On This Page
Quicklinks
Resources
- Clinical Informatics
- Clinical and Translational Research Unit (CTRU)
- Clinical Trial Methodology and Software
Locally developed methodologies and software - Department of Biomedical Data Sciences (BDS)
- Ethical research: CTSA Clinical Research Ethics Consultation Collaborative (CRECC)
- IRB (Human subjects research)
- Research Management Group (RMG)
- Spectrum Funding
- Stanford University Research Acronyms and Abbreviations
Study Design & Regulatory Affairs
Overview
This page provides guidance and resources for study design and start-up. Use the Quicklinks, and On This Page links to find information relevant to your research.
Getting Started | Study Design
| Center For Innovative Study Design (CISD) |
The Center for Innovative Study Design (CISD) was created in March 2009 to integrate the following services in the School of Medicine:
CISD provides training, workshops, and expert consultation and planning in clinical research informatics. For complete information on the services available visit the CISD website. |
Protocol Templates and Guides: NIH, Stanford, other
NIH
| NIH Collaboratory | Information about special considerations for pragmatic clinical trials at each stage of the research process. Includes real-world examples, best practices for designing and conducting pragmatic trials, resources, etc., and is the new home for all Grand Rounds content with upcoming and archived presentations. |
| NIH Research Methods Guidance | Information about design and analysis of trials that randomize groups or deliver interventions to groups; Group or Cluster-Randomized Trials (GRTs), or Individually Randomized Group-Treatment Trails (IRGTs.) |
| Phase 2 and 3 IND/IDE Studies |
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| Behavioral and Social Science studies | |
| National Heart, Lung, and Blood Institute |
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| Allergy and Infectious Diseases, Microbiology (NIAID/DMID) | National Institute of Allergy and Infectious Diseases - Division of Microbiology and Infectious Diseases: |
Stanford
Stanford Cancer Institute:
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Investigator-initiated trials are studies designed and written by Stanford investigators. Stanford Cancer Institute (SCI) investigators are required to use these protocol templates and guidelines for new investigator-initiated protocols: |
Other
| Common Protocol Template | |
| World Health Organization (WHO) | |
| Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) |
SPIRIT is an international initiative to improve clinical trial protocol quality by defining an evidence-based set of items to address: |
| Drug Study Designs | |
| CTSA Templates (Other Institutions) |
Children's Hospital of Pennsylvania (CHOP) Duke University School of Medicine
More protocol templates |
Regulatory Affairs
For regulatory requirements, support and consultations, visit the resources below:
Regulations and Guidance FDA, OHRP, NIH
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| Stanford IRB, and the Regulatory Compliance Office |
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IND or IDE submission |
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Stanford Sponsor Investigator tools |
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| Data and Safety Monitoring |
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| Training: Good Clinical Practice; Regulatory Knowledge |
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| Additional Stanford Resources |
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FDA Submissions - Devices (IDE)
The U.S. Food and Drug Administration website provides information for regulated industry on determining how to comply with the federal laws and regulations governing medical devices. See their Device Advice: Device Regulation and Guidance page for the following information and more:
- Overview of Medical Device Regulation
- Compliance Activities (Medical Devices)
- Postmarket Requirements
- Standards
Resources
FDA Submissions - Drugs & Biologics (IND)
The U.S. Food and Drug Administration website provides information for the Investigational New Drug (IND) Application. The site includes information and resources including:
- Pre-IND Consultation Program
- Guidance Documents for INDs
- Laws, Regulations, Policies and Procedures
- Emergency Use of an Investigational Drug or Biologic
- Related Resources, including Applications
Resources