- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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California
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San Francisco, California, États-Unis, 94107
- Clinical & Translational Science Institute, University of California San Francisco
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Increased screening & enrollment for UCSF clinical studies
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Deborah G Grady, MD, MPH,FACP, Clinical & Translational Science Institute, University of California San Francisco
Publications et liens utiles
Liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- 12-08393
- UL1TR000004 (Subvention/contrat des NIH des États-Unis)
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .