With regard to the point about SAE reporting of Screen Failures (SF) you might be interested in the EU Volume 10 document on Q & As. --- "7.31 Question: When do requirements to record and report safety issues start and end for the investigator and the sponsor? 338. AEs, including SAEs, should be recorded by the sponsor and the investigator from the signature of informed consent to the end of the trial unless otherwise provided for in the protocol".