Extract to table

In the event of any perceived inconsistency between these Safety Reporting Procedures and the Protocol, the Protocol shall govern unless applicable law or regulation requires otherwise

Section 2: Definitions For purposes of these Safety Reporting Procedures, the following terms shall have the meanings set forth below

Capitalized terms not defined in this Section 2 shall have the meanings ascribed to them in the MCTA or, if not defined therein, in Protocol PPC-4871-III

For the avoidance of doubt, medically necessary protocol deviations implemented by the investigator to protect the immediate safety of a subject are permitted and must be documented and reported promptly to the Sponsor, Meridian CRO, and the applicable IRB, as further described in Section 9 of the MCTA

In the event that the investigator determines that an immediate deviation from the Protocol is necessary to protect the safety of a subject, the investigator must implement such deviation and promptly report it to the Sponsor, Meridian CRO, and the applicable IRB, documenting the circumstances and the actions taken

1 Adverse Event Reporting (Non-Serious) All adverse events, whether or not considered by the investigator to be related to the investigational product (penterafenib) or placebo, must be identified, assessed, and recorded by the site investigator or designee