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
- Clinical trials
- 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.
Reasons to register your research project on ClinicalTrials.gov…
Compliance: Registration and results reporting is required by law for Applicable Clinical Trials, and according to the NIH Policy on the Dissemination of Clinical Trial Information for NIH-funded clinical trials.
Publication: Many journals require ClinicalTrials.gov registration prior to enrollment as a condition of publication.
Recruitment: The ClinicalTrials.gov website provides current information about clinical research studies to patients, their families and caregivers, health care professionals, and the public.
At what point does a study need to be registered?
Prior to IRB submission! If a study will be registered, the ClinicalTrials.gov registration (NCT) number must be entered in the eProtocol system prior to submitting the IRB application.
Learn more about requirements!
Visit the Spectrum CRQ website for detailed information on ClinicalTrials.gov and the NIH dissemination policy.
Review the Stanford decision tree, where investigators can evaluate the main requirements for registration and results reporting.
Email Spectrum CRQ at firstname.lastname@example.org.
For Cancer Center Studies, be sure you are working with the Cancer Clinical Trials Office (CCTO). Email them at CCTOemail@example.com.
Stanford Resource: CRISP
Clinical Research Invoicing System for Participants (CRISP) is a system that supports tracking 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 Sponsored Receivable Management (SRM) personnel.
Invoices are to be processed through CRISP prior to SRM receiving the payment. This is for both invoiceable items and patient care costs processed through Case Report Forms (CRFs).
All industry-funded clinical trials that have activity or end dates on or after 1/1/2012 must be entered in CRISP.
- Once a PDRF (Proposal Development Routing Form) for an industry sponsored clinical trial is approved, the SPO number will show up on the CRISP dashboard.
- The Financial Specialists and Study Coordinators listed on the PDRF and Accounts Receivable personnel will have access to the record.
Additional CRISP information and resources
Tutorial on Human Subject Research Protection and Good Clinical Practice
Required Tutorial on Human Subject Research Protection and Good Clinical Practice
Stanford provides access to required training through an interactive online tutorial, the CITI (Collaborative Institutional Training Initiative) Course in The Protection of Human Research Subjects.
This tutorial fulfills the requirement set for in RPH 5.7 Training in the Protection of Human Subjects in Research