The IRB has released a new HRP-503 Protocol document, which was designed to make completing the document more efficient for researchers and reduce the number of revisions during the review process.
While ClinicalTrials.gov encourages researchers to use the Modernized Protocol Registration and Results System, users are advised to switch to Classic PRS for several critical tasks.
Part two in a series of articles highlighting frequently asked questions to comply with results reporting for ClinicalTrials.gov includes guidance on the Quality Control review process, protocol and statistical analysis plans, and appendices. (See part one here.)
In the second part of a two-part series, “Research Roundtable” highlights additional elements of the “Study Registration” FAQ section from ClinicalTrials.gov.
ClinicalTrials.gov has an extensive FAQ section ranging from general to investigation-specific. This edition of “Research Roundtable” highlights a selected FAQ, “Study Registration.”