Clinical Research

Clinical research either directly involves a particular person or group of people or uses materials from humans. Examples include using human behavior or samples of their tissue linked to a particular living person.     

Authority

Mark Cullen, Senior Associate Dean for Research

Contact

Questions about this topic can be answered by:

Clinical Trials.gov Registeration

Non-cancer Studies: clinicaltrials-gov@stanford.edu

Cancer Studies: Sarah Pelta, (650)724-0513 (Stanford Cancer Clinical Trials Office)

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.

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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.

Register your study at the NIH website,  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.

Thousands of journals have adopted the policy of the International Committee of Medical Journal Editors (ICMJE) that requires registration in a publicly available register. 

View ICMJE site

3. YES, because in some cases,  IT’S THE LAW

A small 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, contact Spectrum or CCTO (Stanford Cancer Clinical Trials Office)

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?

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Stanford Resource: RMG - Clinical Trial Program and Resources

 The Clinical Trial Program and Resources from RMG (Research Management Group  in the School of Medicine) provides services to support the clinical investigator team.

RMG

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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

 

Have a question or suggestion?

Contact us via crisp-support@list.stanford.edu

CRISP 

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Stanford Resource: CCTO

The CCTO  (Stanford Cancer Clinical Trials Office) provides regulatory, administrative, research support, budget, and educational services to SCI investigators conducting cancer clinical trials.

ccto

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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

View more on Good Clinical Practice Training

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