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Quicklinks

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:

  • Data Coordinating Center (designs and implements specialized, innovative clinical study data and management and visualization tools)
  • Biostatistics Shared Resource of the Stanford Cancer Institute
  • Biostatistics and Design Program of Spectrum
  • Design and review capacity of the Clinical and Translational Research Unit (CTRU)
  • Clinical and translational research (CTR) offerings in pre-award design consultation service

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
National Heart, Lung,
and Blood Institute
Allergy and Infectious Diseases, Microbiology (NIAID/DMID)

National Institute of Allergy and Infectious Diseases - Division of Microbiology and Infectious Diseases:

Stanford

Stanford Cancer Institute:

  • Investigator-initiated cancer clinical trials

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

 

Stanford IRB, and the Regulatory
Compliance Office

IND or IDE submission

Stanford Sponsor Investigator tools

Data and Safety Monitoring
Training:
Good Clinical
Practice; Regulatory
Knowledge
Additional Stanford
Resources

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