Screening Protocol to Evaluate Volunteers for NIA Approved Studies

Volunteers Clinical Trial

Official title:

Screening Protocol to Evaluate Volunteers for NIA Approved Studies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02091271
• Other study ID #: 999903335
• Secondary ID: 03-AG-N335
• Status: Completed
• Start date: February 28, 2003
• Est. completion date: March 11, 2020

Study information

• Verified date: March 2020
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The National Institute on Aging (NIA) Intramural Research Program (IRP) has a number ofiRB approved research studies involving human subjects, both normal volunteers and patients. As a means of identifying interested volunteers and other participants in the research process, this screening mechanism is established to identif'y potential eligible participants for NlA protocols.

To participate, volunteers/patients must meet the specific requirements of at least one of the available NlA research studies; this protocol serves as a first step for admitting volunteers/patients to an appropriate approved protocol and creating a contact database for approved NlA studies.

This protocol will facilitate their recruitment into NIA approved studies and provide NlA staff the opportunity to examine subjects where diagnostic observations can be documented and evaluated for research potential.

Description:

The screening protocol is designed to evaluate volunteers/patients for participation in IRB approved clinical studies of the National Institute on Aging (NIA). An additional purpose of this protocol is to develop a registry of individuals who have been evaluated through the NIA Clinical Research Unit screening clinic. To participate, volunteers/patients must meet the specific requirements of at least one of the available NIA research studies. This protocol serves as a first step for admitting volunteers/patients to an appropriate approved protocol, and it is used to develop a registry of individuals who meet eligibility criteria for existing research projects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5000
• Est. completion date: March 11, 2020
• Est. primary completion date: March 11, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

• INCLUSION CRITERIA:

1. All volunteers/patients who meet the criteria of an approved NIA protocol.

2. People with diagnosed or undiagnosed conditions

3. Patients may be eligible if they have rare, unusual, interesting or unknown conditions that require diagnosis

EXCLUSION CRITERIA:

1. Subjects unable to provide informed consent.

2. The volunteer/patient does not meet the criteria of any approved NIA protocol and does not wish to remain in the contact database for future studies.

3. Volunteer/patient has contacted the NIA Clinical Research Protocol Office and notified them that they would like to be removed and no longer contacted for NIA approved studies. They will be removed.

Related Conditions & MeSH terms

• Volunteers

Locations

Country	Name	City	State
United States	National Institute of Aging, Clinical Research Unit	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Develop a registry of individuals who meet eligibility criteria forexisting research projects		ongoing
Primary	Evaluate volunteers/patients for participation in IRB approved clinicalstudies at NIA		ongoing