Guidelines and Tools for Protocol Development

Investigators' Handbook Letter of Intent (LOI) LOI Submission Form (MS Word Doc.) Career Development LOI Instructions TRF Cost Estimate Worksheet (MS Excel) Components of a Competitive Letter of Intent (MS Word) Recent Solicitations for letters of intent for investigational agents available through CTEP (MS Word) Investigational Drug Steering Committee (IDSC) Concept Submission Concept Submission Form (MS Word) CTEP Review Types CTEP's Review Types and Decision Tree (MS Word) List of Codes and Values MedDRA Codes Agent NSC Numbers Country Codes Cooperative Group Codes Institution Codes Specimen collection guidelines for breast cancer Group trials Slow Accrual Guidelines for Phase III Trials Slow Accrual Guidelines Development Artifacts

Protocol Templates and Applications Cytochrome P450 Drug Interaction Tables Protocol Authoring Handbook Phase I and II Templates Phase III Template Organ Dysfunction Templates Protocol Submission Worksheet Response Evaluation Criteria in Solid Tumors (RECIST) Common Data Elements CTCAE (formerly known as CTC) v2.0 and v3.0 Adverse Event Guidelines Informed Consent Guidelines CTEP Amendment Requests Treatment Assignment Instructions and Guidelines NCI Standard Protocol Language for Collaborative Agreements (MS Word) Patient Confidential Disclosure Agreement (WordPerfect) Patient Confidential Disclosure Agreement (MS Word) Non-Protocol Access to Experimental Agents (MS Word) Correlative Science Guidelines (MS Word) Tier System Ancillary Studies (PDF) Cooperative Group Common Budget Outline (MS Excel) CTEP Conflict of Interest Policy for Cooperative Group Phase 3 Trials (PDF) NCI Clinical Trials Cooperative Group Program Data Sharing Policy Data Sharing Policy Document (MS Word) Data Sharing Policy Document (PDF) NCI Clinical Trials Cooperative Group Program Guidelines for Development, Conduct and Analysis of Clinical Trials with International Collaborating Institutions (PDF)

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