Transition the study to another faculty member or close the trial in ClinicalTrials.gov prior to leaving Emory University.
Section 801 studies may only be registered by the Responsible Party. If this is an Applicable Clinical Trial (ACT) as defined by US Public Law 110-85, Title VIII, Section 801, ensure that it is appropriate for you to enter the trial and that it is not being entered by others, such as an industry or federal sponsor or coordinating center for a multi-center trial. You may enter studies which are not ACTs; however, if done, you will need to follow all the steps required of ACTs.
IND/IDE studies may only be registered by the IND/IDE holder. If the study is subject to U.S. FDA regulations, under an Investigational New Drug (IND) Application or Investigational Device Exemption (IDE), ensure that your organization is the IND/IDE holder before registering the study.
For NIH-funded studies, coordinate with the relevant Institute or Center. If this is a U.S. National Institutes of Health (NIH) funded study, registration should be coordinated with the sponsoring NIH Institute or Center to avoid duplicate registration. However, the NIH may designate the PI as the Responsible Party.
Multi-site studies are NOT registered by individual sites. If this is a multi-site study, it must be registered only once by the Sponsor (primary organization that oversees implementation of study and is responsible for data analysis) or the designated principal investigator (PI).
Coordinate with all collaborators before registering as the Sponsor. If the study has multiple collaborators, contact the other organizations to confirm that the study has not already been registered and to notify them that your organization, as Sponsor or as the designated PI, is registering the study.
Common delays encountered for receiving the NCT number and publication to the ClinicalTrials.gov website include:
Not “Approving” and “Releasing” the study for review with ClinicalTrials.gov (this is a two-step process). The Responsible Party must both “Approve” and “Release” the study before ClinicalTrials.gov will review the study record.
Not addressing QA Review Comments regarding studies after initial ClinicalTrials.gov review. The Responsible Party must respond to all comments generated by ClinicalTrials.gov staff after the initial review process is complete. The “QA Review Comments” must be addressed before the NCT number will be assigned and the study will be posted to the public website.