Personnel roles and training
BLIND
We advise establishing clearly delineated roles among the research team, which may include treatment investigators, blinded evaluation investigators, research nurses, quality control officers, medication administrators, and documentation managers.The investigator responsible for efficacy evaluation remains blinded throughout the study, while all other personnel are unblinded. Staff roles should be defined and authorized prior to the trial (refer to Table List of responsibilities of principal investigators1. Receipt of medication into storage and maintenance;2. Distribution and recovery of drugs, medication compliance records.1. Requesting randomization and medication numbers for patients on the central randomization system;2. Prescribing.3. Wound clearing and dressing changes were performed on the subjects1. Pick-up medication;2. Assisting the treatment investigator with wound cleaning and medication change operations.1. Screening of subjects;2. Observation and evaluation of the efficacy index and safety index.1. Develop a quality control plan;2. Audit to maintain a blind state of operating procedures;3. Implement quality control according to the quality control plan.1. Preparation, organization, and filing of all documents;2. Manage and save files separately by blind and non-blind types.