ClinicalTrials.gov Working Group

The ClinicalTrials.gov Working Group is composed of research professionals from various departments. This group acts as departmental liaisons to clinical trial investigators. Working Group members can assist investigators in completing their ClincalTrials.gov record and understanding how to use the Protocol Registration and Results System (PRS). In addition to their duties within departments, Working Group members set clinical trials research policy, and assists the IRB in assuring compliance with clinical trial research related regulations FDAAA 801 and 42 CFR 11.

 

 

HawkAct Determination Form

Complete this HawkACT Determination form to provide feedback to the IRB on the registration and results reporting requirements.

 

 

Request Help From a Working Group Member/Departmental Liaison

Click here to complete the form and request in-person help from a ClinicalTrials.gov Departmental Liaison.

 

 

Institute for Clinical and Translation (ICTS) Services

In addition to departmental liaisons, several ICTS members sit on the Working Group and offer unique services to clinical trial investigators. For a free consultation and more information on these services, please see the ICTS website.

 

ClinicalTrials.gov Working Group Charge

Purpose

  • Inform the UI IRB Compliance Program and UI Human Research Protection Program of researcher community needs regarding regulatory requirements specified by Section 801 of the Food and Drug Administration Amendments Act (FDAAA 801), ClinicalTrials.gov, and the Protocol Registration and Results System (PRS).
  • Identify opportunities for continuous quality improvement in facilitating the UI research community’s compliance with ClinicalTrials.gov requirements, as well as requirements from other entities, including but not limited to the International Committee of Medical Journal Editors (ICMJE), the European Medicines Agency (EMA), and the National Institutes of Health.
  • Develop an in-house network of researchers who can serve as a resource to others in navigating regulatory and institutional requirements related to clinical trials and identifying best practices. 

Responsibilities

  • Collaborate with the IRB Compliance Program and the Human Research Protections Program in the development and maintenance of policy and procedures that will improve compliance with regulations surrounding clinical trials;
  • Serve on “ad hoc” working groups that evaluate specific issues and recommend potential improvements to the Network for adoption by the IRB Compliance Program and/or UI Human Research Protections Program, as well as participating in educational activities related to ClinicalTrials.gov;
  • Raise potential issues within their respective division/area that are obstacles to complying with FDAAA 801 and requirements from other entities; and
  • Serve as a resource to other researchers in completing the ClinicalTrials.gov records.

Membership

Member Department Email Phone Number
Necole Miller Internal Medicine necole-miller@uiowa.edu (319) 353-5175
Jessica Gallagher Pediatrics jessica-gallagher@uiowa.edu (319) 467-5681
Kellie Bodeker Radiation/Oncology kellie-bodeker@uiowa.edu (319) 384-9425
Cena Jones-Bitterman Cancer Center cena-jones@uiowa.edu (319) 353-4596
Angela Childs Cancer Center angela-childs@uiowa.edu (319) 353-4595
Jackie Searls Surgery jackie-searls@uiowa.edu (319) 353-8204
Jess Fiedorowicz ICTS jess-fiedorowicz@uiowa.edu (319) 384-9267
Patrick Ten Eyck ICTS patrick-teneyck@uiowa.edu (319) 384-5242
Kimberly Sprenger ICTS kimberly-sprenger@uiowa.edu (319) 353-8862
Debra O'Connell-Moore ICTS debra-oconnell-moore@uiowa.edu (319) 356-1693
Zita Sibenaller Anesthesiology zita-sibenaller@uiowa.edu

(319) 356-8878

Gen Shinozaki Psychiatry gen-shinozaki@uiowa.edu (319) 384-4932
Debra Brandt OB/GYN debra-brandt@uiowa.edu (319) 384-8667
Wendy Beaver DSP wendy-beaver@uiowa.edu (319) 335-2123