Neurological Surgery & Affiliated Services De-Identified Clinical Outcomes Database
Public ClinicalTrials.gov record NCT00593411. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The collection of data from the myriad of services described is significantly impacted by NIH guidelines defining medical research involving humans as well as the recent implementation of HIPAA constraints which further complicate the conduct of retrospective clinical outcomes research. Simple case reports or case series analysis now involve IRB participation as well as voluminous documentation. The solution to this dilemma lies in developing and promoting secure, confidential prospective clinical databases for storing clinical data for subsequent retrospective de-identified inquiry. These databases function in a way analogous to "tissue banks" for subsequent basic science research. Patients consent to prospective entry of their clinical information into the database so long as they continue to be a patient with the Department of Neurological Surgery or the Departments or Divisions in association with the affiliated programs briefly described above. The consent is obtained during the patient's first inpatient or outpatient encounter in parallel with the HIPAA consent. It can be withdrawn by request of the patient at any time, but it does not expire unless the patient withdraws it, or the patient severs their patient care relationship with UCI Neurosurgery or the affiliated programs. The database is stored on a separate secure server maintained and backed up by the UCIMC Information Technology Department. Access to the database is restricted at multiple levels, with the majority of personnel allowed only limited access for data entry purposes. Only the database programmer/coordinator, the Department Administrator and the Chairman of the Department will have unrestricted access to the database. Authority for permission for levels of security clearance and access to the database, for other individuals, will be vested in the Chairman of the Department of Neurological Surgery. A separate IRB proposal will be formulated for individual study related to the acquisition of data from the de-identified database. Since these future studies will be performed on data sets derived from the previously consented subjects of this IRB-approved project, the requirement for additional consent forms are not anticipated. As a result IRB research proposals utilizing the database can be expedited. Once the specific study is approved, the investigator(s) are provided with the clinical information from the database in the form of a de-identified data set.
Study identification
- NCT ID
- NCT00593411
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 732 participants
Conditions and interventions
Interventions
Not listed
Eligibility (public fields only)
- Age range
- 7 Years and older
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 3, 2005
- Primary completion
- Jun 8, 2012
- Completion
- Jun 8, 2012
- Last update posted
- Mar 28, 2021
2005 – 2012
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of California, Irvine - Medical Center | Orange | California | 92686 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00593411, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 28, 2021 · Synced Sep 11, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00593411 live on ClinicalTrials.gov.