Are you part of a UAB team implementing pediatric research within Children's of Alabama (COA) space? 

Updates from COA to research study coordinators and teams are sent by us, the UAB Pediatric Research Office, when needed. Please contact us if you are new to conducting research within COA space.

All industry-sponsored budgets are negotiated, submitted to the UAB Clinical Billing Review's (CBR) Fiscal Analysis Process (FAP) for review and managed in OnCore. 

Developing Industry-sponsored Study Budgets for PIs in the Department of Pediatrics (DOP).

  • Review the industry budget negotiation flowchart.
  • Contact the appropriate DOP Financial Officer.
  • Incorporate the UAB Study Management Fee into the budget.
  • Use the COA Study Budget Costs form (Word) to request procedure costs from Pam Barlow, COA Research.  
  • Use the Clinical Fees and Billing Table of Contacts (PDF) to request costs from all other groups.

UAB Clinical Billing Review (CBR) Fiscal Analysis Process (FAP) and OnCore calendar requests

  • Submission for FAP review is required for any clinical trial/research project that includes clinical activities that may be provided and billed by a UAB Health System entity (aka UAB clinical billables).  The latest Clinical Billing Review workbook is on the UAB Clinical Trials Adminstrative Office site under Forms (v11.01.2019). 
  • UAB clinical billables are managed in OnCore. Please visit the OnCore Calendar Services page on the Center for Clinical and Translational Science website when a calendar build is needed.  The DOP does not have its own calendar builders. 
  • Contact Melissa McBrayer with questions about the FAP workbook and OnCore calendar requests.

COA Research Pharmacy 

  • Investigational Study Checklist for Coordinators (Read first!)
  • Release of Drugs for Human Research Use (Word)
  • FACTS about Billing for the Investigational Study Pharmacy (Read)
    *Contact Adrienne Travis, PharmD, COA Investigational Pharmacist, with questions.

Before you see a Research Subject at Children's of Alabama (COA)...

  • Complete a COA Research Pre-registration Form (Word)
    *Complete one form for every research visit that could generate a bill, including professional read fees.
  • COA New Patient (PDF or Word) Form is needed for any research subject that does not already have an existing COA Medical Record Number (MRN).
  • Complete and carry a COA Phlebotomy Services Request Form for Research Study with subject to the outreach lab for blood draws.  Even though there is not cost for a blood-draw, the form must be completed for COA's records. (PDF)
  • Submit any requests for research COA Laboratory Tests in I-Connect. 

Compassionate Use

  • Study Coordinators supporting PIs considering a Compassionate Use agreement with a drug company must contact Cathy Turner in Dr. Cohen's office.

UAB CCTS Standard Operating Procedures (SOPs) Library

  • A Workgroup developed template SOPs.  Templates are drafts and should be tailored to your area. 

Need IRB consent forms in Spanish? 

Adding Informed Consent Form (ICF) to a COA Medical Record

  • If your study activity occurs as outpatient visits and the study’s ICF states that it will become part of the participant’s medical record chart,
  • If your study activity involves in-patients, in order to ensure continuity of care/patient safety,
  • You are required to send an executed copy of each ICF to medical records in order to be added to the patient’s medical record.  A copy (including the participant's medical record number) should be created as a PDF and emailed to Terri Harris of COA Health Information Management.

Child Health Research Unit (CHRU)

The approved R2OP (Resuming Research Operations) for the 3rd floor CHRU is available from Cheryl Perry. 

In order to utilize the CHRU (UAB's outpatient pediatric research clinic space), or the centrifuge, you must apply for use. 

  1. Complete the 1-page CHRU Application and submit it with the required attachments (IRB/WIRB approval, assent/consent form(s), Human Subjects Protocol (HSP), research protocol) to Cheryl Perry
  2. Once approved, email Cheryl Perry and Melissa McBrayer (cc line) with a completed Reservation Template to  request date(s).
  3. The UAB Clinical Research Support Program (CRSP) is a fee-for-service entity that may provide study coordination, phlebotomy or regulatory form completion. CRSP works closely with DOP in support of pediatric research. Please contact Rhonda Corvalan of CRSP for more information and application.

How-to Request Research Study Monitor Access to COA Medical Records

If a research study monitor needs to visit COA Medical Records Department or needs I-Connect information, please follow the steps below to request, complete and submit the COA Researcher Project Provisioning Form.

  1. Requestor, typically a study coordinator, contacts the COA IT Customer Support Desk and requests the  COA Researcher Project Provisioning Form.  You may also email directly to request the form.
  2. Complete the form with dates and signatures by the sponsoring physician / researcher.
  3. Scan/email the form to  Alternatively, the form may be faxed to 205.638.6119 if scanning/email is unavailable. The turnaround time to approval should be 3 to 5 days unless the form is unsigned or there is information missing.
  4. The COA Provisioning Team notifies the requestor and sends an electronic copy to the researcher via email.
  5. The COA Provisioning Team also notifies COA Medical Records (William Woloszyn) and COA Risk Management Department (Kathleen Street) that a research request has been processed for that person and sends them a copy of the form to keep on file.
  6. A listing of research subjects should be sent to Tombi.Dowdell with a copy of the IRB approval letter.

Professional Opportunities and Training for Study Coordinators and other Research Team members

The PRO started the Pediatric Research Study Coordinator Lunch and Learn lunch-time event to share information and best practices for implementing pediatric research at COA. The target audience includes study coordinators, research nurses, clinical trial administrators and other key clinical research staff that support the implementation of pediatric research.

The 2020 Pediatric Lunch and Learns are at noon on April 7, August 26 and December 2 in the Bradley Lecture Center in Children's Harbor Building, 4th floor.  Contact Melissa McBrayer with questions or suggestions for future topics.

The NIH-funded Center for Clinical and Translational Science (CCTS) offers trainings, from lunchtime brown bags to a 6-week and 6-month certificate programs in the latest clinical and translational research competencies, to strengthen the research skills of every member of the research team.  Webpage with slides from the quarterly CCTS Clinical Trials Lunch and Learn are here.  Contact the CCTS for more information.

The Alabama SOCRA chapter of the Society of Clinical Research Administrators holds meetings on the 4th Wednesday of the month from 2-3p.m.  Learn more about the Certified Clinical Research Professional designation hereOnline trainings are available.  Contact Susan Branscum for more information.