E&I strives to use common sense in the development of our processes to ensure that each of our requirements serve a specific, and useful purpose. We consider Quality Improvement to be an on-going process of development, for which we will always welcome feedback. If you believe our processes do not fit the needs of your project, we would like to hear from you.
When a sponsor or CRO elects to use a “central” IRB for their multi-site study, there are number of duplications that can occur in reporting and submission requirements. To reduce these duplications, E&I offers additional options to sponsors, including the development of specialized forms and processes for a specific study. Any variance from our routine processes must continue to ensure that our regulatory obligations, as well as those of the investigators are met.
This section is designed to provide guidance to sponsors and CROs related to E&Is submission process, reporting obligations, continuing review, and to ensure easy, open communication with our staff. Our desire is that the sponsor also provide guidance to E&I, through feed-back and on-going communication.
If you have additional questions not covered in this section, or prefer more personalized instruction, please contact the E&I administrative office for assistance. We are ready to help.