Here are some of our experience-based tips:
Be familiar with the regulations and protocol guidelines that apply to the studies you are responsible for. Inspectors are looking to confirm that you are complying with the applicable regulations and study procedures.
Know the scope of your responsibilities and know which members of the team are responsible for specified study activities.
Be familiar with not only the regulatory definitions of Serious Adverse Events/Adverse Events and the required actions, but also protocol specific definitions. Be sure you are complying with requirements of the regulations and the protocol.
Keep your study files in a ‘ready state’ at all times.
Periodically review study materials for accuracy and completeness. Pay particular attention to items that may be required to be updated during the course of a study such as the Delegation of Authority log, study team licenses, training and CVs. Remember, keep all versions of documents throughout the course of the study. Do not discard outdated documents.
Share what you learn and your experience with others.
