Version 4.2.2

September 19, 2017

Human Subjects Application

A number of updates were made to address cellular therapy. Questions 7-2.4, 7-3.11, 14.1, 22.1, 22.2, 22.3, 22.4 and 22.7.

Note: updates to questions 7-2.4, 7-3.11 and 22.4 may require a different response than previously provided. Study teams should confirm response is still accurate.

IBC Application

For an initial application or an amendment, a notification will be generated for IBC staff, Environment, Health & Safety and the Export Control office when export controlled substances are selected.

Repository Application

Determination activities have been modified to allow for updates to the meeting history.