New Requirements for Registration and Journal Publication Loom
The International Committee of Medical Journal Editors has started to implement requirements related to sharing individual patient data in manuscripts that report clinical trial results. Beginning July 1, 2018, all manuscripts submitted to ICMJE journals that report clinical trial results must contain a data sharing statement. Clinical trials that begin enrolling participants January 1, 2019, or later must include a data sharing plan in the trial’s registration in ClinicalTrials.gov. Currently there are optional data elements available in the ClinicalTrials.gov database for data sharing. More information about these proposals, including a description of what the data sharing statement must address, can be found here.
Tracy Gatlin in the Office of Research Regulatory Affairs can help you register and update your trials or answer questions about registration. She can be reached by email at email@example.com.