- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01717378
UCSF Research Participant Registry
Facilitating Enrollment Into UCSF Clinical Studies Via a Volunteer Research Participant Registry
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.
Studieoversikt
Status
Forhold
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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California
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San Francisco, California, Forente stater, 94107
- Clinical & Translational Science Institute, University of California San Francisco
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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Potential research participants
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.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Increased screening & enrollment for UCSF clinical studies
Tidsramme: 4 years
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By broadening the pool of potential volunteers, the Registry is expected to increase the number of screened & enrolled participants in UCSF studies.
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4 years
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Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Deborah G Grady, MD, MPH,FACP, Clinical & Translational Science Institute, University of California San Francisco
Publikasjoner og nyttige lenker
Hjelpsomme linker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- 12-08393
- UL1TR000004 (U.S. NIH-stipend/kontrakt)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .