With reference to ICH E6, the Sponsor should have the (original) CRFs (8.3.14) and corrections (8.3.15) in the TMF . How are Sponsors meeting this requirement when working with Phase 1 units using early phase EDC? Often these EDC systems have non-CRF source data, CRF and data queries in the same system and difficulty providing a recognisable CRF and record of CRF changes for the Sponsor at the end of trial.