop a site-specific "LHI Rapid Screening & Enrollment Workflow" map. This should detail parallel processing steps, clearly assigned roles (e.g., CRC, PI/Sub-I, ED/ICU nurse), and communication pathways for tasks such as immediate LAR identification and contact, concurrent chart review for initial eligibility, STAT ordering of qualifying CT/MRI and baseline labs, and expedited consent discussions.

2. Implement an internal "Potential LHI Study Candidate" alert system (e.g., pager, dedicated group chat) to rapidly mobilize the core research team and ensure immediate engagement with ED/Neuro-ICU primary care teams as soon as a potential participant is identified.

3. Proactively collaborate with the site's central laboratory to establish and confirm STAT processing capabilities and expected turnaround times for all protocol-required baseline labs (hematology, chemistry, coagulation, HbA1c, etc.). Specifically, seek clarification from the Sponsor if a recent, pre-existing HbA1c result (e.g., within 30-90 days, if available in the EMR) would be acceptable for eligibility determination in lieu of a new draw, to save critical time.

4. Prepare pre-assembled "LHI Screening Packs" containing all necessary documents: multiple copies of the ICF/LAR forms, pre-filled (where possible) lab requisitions, eligibility checklists, and contact sheets, to minimize administrative delays once a candidate is identified.

Rationale: Implementing these proactive operational strategies will significantly streamline the intensive pre-randomization process, enhance the site's capability to meet the narrow enrollment window for this critically ill population, reduce the likelihood of screen failures due to logistical bottlenecks, and minimize the burden and stress on site staff during high-pressure enrollment scenarios.