Summary Level Results. Summary Level Results (including adverse event summaries) and a lay summary of the trial must be made available to the CAVD community no later than 6 months after study completion and be made publicly available no later than 12 months after study completion. To satisfy the requirement to share the Summary Level Results with the CAVD community the CAVD Member must provide the Summary Level Results to the CAVD Alliance Manager for posting to the CAVD members-only portal, or provide a link as to where CAVD Members can access these materials. The CAVD Member may choose the mechanism by which the Summary Level Results and the lay summary thereof are made publicly available, if a link as to where they 8 xxxxx://xxxxxxxxxxxxxx.xxx/ are stored is provided to the CAVD Alliance Manager for posting to the public CAVD website. For example, CAVD Members may use existing services such as at xxx.xxxxxxxxxxxxx.xxx or publish the clinical trial results in an open access publication that includes a lay summary. The Summary Level Results and the lay summary do not need to be separate documents or postings if the CAVD Member can achieve the goal of clearly presenting results to a scientific and non-scientific audience with a single document or posting.
Summary Level Results. The Bill & Xxxxxxx Xxxxx Foundation strongly believes that outcomes (results) of clinical studies must be shared with the trial participants, community stakeholders, HIV-vaccine investigators and the public in a clear and timely way. Disclosure of the results of a trial include a description of the details of the study (including its purpose, location, products being tested, and study population), the outcomes of the study including adverse reactions and their frequency, and contact information for the sponsor of the study. A lay summary of trial results must be communicated in a manner that supports Good Participatory Practice for biomedical HIV prevention trials3. The disclosure of Summary Level Results and a lay summary thereof is not intended to include participant-level data.
