Clinical trial NCT01717378: UCSF Research Participant Registry
Official title: Facilitating Enrollment Into UCSF Clinical Studies Via a Volunteer Research Participant Registry
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Any Disease or Condition
Healthy
Keywords: Patient Recruitment
Research Subject Recruitment
Research Subject Selection
Selection of Subjects
Health Surveys
Health Questionnaires
Health Interviews
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2012-10-30
Enrollment: 1541
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: General public. Anyone may join the UCSF Registry, but adult \& pediatric residents of the San Francisco Bay Area are targeted because of their proximity to UCSF research clinics.

Brief summary: The UCSF Clinical and Translational Science Institute (CTSI) Consultation Service provides recruitment services and facilitates the enrollment of research participants into UCSF clinical studies. The Recruitment Services will be accessible to all researchers at UCSF and affiliated institutions and will address the common problems that investigators encounter in the recruitment process.

Recruitment Services considered and integrated Committee on Human Research (CHR) and HIPAA regulations for ensuring human subject rights, participant privacy, and data security into the recruitment workflow and data collection/extraction methods. Recruitment Services, therefore, requests approval to implement these processes systematically for all studies that have already obtained CHR approval to begin recruitment activities.

Detailed description: The UCSF Research Participant Registry (http://registry.ucsf.edu) is a secure, standalone database that actively collects and stores data from willing volunteers who visit its website. The UCSF Registry is a cornerstone of the UCSF Recruitment Service (RS). Both the Registry and the RS are among several initiatives implemented by the UCSF Clinical \& Translational Science Institute.

The chief purpose of the RS is to facilitate the enrollment of research participants into UCSF clinical studies. The primary function of the Registry is to expand the pool of potential clinical research volunteers. The Registry stores self-reported identifiable health information in a searchable database that is compliant with the privacy requirements of the Health Insurance Portability and Accountability Act (HIPAA). This information is then used by the RS for the future identification and recruitment of potentially eligible participants for specific UCSF studies.

Registry participants whose data matches the major eligibility criteria for a specific study will be sent recruitment materials about the study. Contact information for the investigator or RS staff will also be included in the e-mailing. Participants are then free to choose whether to respond or ignore the study recruitment information.

Eligibility criteria: INCLUSION CRITERIA

* Adults age 18 years or older
* Minors/children with consent from parent or guardian (Parents or guardians must provide their own contact information and then complete the questionnaire using the child's health information.)

EXCLUSION CRITERIA

* Failure to provide consent
* Minors/children without consent of parent or guardian

Primary outcomes:
measure: Increased screening & enrollment for UCSF clinical studies
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Clinical & Translational Science Institute, University of California San Francisco
state: California
Study officials:
affiliation: Clinical & Translational Science Institute, University of California San Francisco
name: Deborah G Grady, MD, MPH,FACP
role: PRINCIPAL_INVESTIGATOR
References: