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Definition of an Industry-Sponsored Clinical Trial
Research Policy Handbook 3.2
Industry-Sponsored Clinical Trials
Clinical trials are a subset of clinical research and must include all four of the following factors in order to qualify for the clinical trial indirect cost rate:
1. The objective of the study is either :
a. testing of drugs, devices, diagnostics, treatments, interventions, or preventive measures including testing for an unapproved indication or
b. data collection to increase knowledge that would lead to enhanced safety and efficacy of a drug or device.
2. The study must involve contact with humans. This includes studies that involve medical record reviews.
3. The study must be performed primarily in patient care areas and qualify as an off-campus project as outlined in the Research Policy Handbook 3.3 .
4. The study must be industry sponsored or funded.
For information regarding rates for Industry-Sponsored Clinical Trials conducted elsewhere, the investigator should contact the School of Medicine's Research Management Group or the Office of Sponsored Research
Clinical Trial Process Flow Chart
Clinical Trial Proces Process Flow Chart
(Revised Aug. 2006)
Clinical Trial Research Process Manager (RPM) Assignments
Clinical Trial RPM Assignment List (Revised May 2008) To view all RPM assignments, please see the RPM Department Assignment webpage.
Clinical Trial Process Roles and Responsibilities
The Clinical Trials Roles and Responsibilities website contains information on the roles and responsibilities of the PI/Study Coordinators, RMG/RPMs, the Office of Sponsored Research, SPCTRM , and the hospital with respects to the clinical trial process:
- Sponsor Contact with PI
- Process Initiation
- Parallel Processing (PP)
- Budgeting
- Award Completion
- Conduct of the Study
- Closeout
- VA/PAIRE Studies
- Cancer Center Clinical Trials Office
Cancer Center Clinical Trials Office
The Cancer Clinical Trials Office (CCTO) has staff to assist with clinical trial initiation for cancer studies at no charge to the investigator.
To request assistance from the CCTO see the following website.
CCTO services include:
- protocol development consultation;
- regulatory documentation preparation and tracking including IRB, GCRC, and IND/IDE;
- and study budget preparation and management for industry-sponsored clinical trials. RMG will review the final budget packet for compliance with University sponsored project requirements.
Investigator Sponsored Trials (ISTs) and Consent Observation
Stanford University’s Human Research Protection Program is fully accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP). That signifies that we meet their national standards to protect human research participants. As part of meeting their standards, we must provide additional oversight in two areas: Investigator Sponsored Trials (ISTs) and Consent Observation. Download memo 
(March 2006)
Clinical Trial Budget Development Fee
Clinical Trial Budget Development Fee Memo (Aug. 2007)
This memo contains information on the New Clinical Trial Budget Development Fee to support the cost of budget development and negotiation for industry-sponsored clinical trials.
IRB Review Fees
IRB Review Fee Memo 
(Dec. 2006)
This memo contains information on current IRB Review fees charged for the review of new industry-sponsored clinical trials, i.e., all studies which test an investigational drug or device on human subjects and are sponsored by private, for-profit entities.
Miscellaneous Clinical Trial Resorces
Stanford University Research Compliance Office Human Subjects webpage
Provides resources including IRB eProtocol submissions, policies, and training.
NIH Clinical Trial resource webpage (Clinical Trials.Gov)
Understanding Clinical Trials - how clinical trials work; potential benefits and risks
About ClinicalTrials.gov - background information, history and current status
What's New - recently published trials; trials in the news
Help - how-to information for finding trials in ClinicalTrials.gov
Glossary - terms related to clinical trials
More Resources - links to other sources of information on Clinical Trials
FDA Resources - Drug and Device information from the US Food and Drug Administration
NHLBI Clinical Research Guide
Preparing, submitting and managing a clinical research award can be challenging. This site is designed to guide potential investigators in organizing a clinical research application and to provide information on conducting a study and maintaining an award.
Non-Disclosure Agreements (NDAs) and Confidentiality Disclosure Agreements (CDAs) or Confidentiality Agreements
In the course of their Stanford work, Principal Investigators and other researchers may be asked to accept confidential, proprietary or restricted information, materials, software code or technology from a third party. The third party - a company or a government agency, for example - will require that the researcher sign a Non-Disclosure Agreement (NDA), sometimes also called a Confidential Disclosure Agreement (CDA) or Confidentiality Agreement.
These can come up in the context of several kinds of institutional arrangements, including equipment or software loans, technology licensing, data sharing agreements, or material transfer agreements. In these kinds of university agreements, a Stanford office, usually the Office of Sponsored Research or the Industrial Contracts Office, will be involved and can negotiate appropriate terms on behalf of the University.
In other cases, a third party may ask an individual at Stanford to sign such an agreement as part of an ongoing or proposed activity in which there is mutual interest, such as a clinical trial or potential collaborative research project. In these cases, the NDA is between the third party and the individual. The researcher cannot sign on behalf of Stanford University.
For complete information on Stanford's procedures and policies:
Dean of Research Office webpage on: Handling Non-Disclosure or Confidentiality Agreements
Subawards under Clinical Trials
The following forms are required for subawards under clinical trials and can be downloaded from the OSR Forms webpage:
OSR Form 31CT (Subaward Document Checklist)
OSR Form 33CT (Subrecipient Commitment Form)
This form should be submitted by all subrecipients for clinical trials during their proposal process to Stanford. It provides a checklist of documents and certifications required by sponsors, as well as an area for the authorized official to sign.
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