The CMS has issued a National Coverage Determination (NCD) for routine costs in clinical trials, Section 310.1 (July 2007). Requests for routine fees for qualified clinical trials, as well as appropriate and necessary objects and services for the diagnosis and treatment of complications resulting from participation in all clinical trials covered by Medicare, require notification of an ClinicalTrials.gov identifier (NCT Number). Joint Statement of Intent (PROTOCOLE D`ACCORD): An agreement is a non-binding agreement that describes how NIAID and other government authorities or parties intend to cooperate on a number of related projects. An agreement may be of sufficient scope, complexity or sensitivity to require the approval of the NIAID director or project. ACTA is a simple and unequivocal document that clearly outlines the contractual obligations of both parties and is a language that, while perhaps not ideal for both parties, is acceptable to both parties. The adoption and use of ACTA will speed up the contract negotiation process and reduce the time it will take to commission industry-funded multi-center clinical trials. Agreements are often negotiated between NIAAs on the Department of Microbiology and Infectious Diseases (DMID) and external parties to cooperate in the implementation of a research project. The agreement covers the responsibilities and obligations of the parties specific to the objectives of the proposed research. However, outside of these networks, you can apply for funding for your own clinical trials, called clinical trials (IICTs) initiated by researchers. If you are considering an IICT application on NIAID, you must follow the required process or we will not accept your application.
For more information, see Investigator-Initiated Clinical Trial Resources. You need to consider several clinical trial factors in order to develop an adequate budget. We describe some of these factors below, but first a brief word on the importance of making sure your budget matches the magnitude of your research. Do you use NIH`s decision-making tool, does your study of human subjects conform to the nih definition of a clinical trial? To determine if your research is qualified as a clinical trial.