The National Institute of Diabetes & Digestive & Kidney Diseases

Data and Safety Monitoring Policy

NIDDK monitors all NIDDK-supported clinical studies and clinical trials commensurate with the degree of potential risk to study participants and the complexity of the study. Investigators of clinical studies that are not clinical trials, and that may pose more than minimal risks to participants, are required to discuss appropriate plans for safety monitoring with NIDDK staff.

All clinical trials require specific monitoring for participant safety and data integrity. Therefore, NIDDK has prepared the following guidance documents to assist investigators in complying with all NIH policies in formulating a data and safety monitoring plan. Some of the documents are informational and are presented in "pdf" format. The sample forms and tables are intended to be modified as appropriate by the user. Thus, these are presented as MSWord documents.

• NIDDK Data and Safety Monitoring Guidelines for Clinical Trials
  * (pdf-108kb)
  
  
• NIDDK Generic Data and Safety Monitoring Plan for Clinical Trials Requiring a DSMB.* (pdf-964kb)
  • Appendix A Sample Reports for Studies Requiring a DSMB (MSWord-359kb)
    
  • Appendix B Sample DSMB Charter (MSWord-113kb)
    
  • Appendix C Sample Conflict of Interest Form (MSWord-105kb)
    
    
• NIDDK Generic Data and Safety Monitoring Plan for Clinical Trials Not Requiring a DSMB.* (pdf-677kb)
  • Appendix A Sample Reports for Studies Not Requiring a DSMB (MSWord-269kb)
    
    

NIDDK Intellectual Property Option to Collaborator

Clarification of rights of all parties with respect to potential inventions and data access from clinical trials conducted with investigational agents supplied to the NIDDK pursuant to an agreement with a pharmaceutical collaborator.

NIDDK Guidance on Patents (pdf - 111kb)

* This file is in PDF format, which requires the free Adobe Acrobat Reader for viewing.

* Documents in DOC format require the free MS Word Viewer.

* Documents in PDF format require the free Adobe Acrobat Reader application for viewing.