The NIH Definition of Clinical Research
Patient-oriented research: This type of research involves a particular person or group of people or uses materials from humans. This research can include:
Studies of mechanisms of human disease
Studies of therapies or interventions for disease
Studies to develop new technology related to disease
Epidemiological and behavioral studies: These types of studies examine the distribution of disease, the factors that affect health, and how people make health-related decisions.
Outcomes and health services research: These studies seek to identify the most effective and most efficient interventions, treatments, and services.
The Stanford Center for Clinical and Translational Education and Research (Spectrum)
Spectrum is a Stanford University independent research center funded in part by an NIH Clinical and Translational Science Award (CTSA). Its goal is to accelerate and enhance medical research, from basic discovery to improved patient care.
The Research Management Group (RMG)
RMG in the School of Medicine also provides services to support the Clinical Investigator.
Stages of Clinical Research
Spectrum provides support for all stages of clinical research:
Consultations for biostatistics, informatics, and bioethics; identifying collaborators.
Funding; contracts and approvals to complete before patients can be enrolled in a study.
Participant recruitment and enrollment; study tools and forms; regulatory compliance.
Final reporting to sponsor; requirements when publishing the results of your study.
ClinicalTrials.gov Registration Facts
Should you register your research project with ClinicalTrials.gov?
1. YES, if you want your study listed in the Stanford Clinical Trials Directory and on your CAP profile.
If you want your study to appear in the Stanford Clinical Trials Directory (v.2) then you must register your study at the NIH website, Clinicaltrials.gov. Stanford’s CT Directory only displays studies that it can pull from Clinicaltrials.gov.
2. YES, if you want to publish the results of your study.
If you wish to publish your study in a peer-reviewed journal, then it is highly likely that that journal will expect your study to have been registered with Clinicaltrials.gov. Over 1000 journals have adopted the policy of the International Committee of Medical Journal Editors (ICMJE) that requires registration in a publicly available register. The list of journals is at this link: http://www.icmje.org/journals.html
ICMJE requires registration for a wider range of studies than what we traditionally think of as “clinical trials” at Stanford. Here is their definition. Please note that almost any prospective study of medical or health interventions in human beings qualifies, including “observational” research. http://www.icmje.org/publishing_10register.html
“The ICMJE believes that it is important to foster a comprehensive, publicly available database of clinical trials. The ICMJE defines a clinical trial as any research project that prospectively assigns human subjects to intervention or concurrent comparison or control groups to study the cause-and-effect relationship between a medical intervention and a health outcome. Medical interventions include drugs, surgical procedures, devices, behavioral treatments, process-of-care changes, and the like.”
The ICMJE does not require posting of results for studies that are not otherwise required by law to do so.
3. YES, because in some cases, IT’S THE LAW
A smaller subset of studies are required by law to be registered with clinicaltrials.gov. The FDA Amendments Act of 2007 (FDAAA) required that most prospective studies involving regulated drugs, biological products, and medical devices must be registered on ClinicalTrials.gov. The law also requires reporting of “basic results” and adverse events for a subset of these studies. If you would like to determine if your study is required by FDAAA to be registered, you can follow the flowchart at this link http://grants.nih.gov/ClinicalTrials_fdaaa/docs/Flow_chart-ACT_only.pdf or contact Spectrum or CCTO for assistance.
4. When do I have to register my study?
ICMJE requires that you register prior to enrollment of your first study participant.
The law requires that a study be registered within 21 days of enrollment of the first participant. You must also update your CT.gov records at least every 12 months, or within 30 days of a change in recruitment status.
5. When do I have to post basic results?
The law requires that a subset of basic information be posted on ClinicalTrials.gov for any study in which the study product is approved for any use. For example, if you are studying an approved drug for a new use, you must register basic results. You must post this information within 12 months of the “Primary Completion Date” – defined by CT.gov as the final data collection point for the primary endpoint. Please note that you may not wait until complete data analysis of your project is completed to post basic results, if such completion falls outside the required time frame.
6. What are the consequences if I don’t register?
The consequences for non-compliance can include rejection for publication in top journals (even for studies not required by law to register), fines from FDA or NIH, or the withholding of grant funds -- for you individually or for the entire institution.
Questions about registrations?
Clinical Research Invoicing System for Participants (CRISP)
CRISP is a system that supports the tracking of patient events and is currently the invoicing process for industry sponsored clinical trials only. This is an auditable system that tracks clinical trial events and is used by both the department Financial Specialist and Study Coordinators along with Receivable/Cash Management (RCM) personnel. Invoices are to be processed through CRISP prior to A/R receiving the payment. This is for both invoiceable items and patient care costs processed through Case Report Forms (CRFs).
- HelpSU for CRISP - this is a pre-populated HelpSU that will go directly to the CRISP team.
Trials required to be entered in CRISP
- All industry-funded clinical trials that have activity or end dates on or after 1/1/2013 will be included.
Once a PDRF for an industry-sponsored clinical trial is approved, the SPO number will show up on the CRISP dashboard. Individuals who will initially have access to the record are the financial administrator and clinical trial coordinator listed on the PDRF, as well as Accounts Receivable.
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