All prospective Clinical Trials involving human subjects should be registered in compliance with the requirements of the International Committee of Medical Journal Editors (ICMJE). ICMJE member journals will not consider publishing trial results unless the trial is registered.
All clinical trials conducted at Children's Healthcare of Atlanta will be registered at http://www.clinicaltrials.gov/.
Clinical Trial (ICJME Definition)
Any research project that prospectively assigns human subjects to intervention or comparison groups to study the cause-and-effect relationship between a medical intervention and a health outcome.Studies designed for other purposes, such as to study pharmacokinetics or major toxicity (e.g., phase I trials), are exempt.
The investigator has three options for clinical trials registration:
Individual – if the clinical trial takes place outside of Children's facilities in a private practice office.
i. Individual Accounts may be registered without the assistance of the Children's Healthcare of Atlanta
ii. Investigators registering trials may refer to the Protocol Registration System at http://prsinfo.clinicaltrials.gov/
Children's Healthcare of Atlanta (as an Organization Account) – if the investigator is a Children's employee or a member of Children's medical staff.
i. Request the Children's research coordinator assigned to the study to complete registration or
ii. If no Children's research coordinator is assigned to the study contact the Children's Healthcare of Atlanta Clinical Trials Registration Administrator for assistance (Karen Querubin
Emory University (as an Organization Account) – if the investigator is an Emory faculty member
For more information about clinical trials, we offer some FAQ.