7.6 Recognition and Reporting of Adverse Events (AEs)

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The Designated Satellite Investigator (DSI) or delegate must ensure prompt recognition and reporting of Adverse Events (AEs) to the referring specialized childhood cancer program. The specialized childhood cancer program principal investigator (PI) holds the ultimate reporting responsibility to Children’s Oncology Group (COG) or other cooperative group study administrators, Ontario Cancer Research Ethics Board (OCREB) and Health Canada.

Description of AEs will be sent from the POGO Satellite Clinic program to the specialized childhood cancer program as part of the patient’s source documentation and will be reported to the study sponsor as per the protocol and to OCREB and Health Canada as per their requirements and the specialized childhood cancer program Standard Operating Procedures (SOPs).

For Severe Adverse Events (SAEs), the POGO Satellite Clinic must provide the information and all source documentation available to the specialized childhood cancer program within 24 hours of the event to ensure timely expedited reporting.

Disclaimer: Source Accuracy

You are welcome to download and save a local copy of this document in the Word and/or PDF formats provided. As the POGO Satellite Manual is subject to ongoing revisions and updates by POGO, we recommend you regularly check the online version posted at https://www.pogo.ca/satellite-manual/ to ensure you have the most up-to-date content. In the event of any inconsistency between the content of a local copy and the online version of the POGO Satellite Manual, the content of the online version shall be considered correct. Please see also the POGO Satellite Manual Disclaimer.

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