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Research Management Group (RMG)

Clinical Trial Program and Resources


index of resources



clinical trial (ct) Rmg Study activation form

Clinical Trial RMG Study Activation Form

Memo to Faculty and Clinical Research Staff from Dr. Mark Cullen and Marcia Cohen re: Revised Intake Process for Industry Clinical Trials (effective Jan. 29, 2018) Download the memo pdf

To start the Clinical Trial administrative process, including budget development, contract review and negotiation, the Clinical Trial RMG Study Activation Form needs to be completed and submitted with all study-related documents (as listed on the form) to rmg_ct_intake@stanford.edu




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>>.




Clinical trials.gov registration facts

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

Per NIH Notice NOT-OD-16-149: The National Institutes of Health (NIH) is issuing this policy to promote broad and responsible dissemination of information from NIH-funded clinical trials through ClinicalTrials.gov. The policy establishes the expectation that all investigators conducting clinical trials funded in whole or in part by the NIH will ensure that these trials are registered at ClinicalTrials.gov, and that results information of these trials is submitted to ClinicalTrials.gov.

Stanford University School of Medicine Policy on Clinical Trials Disclosure (ClinicalTrials.gov) (Oct. 7, 2016)   
Link updated (11/16/2016) more >>

NIH Notice: 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.



NIH and FDA Clinical Trial Protocol and Template


Clinical Trial E-Protocol Tool and Template on the NIH Clinical Research Policy webpage >>
The electronic protocol writing tool aims to facilitate the development of phase 2 and 3 clinical trial protocols that require a Food and Drug Administration (FDA) Investigational New Drug (IND) or Investigational Device Exemption (IDE) Application. The development of the Phase 2 and 3 clinical trial protocol template was an initiative supported by the NIH-FDA Joint Leadership Council and the NIH Clinical Trial Stewardship Reform Task Force, and meets the standards outlined in the International Conference on Harmonisation (ICH) Guidance for Industry, E6 Good Clinical Practice: Consolidated Guidance (ICH-E6).

Download Clinical Trial E-Protocol Tool Template   

FDA Blog on the new template 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 CRISP USER GUIDE on this DoResearch webpage >>

Trials required to be entered in CRISP:


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.

Set up Study and Register Your Clinical Trial:
Under “Next Steps”

Regulatory Tools:
Under “ClinicalTrials.gov Registration and Results Posting”

Questions regarding registration?




industry funded clinical trials

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

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 measure, 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, device, diagnostic, treatment, intervention, or preventive measure.

2. The study will evaluate the effect of the drug, device, intervention on human subjects, or the review of patient care clinical data, with a focus on health-related biomedical or behavioral outcomes.

3.  The study must be performed primarily in patient care space, clinical-quality space, or locations treated as off-campus space.

4.  The study must be industry funded.




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


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:


CE faculty pi waiver



When do CE Faculty Need to Request a CE Faculty PI Waiver?

CE faculty must submit a CE Faculty PI Waiver request to obtain approval to be a PI or Co-PI for each external sponsored project/research grant they submit. CE faculty PI waivers are not needed for internal funding opportunities. However, CE waivers are required for Data Use Agreements, even if no funding is being received by Stanford.

CE Faculty PI waiver criteria and memo instructions



cancer clinical trials office (CCTO)

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 webpage: http://med.stanford.edu/ccto.html

CCTO services include:



investigator sponsored trials (iST) 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)



RMG Clinical Trial Start-up and Compliance Review Fee

FY19 RMG Clinical Trial Start-up and Compliance Review Fee memo >> (08/29/18)   

In line with the recent industry clinical trial fee increases announced by the Cancer Clinical Trials Office (CCTO), the Research Management Group (RMG) will similarly increase the Clinical Trial Start-up and Compliance Review Fee from current rate of $2,500 to $3,000 for each new industry-funded clinical trial, not including indirect costs.

In addition, the Amendment fees will increase from $500 to either $1,000 for a simple amendment or $2,500 for a complex Amendment, e.g., adding multiple arms or cohorts.

Please note the fees will be waived for industry-funded PI-initiated studies where the Stanford PI writes the protocol and serves as the (lead) PI on the clinical trial.

The fee increases will be effective for new studies submitted to sponsors after 9/1/2018. Budgets already submitted to sponsors or in negotiation with sponsors will not be changed to reflect the higher fee rates.

For questions about the RMG fee changes, please contact your Clinical Trial Research Process Manager (CT RPM).

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


Download the Industry Sponsored Clinical Trials IRB Review Fees memo, dated Aug. 20, 2018, from the Stanford Research Compliance Office Human Subjects Research and IRB Frequently Asked Questions and Resources webpage >>.

For questions about the IRB fee changes, please contact Elizabeth Caplun in the Research Compliance Office (650) 725-2903 or Elizabeth.caplun@stanford.edu.



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>>

No cost extension (nCX) for clinical trials only

This form is for Clinical Trials Only, not contracts or grants
Download fillable PDF form   pdf   (revised 04/19/2017)
Please complete and send to Cathi Blackwood in RMG at cathib@stanford.edu



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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