Navigator Team

The Georgia Clinical & Translational Science Alliance (Georgia CTSA) Trial Innovation Center's Navigator Team facilitates the flow of clinical research trials from concept to initial approval and implementation by assisting with maintaining compliance, quality, and innovation activities for each of the research offices at Emory University, Morehouse School of Medicine, University of Georgia, and other partner institutions of the Georgia CTSA.

• Collaborate with external and internal customers to evaluate services and implement quality improvement strategies for the clinical research community.
• Collect, upload, and manage new industry-sponsored clinical trial data in the Clinical Trial Automated System (CTAS) to monitor study progress throughout the pre-award process. CTAS is a web-based application developed to assist the Navigators with improving the pre-award approval process for new, clinical trials (per the NIH definition).
• Maintain the Investigator Dashboard allowing study teams to identify where studies are throughout the study approval process.
• Manage the electronic Investigator's Guide to Clinical Research orienting students, faculty, and staff to conducting research at Emory.
• Identify any preventable delays, data-driven gaps, or trends noted in the pre-award approval process as they become evident.
• Facilitate the generation of monthly, quarterly, and annual metrics through the CRSS Scorecard to measure the impact of services and programs.

Services provided to investigators

View the Rack Card

Investigator Dashboard

The Investigator Dashboard is available to Emory research faculty and staff and provides a window into the approval process-allowing study teams the capability of view just-in-time progress of studies pending approval. It features the ability for study teams to raise a query directly to a Navigator.

• Tracks all new studies (Federal/Non-Federal) with Emory Healthcare billables received in the Office for Clinical Research
• Studies remain viewable until the first patient is enrolled
• Departmental milestones include: RAS, OCR, OSP, IRB, OoQ & Winship (OnCore)
• Features ability for study teams to raise queries directly to study Navigator

Access the Investigator Dashboard

View Investigator Dashboard Instruction Guide

DSMB

The Georgia Clinical & Translational Science Alliance now offers studio consultations and resources that support investigators with the development of a Data and Safety Monitoring Plan and/or Board (DSMP/DSMB), that includes:

• Studio consultation
• NIH guided DSMB charter template
• Request the DSMB registry of participating members 
• Charter outline template
• Emory IRB guidance document

Access the DSMB Service Request Form (includes a Studio Consultation).

Rapid Response Team

The Rapid Response Team (RRT) works to streamline and facilitate the pre-award approval process for NIH and/or other Federally Funded Network Studies needing fast-track approvals.

• High priority, requiring emergency approval for survival
• Public health emergency
• Bioterrorist attack
• A significant or catastrophic event

View the Rapid Response Team Service Request Form and Submission Instructions.

Trial Innovation Network

The Liaison to the Trial Innovation Network (TIN) offers study investigators of multi-site trials the ability to request an initial consultation or specific resources for a trial, whether already funded or in the early planning stages. The TIN features:

• Single IRB
• Master contracting agreements
• Quality by design approach
• A focus on evidence-based strategies to recruitment and patient engagement