What information should be included in the follow-up report?
For SAEs, the follow-up report should include details of the investigation, including a root cause analysis and details of any corrective or preventative measures identified. For SARs, the follow-up report should include details of the investigation, including confirmation of whether it was an SAR, clinical outcome, outcome of the investigation and final conclusions and any corrective and preventative measures identified. Examples of serious adverse events with explanations Positive microbial test result on stem cells detected at a tissue establishment post transplantation. No adverse reaction detected in the recipient.
