Concept Implementation

Atlanta WIHS Approved Concept Sheet Implementation Process

This document is designed to guide principal investigators affiliated with Emory who are new to WIHS and who have recently approved WIHS concept sheets through the WIHS study process at Emory. There are many Emory WIHS resources available to Emory PIs to help them accomplish their proposed research, including data management, regulatory assistance, and biostatistical support. In order to fully benefit from the Emory WIHS resources available, it is important to follow the concept sheet process outlined below. The Emory WIHS team wants to facilitate completion of approved concepts and will do their best to assist PIs with their concepts.

Note that WIHS is a multi-site study and this document describes the process for principal investigators affiliated with Emory who have approved concept sheets, regardless if there are WIHS collaborators at other sites involved. Utilizing the Emory WIHS team is the most efficient way for PIs to quickly begin research on their concepts. Start preparations early, as studies needing Emory IRB approval are reviewed on the rolling basis. It takes at least 3 weeks, and on average 7 weeks to get IRB approval. If the study needs full board review, it may take even longer. Their approval is required prior to a final review and approval by the Grady Research Oversight Committee, who holds their meeting once a month on a rolling basis.

As a result, all questions should be directed to the Emory WIHS team early upon concept submission and approval, before contacting WIHS team members at other sites.

Important Contacts

Atlanta WIHS PI’s: Oversight of Atlanta WIHS.

Project Director: Coordination and oversight of all Atlanta WIHS projects

Data Manager: Variable request, preparation of original dataset, and extensive knowledge of WIHS data available.

Regulatory Coordinator: IRB and OCR applications, Biosafety approvals, and Emory/Grady ancillary approvals.

Biostatistician: Preparation of analytic datasets, data analysis and statistical support.

Lab Manager: Coordinating samples processing, storage and/or Repository use.

List of Abbreviations

CS: Concept Sheet
DM: Data Manager
EC: Executive Committee
GROC: Grady Research Oversight Committee
IRB: Institutional Review Board
OCR: Office of Clinical Research
OOQ: Office of Quality
PI: Principal Investigator
PD: Project Director
WIHS: Women’s Interagency HIV Study
WDMAC: WIHS Data Management and Analysis Center (Data Coordinating Center for WIHS, located at Johns Hopkins)

Key Steps

The Flow Chart (below) describes the key steps involved in study implementation after you receive approval of your Concept Sheet from the WIHS EC. As a first step, please forward your approval email to Atlanta WIHS DM (see contact list). Please, expect that soon after your approval receipt you will receive an invitation for an initial meeting with Atlanta WIHS PIs, PD, DM, IRB Coordinator, and Biostatistician. During that meeting, we will review your project and determine in which way Atlanta WIHS team may facilitate its implementation; we will also identify next steps (e.g., IRB applications) and schedule follow-up meetings with relevant team members (e.g., IRB Coordinator, DM, Lab manager, or Biostatistician). We will thus help you to quickly and efficiently launch your study. During the study implementation phase, please expect periodic meetings/calls with Atlanta WIHS PIs to ensure smooth progress of your study. Lastly, please be aware that there are specific steps involved in the study completion (e.g., submission of the manuscript draft to WDMAC for review) outlined in the Flow Chart below.

Implementation Flow Chart