Table 3.

Adverse Event Reporting Recommendations

Recommendations	Rationale
Recommendation 1. Studies should report the data generating process underpinning AE collection as part of the AE report in terms of how: (1) AEs were gathered, and details of training provided to staff in gathering AEs; and (2) AE data is accessed such as by reporting frequency of patient contacts or how often clinical notes are accessed. The iCharts consortium have produced best practice guidelines.23	From assessing AE reports, it can be unclear how the AE reports were gathered as this information was not routinely reported. For example, it was not always clear whether researchers asked participants about AEs directly, or whether AEs were only logged when spontaneously reported or gathered from case notes.
Recommendation 2. Studies should plan from the start that AE reports form part of the outcome data presented in trial reports and highlight to participants that AE data might be shared with other researchers. For example, consent forms should highlight participants to the fact anonymized safety information will be shared with other researchers.	There was a low response rate to requests made by the iCharts consortium to researchers asking them to share AE reports. There may be many reasons for this. Data sharing initiatives usually focus on primary outcome measures and AE reports may not have been traditionally considered as data that can be shared with other researchers.
Recommendation 3. Researchers should ensure that all AE reports are written in enough detail so that independent researchers can understand what happened to the participant when fully anonymized reports are shared and how many participants were affected. For example, if a participant was hospitalized—was this for physical or mental health care? If this was for mental healthcare, was this informal or under section?	Around 1 in 10 AE reports were unclear which meant it could not be clearly determined what had happened to participants. Improvement would be best achieved through training the whole study team in a standardized approach to adverse event monitoring. We discuss this in more detail elsewhere.23
Recommendation 4. Expanding upon Recommendation 3, Researchers should report whether the AE was related to study participation and provide sufficient detail for an independent observer to understand the context of the AE and the evidence for rating of relatedness.	From appraising the AE reports, it was clear that AEs could be related to many different parts of study participation. Reporting this in further detail will help determine research safety.