Responsible Party Adherence to Final Rule Regulations: Corrections of Quality Control Issues within the Required Deadline


Author/Creator ORCID



Type of Work




BioMedical Science

Citation of Original Publication


Attribution-NonCommercial-NoDerivs 3.0 United States


The responsible party (RP) must correct or address apparent errors identified during quality control (QC) review of submitted clinical trial data within 15 days per the Final Rule. is obligated to post the data on the public database within 30 days from the initial submission. Records from the warehouse with initial submission of July 1, 2017 to December 31, 2017 were reviewed. The number of records for which the RP did or did not respond to QC reviewer comments and number of records that were posted within 30 days of initial submission were tabulated. Of the 1,114 records reviewed that did not meet QC criteria, 925 (83%) were resubmitted by the RP within 15 days and 189 (17%) were not resubmitted within 15 days. Strategies to improve percent resubmission include distributing monthly reports, providing annual training, revising existing email and help documents, simplifying review comments, and compiling specific examples of unacceptable data entries.