Procedure for posting CFs
For any clinical trial conducted or supported by a federal agency or department or agency, Federal Regulations require the awardee of a grant to post one IRB approved informed consent form used to enroll subjects on a publicly available Federal Web site.
“Clinical trial” means a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes.
The PI must post:
- Only if the organization (UNMC, Nebraska Medicine, UNO or CHMC) is the lead site or grantee organization.
- Only clinical trials (defined above). As a general rule, if you reported to clinicaltrials.gov then you will also have to post the consent form.
- Only if conducted or supported by a Federal department or agency.
The PI only needs to post ONE consent form used to enroll subjects anytime during the course of the study
The consent form must be posted no later than 30 days after the last subject is enrolled
If your study is utilizes the Clinical Trials Monitoring System (CTMS) you will receive notification when your last subject is enrolled. The notification includes instructions about the requirement, and how to post to clinicaltrials.gov.
If your study does not utilize CTMS it is your responsibility to track subject enrollment, and post no later than 30 days after the last subject is enrolled.
Specific instructions on how to register with ClinicalTrials.gov and upload documents can be found here.