To be able to run a clinical trial involving an AT(I)MP or GM(O) within NHS Lothian, review and approval should be sought from the Advanced Therapy and Gene Modification Safety Committee (ATGMSC). This approval is required before NHS Lothian R&D Management approval will be granted.

Applications are reviewed using a dedicated Risk Assessment document submitted by the Principal Investigator. Form A should be used for clinical trials involving GM(O)products and Form B for clinical trials involving AT(I)MPs.