Pediatrics Business Services

Clinical Research Administration

The Clinical Research Administration facilitates and supports clinical research conducted at UCSD sites and Rady Children’s Hospital San Diego by the Department of Pediatrics faculty.

A Clinical Trial is defined as; the controlled, clinical testing in human subjects of investigational new drugs, devices, treatments, or diagnostics, or comparisons of approved drugs, devices, treatments, or diagnostics, to assess their safety, efficacy, benefits, costs, adverse reactions, and/or outcomes. Such studies may be conducted under an industry-developed protocol or an investigator-developed protocol.

In addition, a clinical trial is most often used in conjunction with obtaining new drug or device approval from the U.S. Food and Drug Administration. Although they can be designed with the sole purpose of collecting and analyzing data about an approved drug or device in order to contribute to medical knowledge about the treatment of a disease or medical conditions.

For Industry-Initiated Clinical Trials: Sponsor writes the protocol and pays all costs for study, click here.

  • For Investigator-Initiated Clinical Trials: P.I. writes the protocol, and receives full or partial funding from the Sponsor, click here.
  • For an Investigator-Initiated vs. Industry-Initiated Clinical Trials Quick Reference Guide, click here.
  • For Frequently Asked Questions, click here
  • IRB – Getting started: http://irb.ucsd.edu/

CONDUCTING CLINICAL RESEARCH AT RADY CHILDREN’S HOSPITAL-SAN DIEGO

At Rady Children’s, we initiate, assist, track, and support clinical research conducted at Rady Children’s Hospital-San Diego by the Department of Pediatrics faculty.

We are responsible for:

  • Facilitating the initiation of new research protocols involving RCHSD. To get started complete a Project Initiation Form. This form can be obtained by sending an email to Research@RCHSD.org.
  • Assisting with logistical issues that arise during the initiation and conduct of research projects.
  • Tracking all research projects conducted at RCHSD to insure ongoing compliance with applicable laws, regulations and policies.
  • Working with the department business office to provide pre-award services for investigators seeking grant funding or participating in sponsor initiated clinical trials.

Contact

Ed Quigley, Research Administration Officer
858-966-6228 equigley@rchsd.org

Questions and requests regarding research at RCHSD can also be sent to research@RCHSD.org