Protocol Development

Protocol Development Helps

• NCI Standard Protocol Language for Collaborative Agreements (MS Word)
• Cooperative Group Common Budget Outline (MS Excel)
• Protocol Authoring Handbook (MS Word) (Updated June 6, 2007)
• Policies and Guidelines for Protocol Development
• Protocol Templates and Guidelines
• Protocol Submission Worksheet v4.4 (MS Word)
• Protocol Submission Worksheet v4.4 (PDF)
• Trial Complexity Elements and Scoring Model (MS Word)
• Educational Slides for Scoring Trial Complexity (MS PowerPoint)

• Treatment Assignment Instructions and Guidelines (PDF)
• List of Codes and Values
  • Disease Codes
  • CTC v2.0/CTCAE v3.0 Codes
  • Pre-Existing Condition Codes
  • Therapy Codes
  • Agent NSC Numbers
  • Country Codes
  • Cooperative Group Codes
  • Institution Codes

• Suggested Templates for Phase 1 and 2 Clinical Trials
• Response Evaluation Criteria in Solid Tumors (RECIST)
  • Revised RECIST Guideline (version 1.1) (PDF)
  • RECIST - Measurement of Effect Criteria (includes language for inclusion in CTEP protocols) (MS Word)
  • RECIST Article Published in EJC (PDF)
  • RECIST Article Published in JNCI (PDF)

LOIs / Concepts

• Letter of Intent (LOI)
  • LOI Submission Form (MS Word.)
  • Career Development LOI Instructions
  • Components of a Competitive Letter of Intent (MS Word)
  • Recent Solicitations for letters of intent for investigational agents available through CTEP (MS Word)

• Concept Submission Form (MS Word)

Agents / Drugs

• CTEP Agents and Active Agreements (MS Excel)
• Policy and Guidelines for Investigational Agent Distribution (PDF)
• Policy and Guidelines for Investigational Agent Ordering (PDF)
  • Clinical Drug Request (NIH - 986) form (PDF)

• Policy and Guidelines for Accountability and Storage of Investigational Agents (PDF)
  • NCI Investigational Drug Accountability Form (PDF)

• Policy and Guidelines for Transfer of DCTD-Supplied Investigational Agents (PDF)
  • NCI Transfer Investigational Agent Form (PDF)

• Policy and Guidelines for Investigational Agent Returns (PDF)
  • NCI Return Investigational Agent Form (PDF)

• Links to Commercial Drug Shortage Resources
  • http://www.fda.gov/medwatch - to enroll in Medwatch and receive e-mails when shortages are identified by FDA
  • http://www.fda.gov/cder/drug/shortages/ - FDA Web site for drug shortages. Provides most current information from FDA
  • http://www.ashp.org/shortage/index.cfm?cfid=4794203&CFToken=14453158 - ASHP web site for drug shortages. Information regarding shortages from American Society of Health Systems Pharmacists.
  • http://www.cdc.gov/nip/news/shortages/default.htm - CDC website for Vaccine shortages
  • http://www.pharmacyonesource.com - Pharmacy One Source (Free Subscription), provides MEDWATCH and other information

• Cytochrome P450 Drug Interaction Tables - Only major substrates and effective inducers are listed. Additional information for drug interactions with cytochrome P450 isoenzymes may be found at http://medicine.iupui.edu/flockhart/
  • CYP3A4 (MS Word)
  • CYP1A2 (MS Word)
  • CYP2A6 (MS Word)
  • CYP2B6 (MS Word)
  • CYP2C8/9 (MS Word)
  • CYP2C19 (MS Word)
  • CYP2D6 (MS Word)
  • CYP2E1 (MS Word)

• The Treatment Referral Center and Non-Research Use of Investigational Agents
• Non-Protocol Access to Experimental Agents

Adverse Events / AdEERS / CTCAE

• CTEP, NCI Guidelines: Adverse Event Reporting Requirements (PDF)
• Adverse Event Expedited Reporting System (AdEERS)
• Common Terminology Criteria for Adverse Events (CTCAE)
• NCI Secondary AML/MDS Form (PDF)

CDE / Data policies / CDUS

• Common Data Elements (CDE) Dictionary (MS Word)
• NCI Clinical Trials Cooperative Group Program Data Sharing Policy (MS Word)
• NCI Clinical Trials Cooperative Group Program Data Sharing Policy (PDF)
• Data and Safety Monitoring (DSM) Plans
• NCI Cooperative Group Data Monitoring Committee Policy (MS Word)
• ARTICLE: Role of Independent Data-Monitoring Committees in Randomized Clinical Trials Sponsored by the National Cancer Institute (PDF) JCO, Vol 15, No 7 (July), 1997: pp 2736-2743
• Slow Accrual Guidelines for Phase 3 Trials (PDF)
• Development of Slow Accrual Guidelines (PDF)
• Clinical Data Update System (CDUS)

Informed Consent

• NCI Informed Consent Template (MS Word)
• Template as Posted on Simplification of Informed Consent Documents
• Letter from Dr. Michaele Christian describing changes to the NCI Informed Consent Template (MS Word)
• Patient Confidential Disclosure Agreement (MS Word)
• Patient Confidential Disclosure Agreement (WordPerfect)

Ancillary / Correlatives

• Correlative Science Guidelines (MS Word)
• Tier System Ancillary Studies (PDF)
• Specimen Collection Guidelines for Breast Cancer Group Trials
• CTEP Pharmacogenomics Guidelines (MS Word)

Monitoring

• Guidelines for Monitoring of Clinical Trials for Cooperative Groups, CCOP Research Bases, and the Cancer Trials Support Unit (CTSU)

Amendments

• Protocol Status Update (MS Word)
• CTEP Amendment Request Submission Policy (PDF) (Updated May 14, 2004)
• Amendment Request Submission Checklist (MS Word)