Screening Protocol to Evaluate Volunteers for NIA Approved Studies

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02091271

Enrollment

5000

Registered

2014-03-19

Start date

2003-02-28

Completion date

2020-03-11

Last updated

2020-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Volunteers

Keywords

Evaluation, Research, Healthy Volunteers

Brief 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.

Detailed 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.

Interventions

None listed

Study design

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* 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.

Design outcomes

Primary

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

Countries

United States

Outcome results