NCT00593411: MDAnalyze

Neurological Surgery & Affiliated Services De-Identified Clinical Outcomes Database

Completed Last updated 29 March 2021

What this trial tests

trial in Central Nervous System Disorder in 732 participants. Completed in 9 June 2012.

Timeline

4 August 2005

Primary endpoint
9 June 2012

9 June 2012

Quick facts

Lead sponsor	University of California, Irvine
Status	Completed
Study type	OBSERVATIONAL
Enrollment	732
Start date	4 August 2005
Primary completion	9 June 2012
Estimated completion	9 June 2012
Sites	1 location across United States

Conditions studied

• Central Nervous System Disorder — all drugs for Central Nervous System Disorder →
• Spine Disease — all drugs for Spine Disease →
• Peripheral Nerve Disorder — all drugs for Peripheral Nerve Disorder →

Sponsor

University of California, Irvine

Who can join

7 and older, any sex, with Central Nervous System Disorder or Spine Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 It can be withdrawn by request of the patient at any time, but it does not expire unless the patient withdraws it, or the patient severs their patient care relationship with UCI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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.