Clinical Trial Summary
In order to expand neuroscience research and move laboratory advances to patients, there is a
need to integrate reliable clinical data with biologic information from patient tissue
specimens. The Neuroscience Research Repository (NRR) seeks to meet this need. The NRR is a
prospective database and sample bank created to collect information and samples for current
and future neuroscience research. The objective of this NRR is to develop a data and sample
repository for study of neurological conditions. A repository utilizing standardized
electronic health data and samples collected in a uniform manner serves to foster the ability
to perform research on current and future projects. Samples and data for clinical, genomic
and proteomic analysis will be provided to optimize their value for neuroscience research.
The NRR will enroll patients and collect clinically recorded longitudinal data for as long as
they are followed by the Neurosurgery service and up to an additional 5 years after being
released from care. Patients will be enrolled on admission to the service and samples will be
taken at three time points: Time One, within 24 hours of event (preferably first blood draw);
Time Two, within 48 hours of event; and Time Three, time of any residual tissue availability.
Family members of select groups of patients will also be approached for enrollment.
Samples and data will be labeled with a study code to maintain confidentiality. Samples and
data will be maintained in secure, limited access environments with back-up/redundancy
procedures in place. Sample inventory will be maintained with a bar-coding system. A duty to
warn clause will be included in the consent as will the determination of willingness to be
re-contacted for future research. Time of sample acquisition to time of sample processing
will be documented for quality control purposes. Freezers will be monitored for temperature
stability. Recipient investigators will be requested to provide feedback on sample quality.
Samples will be distributed to neuroscience investigators after approval from the
Neurosurgery Scientific Review Committee - Dissemination Review Committee and the Committee
for the Protection of Human Subjects (CPHS).
