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Screening Protocol for the Evaluation of Research Participants

2017年6月30日 更新者:National Institute on Drug Abuse (NIDA)

Evaluation of Potential Research Subjects - Screening Protocol for Clinical Studies

Background:

- The National Institute on Drug Abuse (NIDA) uses a standardized set of procedures to develop a pool of potential participants for research studies. Because some of the data collected during screening are used later for research, the screening itself is considered a study. An applicant to any NIDA study is considered a participant in NIDA screening.

Objectives:

- To identify, recruit, and screen participants for NIDA research protocols.

Eligibility:

- Individuals 18 years of age and older who are able to provide informed consent.

Design:

  • Individuals who are eligible for screening will undergo two interviews: a telephone interview and an in-person interview. The phone interview will determine eligibility for the in-person interview.
  • The in-person interview may require up to five visits to NIDA. The in-person visit will involve any or all of the following procedures: (1) full physical examination and medical history; (2) psychiatric interview; (3) psychological testing; (4) electrocardiogram; (5) samples of blood, urine, and hair; and (6) other minimally invasive procedures as directed by the research staff.
  • During screening, a photograph will be taken for confirmation of identity during subsequent visits for other studies.
  • No clinical care will be provided as part of screening.

研究概览

地位

完全的

详细说明

Through its clinical research protocols, the NIDA IRP attempts to: elucidate the nature of drug abuse and addiction; determine the potential use of new therapies, both pharmacological and psychosocial; and decipher the long-term effects of drugs of abuse on the development, maturation, function, and structure of the brain and other organ systems. In support of the IRP's work, the scientific goal of this screening protocol is to assess potential research participants' eligibility for NIDA IRP research studies. Screening will include medical and psychological tests and procedures. The data collected during screening are a unique and valuable source of information that aids in NIDA's mission. Therefore, a secondary goal of this protocol is to obtain data that characterizes the population of subjects contacting NIDA about research participation and to analyze data so obtained, such as that on the prevalence and consequences of HIV/AIDS, viral hepatitis, and related diseases.

研究类型

观察性的

注册 (预期的)

55000

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Maryland
      • Baltimore、Maryland、美国、21224
        • National Institute on Drug Abuse, Biomedical Research Center (BRC)

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

  • INCLUSION CRITERIA:

    1. Adults (at least age 18)
    2. Ability to understand and answer the questions as posed.

EXCLUSION CRITERIA:

1. Inability to provide valid informed consent.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 时间观点:预期

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2006年5月17日

研究完成

2010年6月17日

研究注册日期

首次提交

2009年12月18日

首先提交符合 QC 标准的

2009年12月18日

首次发布 (估计)

2009年12月21日

研究记录更新

最后更新发布 (实际的)

2017年7月2日

上次提交的符合 QC 标准的更新

2017年6月30日

最后验证

2010年6月17日

更多信息

与本研究相关的术语

其他研究编号

  • 999906412
  • 06-DA-N412

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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