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Hello, does a company have obligation to submit 6 monthly SUSAR LL to EudraCT even if EU studies completed but other regions non-EU still ongoing ? Thank you, your timely response would be appreciated with a reference to cross check if possible
The views below are of the PIPA committee and do not represent any particular company.
According to The rules governing medicinal products in the European Union VOLUME 10 – Guidance documents applying to clinical trials
CLINICAL TRIALS REGULATION (EU) NO 536/2014 DRAFT
QUESTIONS & ANSWERS
VERSION 4.17.31 Question: When do requirements to record and report safety issues start and end for the investigator and the sponsor?
337. 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.Therefore our interpretation would be for reporting to continue until the trial has concluded.
However, in practice it would be recommended to communicate with the specific authority as to whether a line listings is required and for how long as the expectation may differ between countries.
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