IRB Submission

Information on the IRB submission requirements and process , including reference guides, deadline dates, ISMMS conditional office reviews (if applicable), as well as training and workshops offered at ISMMS to provide further guidance in the submission process.

Start GCO Application

Detailed checklists and instructions that guide researchers through the process of completing an InfoEd application for industry initiated clinical research studies.

Triggering Event (TE)

Every time a project is submitted, and at the time of continuing review of an existing project, the Triggering Event (TE) Form must be completed in eDisclosure Management System (eDMS). What A Triggering Event (TE) is used by the institution to generate notification...

Budget Development and Negotiation

Tips, tools and services offered by the Financial Administration of Clinical Trials Services (FACTS) Office to assist teams develop and negotiate budgets for industry sponsored clinical trials. Information regarding fee schedules and BRANY can also be accessed here.

Approvals Needed for Research

Refer to the list of institutional committees, Departments and Institutes that may require review and oversight based on the nature of the research study.

Conducting a Device Study

 Before You Begin Contact Inna Bender or Paulette Palmer for the specific procedures required for device trials. Medicare Approval for Investigational Device Exemption (IDE) Clinical Trials Medicare approval for IDE trials is a two-step process that includes:...

Medicare Coverage Analysis (MCA)

The FACTS office process for tracking and preparing a Medicare Coverage Analysis (MCA), a document that determines the appropriate payor (i.e. sponsors, Medicare, or third-party) for each item and service required by a clinical trial.

More

Recruitment and Retention

Internal and external resources available to assist research teams with recruitment efforts and retention plans, including translation services.
More