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.
NIDDK Guidance on Intellectual Property and Patents
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.
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.
Page last updated: November 25, 2008