Project Management plans include a communication plan, escalation, risk management, study initiation to close out activities, and timelines

Regular internal or external study meetings with sponsor and internal teams Development of Trial Master File (TMF) and Investigator Site files

Quality Control Plans include a procedure to escalate significant GCP non-compliance and regulatory inspections

Trial Status Reports (TSR)

Study Progress Reports

Submission of study reports to regulatory authority (e.g. CHMP), if needed