<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01717378</url>
  </required_header>
  <id_info>
    <org_study_id>12-08393</org_study_id>
    <secondary_id>UL1TR000004</secondary_id>
    <nct_id>NCT01717378</nct_id>
  </id_info>
  <brief_title>UCSF Research Participant Registry</brief_title>
  <official_title>Facilitating Enrollment Into UCSF Clinical Studies Via a Volunteer Research Participant Registry</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, San Francisco</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The UCSF Clinical and Translational Science Institute (CTSI) Consultation Service provides&#xD;
      recruitment services and facilitates the enrollment of research participants into UCSF&#xD;
      clinical studies. The Recruitment Services will be accessible to all researchers at UCSF and&#xD;
      affiliated institutions and will address the common problems that investigators encounter in&#xD;
      the recruitment process.&#xD;
&#xD;
      Recruitment Services considered and integrated Committee on Human Research (CHR) and HIPAA&#xD;
      regulations for ensuring human subject rights, participant privacy, and data security into&#xD;
      the recruitment workflow and data collection/extraction methods. Recruitment Services,&#xD;
      therefore, requests approval to implement these processes systematically for all studies that&#xD;
      have already obtained CHR approval to begin recruitment activities.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The UCSF Research Participant Registry (http://registry.ucsf.edu) is a secure, standalone&#xD;
      database that actively collects and stores data from willing volunteers who visit its&#xD;
      website. The UCSF Registry is a cornerstone of the UCSF Recruitment Service (RS). Both the&#xD;
      Registry and the RS are among several initiatives implemented by the UCSF Clinical &amp;&#xD;
      Translational Science Institute.&#xD;
&#xD;
      The chief purpose of the RS is to facilitate the enrollment of research participants into&#xD;
      UCSF clinical studies. The primary function of the Registry is to expand the pool of&#xD;
      potential clinical research volunteers. The Registry stores self-reported identifiable health&#xD;
      information in a searchable database that is compliant with the privacy requirements of the&#xD;
      Health Insurance Portability and Accountability Act (HIPAA). This information is then used by&#xD;
      the RS for the future identification and recruitment of potentially eligible participants for&#xD;
      specific UCSF studies.&#xD;
&#xD;
      Registry participants whose data matches the major eligibility criteria for a specific study&#xD;
      will be sent recruitment materials about the study. Contact information for the investigator&#xD;
      or RS staff will also be included in the e-mailing. Participants are then free to choose&#xD;
      whether to respond or ignore the study recruitment information.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    This is a voluntary registry formerly managed by a unit within CTSI that was disbanded in 2013.&#xD;
    The registry has been dormant since that time.&#xD;
  </why_stopped>
  <start_date>March 2012</start_date>
  <completion_date type="Actual">February 2015</completion_date>
  <primary_completion_date type="Actual">February 2015</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>4 Years</target_duration>
  <primary_outcome>
    <measure>Increased screening &amp; enrollment for UCSF clinical studies</measure>
    <time_frame>4 years</time_frame>
    <description>By broadening the pool of potential volunteers, the Registry is expected to increase the number of screened &amp; enrolled participants in UCSF studies.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">1541</enrollment>
  <condition>Any Disease or Condition</condition>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Potential research participants</arm_group_label>
    <description>UCSF Registry represents a single recruitment pool of individuals who have consented to be contacted about future studies for which they may be eligible based on self-reported health information.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        General public. Anyone may join the UCSF Registry, but adult &amp; pediatric residents of the&#xD;
        San Francisco Bay Area are targeted because of their proximity to UCSF research clinics.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        INCLUSION CRITERIA&#xD;
&#xD;
          -  Adults age 18 years or older&#xD;
&#xD;
          -  Minors/children with consent from parent or guardian (Parents or guardians must&#xD;
             provide their own contact information and then complete the questionnaire using the&#xD;
             child's health information.)&#xD;
&#xD;
        EXCLUSION CRITERIA&#xD;
&#xD;
          -  Failure to provide consent&#xD;
&#xD;
          -  Minors/children without consent of parent or guardian&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Deborah G Grady, MD, MPH,FACP</last_name>
    <role>Principal Investigator</role>
    <affiliation>Clinical &amp; Translational Science Institute, University of California San Francisco</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clinical &amp; Translational Science Institute, University of California San Francisco</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://registry.ucsf.edu</url>
    <description>UCSF Research Participant Registry</description>
  </link>
  <verification_date>March 2015</verification_date>
  <study_first_submitted>October 26, 2012</study_first_submitted>
  <study_first_submitted_qc>October 29, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 30, 2012</study_first_posted>
  <last_update_submitted>March 9, 2015</last_update_submitted>
  <last_update_submitted_qc>March 9, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 11, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Patient Recruitment</keyword>
  <keyword>Research Subject Recruitment</keyword>
  <keyword>Research Subject Selection</keyword>
  <keyword>Selection of Subjects</keyword>
  <keyword>Health Surveys</keyword>
  <keyword>Health Questionnaires</keyword>
  <keyword>Health Interviews</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01717378
org study id: 12-08393
secondary id: UL1TR000004
nct id: NCT01717378
lead sponsor: 
has dmc: No
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.
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.
observational model: Cohort
time perspective: Prospective
measure: Increased screening & enrollment for UCSF clinical studies
time frame: 4 years
description: By broadening the pool of potential volunteers, the Registry is expected to increase the number of screened & enrolled participants in UCSF studies.
arm group label: Potential research participants
description: UCSF Registry represents a single recruitment pool of individuals who have consented to be contacted about future studies for which they may be eligible based on self-reported health information.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Deborah G Grady, MD, MPH,FACP
role: Principal Investigator
affiliation: Clinical & Translational Science Institute, University of California San Francisco
facility: 
country: United States
url: http://registry.ucsf.edu
description: UCSF Research Participant Registry
responsible party type: Sponsor