Adverse Events Module
For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.
Adverse Events Module path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Groups
Study -> Results Section -> Adverse Events Module -> Serious Events
Study -> Results Section -> Adverse Events Module -> Other Events
Adverse Events Module
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Position Statement on Active Outdoor Play | Position Statement Active Outdoor Play: The position statement summarizes the issues and research regarding children's access to outdoor play and provides recommendations for various stakeholders. It states that "access to active play in nature and outdoors - with its risks - is essential for healthy child development" and recommends increasing children's opportunities for self-directed play in all settings. The Position Statement includes recommendations for parents, educators, health professionals, administrators and various level of governments to address the barriers to children's outdoor play. It addresses common misconceptions and encourages that danger be differentiated from risk and outdoor play and fun be valued as much as safety (ParticipACTION Canada, 2015; Tremblay et al., 2015). | 0 | None | 0 | 0 | 0 | 0 | View |
| Risk Reframing (RR) Digital Tool | RR Digital Tool: This is the intervention condition. Participants in this condition completed the RR digital tool available at https://outsideplay.ca. Chapter 1: reflecting on their own childhood play activities; what they got out of these experiences; outdoor play activities of the children at their center; what they do to promote children's outdoor play; what gets in the way in promoting children outdoor play. Chapter 2: imagining themselves in six video segments where they must decide how to communicate with parents; and, whether they allow children to engage in rough and tumble play, play at heights, play with tools, play at speed/mud play, and resolve conflicts amongst themselves Chapter 3: reflecting on their barriers and things that helped them promote and support the children's outdoor play at their center. Participants to assess whether there is anything they want to change to set a realistic goal, outlining steps for attaining that goal. | 0 | None | 0 | 0 | 0 | 0 | View |