Service Request: Drug and Device Resource Service (DDRS) Consultation
The Project Specific Consultation Service includes a complimentary eight-hour consultation. Additional regulatory support beyond the eight hours can be obtained at an hourly rate of $72.00.
What Is a “Project”?
A project is a single IND or IDE application. If an investigator wishes to utilize the DDRS Consultation Service for more than one IND or IDE, he/she may do so.
Each IND or IDE will be considered a separate ‘project’ and each will be provided an eight-hour consultation period free of charge. After the eight-hour consultation period has ended, additional regulatory support can be provided on a fee-for-service basis, for each individual project.
During the complimentary eight-hour initial consultation period, Research Navigators investigate information about the project and the concerns of the investigator provided in the initial Connection Request as well as a completed Intake Questionnaire. After the initial analysis, the Navigators suggest appropriate templates, regulatory guidance documents, and facilitate consultation with other appropriate ICTR and JHU Institutional resources (e.g. Drug, Device, and Vaccine Development Core, Biostatistics Consultation Service).
Regulatory Support on a ‘Fee-For-Service’ Basis
Varying levels of regulatory support, including differing degrees of hands-on involvement by the Research Navigators, are available to investigators at fee-for-service rates. Customized fee-for-service support plans will be created with the investigator’s input to accommodate the specific needs of each project. A Statement of Work with estimate will be issued to summarize the services that can be expected under each project specific plan.