12. Is the safety monitoring plan (suggested to be submitted as part of the CTA) part of the risk assessment?

Yes. The safety monitoring plan is the product of undertaking the risk assessment primarily concerning the risks of the IMP(s), as outlined in section A of the Appendix 2 of the risk-adaptive approach. As such, this would be part of the overall risk assessment and the information required to be submitted is a subset of the risk assessment process. The sponsor is encouraged to document the risk assessment such that it facilitates the extraction of this information ready for submission as the safety monitoring plan in the CTA (as a separate document, in the protocol or in the covering letter).
Version 1: 01 March 2012