ETCTN Information Sheets and Checklists

ETCTN Guidelines

ETCTN Program Guidelines (updated July 5, 2016)

ETCTN Guidance on Study Activation

• Steps for Coordinating Centers to Open ETCTN Trials
• Steps for Participating Sites in ETCTN Trials

Information Sheets for Developing ETCTN Trials

• Steps for Developing an ETCTN Trial Concept from the Letter of Intent (LOI) to Study Activation
• Process for Incorporation of IROC Radiotherapy Services into ETCTN Studies
• Protocol Revision and Amendment Process
• NCI Central Institutional Review Board (CIRB) Initiative

Information Sheets for Conducting ETCTN Trials

• Cancer Trials Support Unit (CTSU)
• Person Registration and CTEP-Identity and Access Management (CTEP-IAM)
• Rosters and Roles for ETCTN Participants (Institution Rosters and Person Rosters)
• Patient Enrollment
• Data Management
• Agent Ordering
• Protocol Access and Communication
• Monitoring and Auditing
• Regulatory Processing
• Serious Adverse Event (SAE) Reporting