FDA Registration of Clinical Trial for WMDROC
PRS Information Registration of Clinical Trials Clinical trials are registered with ClinicalTrials.gov via a web based data entry system called the Protocol Registration System (PRS). ClinicalTrials.gov allows the reporting of trials that: Are in conformance with any applicable human subject or ethics review regulations (or equivalent) and Are in conformance with any applicable regulations of the national (or regional) health authority (or equivalent) ClinicalTrials.gov facilitates registration of trials in accordance with the International Committee of Medical Journal Editors (ICMJE) initiative requiring prior entry of clinical trials in a public registry as a condition for publication. Multi-site trials and multi-sponsor trials are susceptible to duplicate registration, thus care must be taken in how the trials are registered. For multi-sponsor trials it is the lead sponsor who should take responsibility for registration. It is critical that investigators and s...