Noncompliant applications are most commonly the result of the investigator's failure to complete and have approved a Continuing Review Progress Report within the required time frame. These applications may also be the result of carrying out activities with human subjects that have not been previously approved.
Noncompliance status can have serious implications for a project:
- sponsor funds cannot be expended for any expenses incurred in such a period
- a report may need to be filed with the Federal government about the occurrence of noncompliance
- data from subjects enrolled during a period of noncompliance may not be used.