Open AccessAddressing the quality of submissions to ClinicalTrials.gov for registration and results posting: The use of a checklist
Author(s) -
Oswald Tetteh,
Prince Nuamah,
Anthony Keyes
Publication year - 2020
Publication title -
clinical trials
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.559
H-Index - 63
eISSN - 1740-7753
pISSN - 1740-7745
DOI - 10.1177/1740774520942746
Subject(s) - checklist , trial registration , protocol (science) , medicine , quality (philosophy) , clinical trial , medical physics , alternative medicine , psychology , pathology , philosophy , epistemology , cognitive psychology
US Federal regulations since the late 1990s have required registration of some clinical trials and submission of results for some of these trials on a public registry, ClinicalTrials.gov. The quality of the submissions made to ClinicalTrials.gov determines the duration of the Quality Control review, whether the submission will pass the review (success), and how many review cycles it will take for a study to be posted. Success rate for all results submitted to ClinicalTrials.gov is less than 25%. To increase the success of investigators' submissions and meet the requirements of registration and submission of results in a timely fashion, the Johns Hopkins ClinicalTrials.gov Program implemented a policy to review all studies for quality before submission. To standardize our review for quality, minimize inter-reviewer variability, and have a tool for training new staff, we developed a checklist.