2.7.1. Clinical supervision
CRF
ADVERSE EVENT, CRF
An independent clinical research associate (CRA) shall be set up. The CRA shall formulate the supervision plan, list, and query list and conduct on-site supervision and visits to the clinical trial institutions regularly according to the enrollment progress, so as to ensure that all contents of the study protocol are strictly followed and the study data are filled in correctly and completely. The monitoring contents include the following: check and trace all trial data case-by-case, check the integrity, authenticity, and timeliness of case report form (CRF) data records, and track and verify the adverse event (AE) report; the factors and indicators that have an important impact on the test results (including inclusion criteria, exclusion criteria, implementation scheme, effectiveness evaluation index, safety evaluation index, and shedding rate) should be verified and confirmed on-site; each CRA monitoring should provide the corresponding monitoring records and reports and submit them to the researchers; and for the problems found in the inspection, a question form should be developed and submitted to the researcher for verification and confirmation before making changes.