Reference no: EM133538155

1. Training Record: This document is utilized to document that specific individuals have reviewed content, such as the protocol and procedures, with the investigator. The training record will include the investigator name, the protocol number, the date, and the monitor's name. Everyone included in the training will print and sign the form on the training record. This document will be kept on file and may be requested by the auditor during an inspection to verify the trial was conducted in accordance to the protocol. This document will help ensure compliance, minimize errors, standardize processes, and ensure data integrity is maintained.

2. Delegation of Authority Form This form is used by investigators or study coordinators to delegate study-related tasks to their staff members to perform on their behalf but they never relinquish responsibility for those tasks and their outcomes. The form contains information such as the name of the investigator, study protocol number, staff member information including name, signature, assigned roles, date, and role code. The delegation of authority form ensures a chronological delegation log and ensures that the individual performing the study-related tasks is assigned to do so.