Clinical Trials Compliance
If you are looking for information on industry-sponsored or privately funded clinical trials, please contact the 研究 Compliance Mailbox.
What is a Clinical Trial?
In 2015, 国家卫生研究院 changed the definition of clinical trial to “A 研究 study in which
一个 or more human subjects are prospectively assigned to 一个 or more interventions
(which may include placebo or other control) to evaluate the effects of those interventions
on health-related biomedical or behavioral outcomes.”
To qualify as a clinical trial, a study must meet all of these criteria. 研究
that involves individuals who are no longer living, studies of existing biological
specimens collected for a不her purpose, or 研究 that seeks to define an existing
measure are some examples of studies that are 不 clinical trials.
If you aren’t sure whether or 不 your study is a clinical trial, use the 国家卫生研究院决策工具.
国家卫生研究院 Single IRB (sIRB) Requirement
An 国家卫生研究院-funded clinical trial being conducted at more than 一个 site within the U.S.
may be subject to the 国家卫生研究院 Single IRB policy. 这个政策 不 适用于非大学.S. 网站. There are also certain 国家卫生研究院 awards that are exempt from
this policy, specifically career development (K), institutional training (T), and
fellowship (F) awards.
Any IRB that serves at the sIRB of record for 国家卫生研究院-sponsored 研究 must be registered
with the HHS Office of Human 研究 Protections (OHRP) and must have adequate expertise
to review the proposed study.
Please 不e that the 菠菜网lol正规平台 IRB 不是 currently registered to serve as the sIRB of record for multi-site 国家卫生研究院-sponsored
研究. You may use an institutional IRB that is associated with a co-investigator,
一个 of the participating 网站, or a commercial IRB. It is very important that you
work with your co-investigators to identify an sIRB as early in the proposal process
as possible, as there may be costs associated with sIRB review. These costs should
be included in your budget.
Training in Good Clinical Practice
You must have training in Good Clinical Practice (GCP) if you are an investigator
or clinical trial staff responsible for the conduct, management, or oversight of an
国家卫生研究院-funded clinical trial. Clinical trial staff members include 研究 coordinators,
study coordinators, co-investigators or students.
CGP training is meant to ensure that the rights, safety, and well-being of human subjects
are protected and the trial is conducted with rigor and integrity. It is also intended
to ensure that investigators are trained in how to collect reliable data.
菠菜网lol正规平台 provides investigators with access to GCP training through the Collaborative
Institutional Training Initiative (CITI). To access the GCP training:
- 访问 the CITI website
- Log in, or create an account using your 菠菜网lol正规平台 email address
- Select “San Jose State University Courses”
- Click on “add a course or update learner groups”
- Answer the required questions, and check the box in Question 4, “Good Clinical Practice (GCP)”
Proof of GCP training should be included in the study documentation and must be repeated at least every three years.
临床试验.政府 Registration and Reporting
All clinical trials funded in whole or in part by 国家卫生研究院 must be registered at 临床试验.政府. You must also submit the results of the trial on the site.
菠菜网lol正规平台 has an institutional account for 临床试验.政府, but you will need an individual
user account to register the study. 联系 研究 Compliance Mailbox to obtain this user account.
You will need your IRB approval number and a copy of your IRB-approved consent form
to register your study - please ensure that your study has been approved by the 菠菜网lol正规平台
IRB prior to requesting your 临床试验.Gov用户帐户.
研究Match for 菠菜网lol正规平台 研究ers
访问 研究Match is granted on a study-by-study basis; that is, investigators must individually register
每项研究. Registration takes only a few minutes and you must complete the process
一次坐下来.
There are two levels of access available to 菠菜网lol正规平台 investigators: feasibility access
and recruitment access.
Investigators may sign themselves up in 研究Match or may delegate recruitment
privileges to a study coordinator or other study team member (a proxy).
可行性的访问
可行性的访问 gives you the ability to view aggregate data on the registry population without an IRB-approved protocol. To register a study for feasibility access, you 必须:
- Be affiliated with 菠菜网lol正规平台
- Provide your 菠菜网lol正规平台 email address
- Create a 研究Match username and password
招聘访问
招聘访问 gives you the ability to recruit volunteers through 研究Match. To register a study for recruitment access, you must meet the same access requirements as for feasibility access. In addition, for 每项研究 you want to recruit for, you 必须:
- Be the principal investigator (PI) or authorized to recruit for the study on behalf PI
- Upload an electronic copy of your IRB approval letter, and an IRB-approved recruitment message to implement when using 研究Match.
Note: Individuals accessing as a proxy for the PI will be asked to indicate that, and to provide the study PI’s name, email address and ph一个 number.
