Canadian Cancer Trials Group Bulletins

Office of Compliance and Oversight

EDC SAEs and Concomitant Medications

As part of the process for submitting an initial SAE, the CRA from the site is to update the running log of concomitant medications with all medications the patient was receiving up until the time of SAE reporting and including those used to treat the SAE.

Further to the information provided at the Spring Meeting policy updates session, it has been confirmed that after the initial SAE reporting, additional concomitant medications that would not impact the SAE /change the evaluation of the SAE can just be added to the running Concomitant Medication running log and do not need to be repeated in the SAE report.

Any medication that could change the evaluation of the SAE should be added to the SAE report as a revision and the concomitant medication running log.

If you have any questions, please contact Bryn Fisher at the Safety Desk at 613-533-6430 or