Selection of reporting Member State
For a national clinical trial, the reporting Member State (rMS) is the MS to which the clinical trial application is submitted. For multinational trials, the sponsor proposes a rMS but it is up to the MSc to express their willingness to become rMS during the first 3 days of the application.
Between day 3 and 6 the selection of the rMS takes place among the MSc willing to be rMS. If more than one MSc is willing, the MSc with the lowest workshare proposes a candidate rMS (from the pool of willing MS). The workshare is primarily based on an algorithm of work sharing taking into account the number of multinational clinical trials where the MS acts as a rMS and the total number of multinational clinical trials where the MS participates. If no MSc is willing to be rMS, the MS proposed by the sponsor will be the rMS or may propose another MS to be rMS. See also CTIS training module 6 Selection of reporting Member State (RMS) and validation of the clinical trial application.
The CTR does not provide for a procedure to change the rMS. However, it may be possible for a rMS to delegate/contract out the work to another MSc, but the responsibility will still lie with the original rMS.