Stroke Patient Access Core (SPAC)
The Stroke Patient Access Core (SPAC) provides investigators with a centralized infrastructure for all aspects of stroke clinical research. These include research feasibility analysis, regulatory, recruitment, consenting, randomization, enrollment, follow-up, retention, and study closure.
O Research Feasibility Analysis: The SPAC team can provide analysis and evaluation through protocol review to determine the recruitment strategy for the individual study to optimize patient enrollment. The feasibility study will also provide information that may project study enrollment.
O Regulatory: Preparation of IRB submissions and interaction with the Human Research Studies Committee; and interaction with study sponsor.
O Recruitment: The screening process includes screening of daily acute ED stroke pages, all neurology inpatients, and stroke clinic outpatients. Most screens occur daily in real-time or at multiple time-points. We will approach all suitable candidates that meet criteria for the proposed study.
O Consent: The study consent may be presented to the patient, family, or significant others. The patient, family or significant others should understand the purpose, procedures, and the potential risks and benefits of the study through the consent process. The patient or the legal authorized representative may be consented. The consent process will be documented according to the federal guidelines (45 CFR 46.116).
O Randomization: After completion and documentation of the consent process, we will randomize the patient according to the specific protocol requirements.
O Enrollment: Patients may be enrolled per the specific protocol guidelines.
Follow-up: Visits will be scheduled according to the individual protocol schedule of events provided in the protocol.
O Retention: Initial patient interview will include at least two alternate phone numbers for family or significant others. Phone calls may be made to retain the patient and confirm follow-up visits.
O Study Closure: Complete necessary patient final visits and end of study documents.
O Data recording and data entry: We collect and track information, create source documents and work with the sponsor to streamline data recording and data entry.
Contact: To learn more about SPAC recruitment services, please contact Jill Newgent, RNBSN firstname.lastname@example.org: 314.747.3795, or Jenny Babka RNBSN 314.747.8794.