Research Management Group– (RMG)

Clinical Trial Program and Resources

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OTHER resources

 

What's New

Spectrum Clinical Trials website updates
more >>

CT Start up checklists for PIs and Study Coordinators more >>



ClinicalTrials.gov Registration Facts

ClinicalTrials.gov Registration Facts DoResearch webpage on the importance of registering your research project.
More >>



Clinical Research Invoicing System for Participants (CRISP)


CRISP is a system that supports the tracking of patient events and the invoicing process for industry sponsored clinical trials. The UAT and pilot finished successfully, and the system is being rolled out to departments that have industry sponsored clinical trials.

Link to (ORA) CRISP Resource webpage >>

Trials required to be entered in CRISP:

  • Any new or existing industry-funded clinical trials that have activity/end dates after 01/01/2013 will be included.
  • Industry-sponsored clinical trials that end on or before 12/31/2012 will not have to be entered in CRISP, but can be at the department’s discretion. Based upon the success of the pilot phase and enhanced capabilities CRISP has to offer we strongly encourage you to do so.

Benefits
Clinical Coordinators will be able to track patient events, Accounts Receivable will have the information needed for timely submission of invoices, and the PIs and department financial administrators will have up-to-date financial information on the trial at their fingertips via individualized summary screens. CRISP will facilitate the financial aspect of clinical research by listing all invoiceable items in one place. Invoicing will be more accurate, resulting in more revenue recovered for projects. Accounts receivable collection and the posting of available funding on expenditure statements will also be accelerated by the adoption of CRISP. Once the sponsor is invoiced, the invoice number and payment status will be available in CRISP.

 



Spectrum Clinical Trials Website

Stanford's Clinical Trials Directory
On Wednesday, March 6, 2013, the Information Resources & Technology (IRT) department launched a new version of Stanford's Clinical Trials Directory. The development of this new system was led by Dr. Harry Greenberg, Senior Associate Dean for Research, and Michael Halaas, Chief Information Officer for the School of Medicine, as well as representatives from the school and both hospitals.

This new system imports Stanford trials from clinicaltrials.gov and makes them available to investigators and clinical service line specialists to categorize and publish to our Stanford websites. It also uses latest technologies to allow various websites display trials data directly on their websites.

In your CAP profiles, investigators will be able to accept or reject newly imported trials that appear to be associated with them, similar to the way publications are currently managed. Also, optionally, investigators can manage key information about the trial that may not be available on clinicaltrials.gov, such as the Stanford contact person and Stanford's recruiting status.

Stanford Clinical Trials WebSite
Please review the Stanford Personnel section on this Spectrum webpage.
http://spectrum.stanford.edu/researcher-resources/clinical/otc/stanford-clinical-trials.html

Set up Study and Register Your Clinical Trial:
Under “Next Steps”
https://spectrum.stanford.edu/accordions/set-up-study/?ch2=18

Regulatory Tools:
Under “ClinicalTrials.gov Registration and Results Posting”
https://spectrum.stanford.edu/accordions/operations-training-and-compliance/?ch2=-1&ch1=3



Questions regarding registration?

Non-cancer studies:
Linda Walker, Spectrum, at lswalker@stanford.edu or 650-498-6498

For cancer-related trials:
The Cancer Clinical Trials Office (CCTO) at ccto-website@stanford.edu or 650-724-0153

 


NIH Notice NOT-OD-08-014: Expanding the Scope of ClinicalTrials.gov Registration

This NIH Notice NOT-OD-08-014 provides guidance and policy updates for NIH Clinical Trial grantees regarding the registration of clinical trials in ClinicalTrial.gov.




Clinical Trial (CT) Research Process Manager (RPM) and Contract Officer Assignments

Effective October 3, 2011, the Office of Sponsored Research (OSR) Contract Officers assigned to negotiate clinical trial and clinical research contracts are now part of the Research Management Group (RMG).
Memo 09/14/11>>PDF

To view all Clinical Trial RPM and Contract Officer assignments, please see the RPM and Clinical Trial Contract Officer Department Assignment webpage>>.

 


Industry Funded Clinical Trials


Definition of an Industry-Funded Clinical Trial Research Policy Handbook (RPH 13.3)

Industry-Funded Clinical Trials (revised)
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 a drug, device, diagnostic, treatment, intervention, or preventive measures including testing for an unapproved indication or
b. data collection, or review of data generated or acquired in a clinical setting, to increase knowledge that would lead to enhanced safety and efficacy of a drug or device.

2. The study must involve contact with human subjects or the review of patient care clinical data.
3. The study must be performed primarily in patient care or clinical space, and qualify as an off-campus project as outlined in the Research Policy Handbook (RPH 15.1).
4. The study must be industry-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 Process Roles and Responsibilities and
Start Up Checklists for PIs and Study Coordinators

 

Start Up Checklists for PIs and Study Coordinators

 


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 >> (Oct. 2012)   

In September 2007 we instituted a Budget Development Fee of $2,500 on all new industry-funded clinical trials. The fee was implemented as a result of increased administrative and procedural compliance requirements. These requirements include staff effort to conduct a coverage analysis, align the contract and budget with the protocol and consent, negotiate the budget with the sponsor, and coordinate the budget with the department staff, IRB, Spectrum OTC, Stanford Hospital and Clinics/Lucile Packard Children’s Hospital.

Effective November 1, 2012, the Budget Development Fee will increase to $3,200 for new studies. The increased fee will be budgeted and negotiated on new industry-funded clinical trial budgets prepared by either the Research Management Group or the Cancer Clinical Trials Office.

In addition, the RMG will implement a $640 Budget Amendment Fee for sponsor amendments for budget revisions. The new amendment fee will be budgeted and negotiated for only new industry-funded clinical trials received in RMG starting November 1, 2012. Existing awarded studies will not be impacted. The CCTO already has an Amendment Fee that will remain at $640.

Please note: these fees are only applicable to industry sponsored clinical trials and are not applicable to clinical trials supported by non-profit foundations, voluntary health organizations, and government sponsors.




Clinical Trial IDC Rate Increase Memo


Clinical Trial IDC Rate Memo  (Nov. 2009) pdf file
Effective Jan. 1, 2010, the indirect cost rate for industry sponsored clinical trials will increase from 25% to 28%. This rate will be applied to new studies received in the Research Management Group on or after Jan. 1, 2010. Studies currently in the budgeting process in RMG or previously awarded by OSR at the 25% rate will retain the 25% F&A rate for the life of the study. (Note: the Clinical Trial definition above from RPH 3.2.)  The new rate is based on information about industry-sponsored clinical trial IDC rates collected in the Fall-Winter of 2008-09 from about 70 other medical institutions. The survey indicated rates ranged from 25% to 60.1%. For questions, please contact your CT RPM or Debbie Leong-Childs, Associate Director, in RMG.




IRB Review Fees

 

IRB Review Fee Justification Memo (April 2012) PDF
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, device, or treatment on human subjects and are sponsored by private, for-profit entities. The base fees for IRB review remain at $2,000 for new studies and $1,000 for continuing review. However with the increase in the Clinical Trial IDC rate, the total fees will be $2,560 and $1,280 respectively.

 



Miscellaneous Clinical Trial Resources



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.  

Spectrum Website>>

 

 


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. If the sponsor or third party insists on an institutional signature for a Clinical Trial NDA, contact your Research Process Manager (RPM) in the Research Management Group for guidance.

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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