Protocol Development

OEWG Implementation

Protocol Development

• NCI Standard Protocol Language for Collaborative Agreements (MS Word)
• Cooperative Group Common Budget Outline (MS Excel)
• Protocol Authoring Handbook (MS Word)
• Policies and Guidelines for Protocol Development
• Protocol Templates and Guidelines
• Protocol Submission Worksheet v4.5 (MS Word)
• Treatment Assignment Instructions and Guidelines (PDF)
• List of Codes and Values
  • Disease Codes
  • CTCAE 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) - Sites can voluntarily incorporate the new criteria and language into new protocols
  • 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)
  • The LOI Submission Form (MS Word) has been revised to emphasize CTEP's strong focus on molecularly-driven studies that incorporate suitable biomarkers and a "Team Science" approach. The revised form (version 3.0) is a bookmarked file available for download here.
  • Clinical Trial Design Phase 2 Recommendations (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)

• Grant Letter Requests
  • Grant Letter Request LOI (MS Word)
  • Procedure for Requests for Grant Letters for Drug Supply (MS Word)

• Concept Submission Form (MS Word)

Agents / Drugs

• Patient/Caregiver Ad Hoc Education Template
• CTEP Agents and Active Agreements (MS Excel)
• Policy and Guidelines for Investigational Agent Distribution (PDF)
• Policy and Guidelines for Investigational Agent Ordering (PDF)
  • Online Agent Order Processing (OAOP)
    • Register for an IAM Account (Required)
    • Submit OAOP Orders

• 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/Import/PRACTICEANDPOLICY/PracticeResourceCenters/ DrugShortages.aspx - ASHP web site for drug shortages. Information regarding shortages from American Society of Health Systems Pharmacists.
  • http://www.cdc.gov/vaccines/vac-gen/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 - Information for potential drug interactions with cytochrome P450 isoenzymes may be found at http://medicine.iupui.edu/flockhart/
• The Treatment Referral Center and Non-Research Use of Investigational Agents
• Non-Protocol Access to Experimental Agents

Adverse Events / AdEERS / CTCAE

• NCI Guidelines for Investigators: Adverse Event Reporting Requirements for DCTD (CTEP and CIP) and DCP INDs and IDEs (PDF)
• Pregnancy Report Form (PDF)
• Adverse Event Expedited Reporting System (AdEERS)
• Common Terminology Criteria for Adverse Events (CTCAE)
• Secondary Malignancies (including AML and MDS)
• Animated Presentation on AE Reporting and Final Rule 3-28-2011 (MS PowerPoint)
• Non-animated Presentation on AE Reporting and Final Rule 3-28-2011 (suitable for printing)
  (MS PowerPoint)

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 – Version date: February 15, 2013 (MS Word)

• Cover Letter from Dr. Jeffrey Abrams, February 15, 2013 (PDF)

• Letter to IRB Chairs and Members, February 15, 2013 (PDF)

• Phase-specific treatment trial consent form examples:

  • Phase 2 consent form example (MS Word)

  • Phase 3 consent form example (MS Word)

• Planning Committee Members (MS Word)

• Working Group Members (MS Word)

• CTEP Risk Presentation Working Group (MS Word)

• Tables of Possible Side Effects

  Note: The Tables of Possible Side Effects provided below are designed so they may be cut-and-pasted into the “What risks can I expect from taking part in this study?” section of the NCI Consent Form Template.

  • Tables of Possible Side Effects for Commonly-Used Oncology Drugs

  • Tables of Possible Side Effects for Commonly-Used Oncology Regimens (forthcoming)

  • Note: Tables of Possible Side Effects for CTEP IND agents will be made available directly to investigators by CTEP.

• Instructions for building Tables of Possible Side Effects:

  • Instructions for building Tables of Possible Side Effects for commercial agents (MS Word)

    • MICROMEDEX Scientific Terms - IC Term Spreadsheet 01-2013 (MS Excel)

  • Instructions for building Tables of Possible Side Effects for investigational agents (MS Word)

    • NCI Scientific Term CTCAE - IC Term Spreadsheet 02-2013 (MS Excel)

• Patient Confidential Disclosure Agreement (MS Word)

• Patient Confidential Disclosure Agreement (WordPerfect)

Ancillary / Correlatives

• Immunohistochemical (IHC) Marker Template For Integral Markers in CTEP Clinical Trials (PDF)
• DNA-Based In Situ Hybridization Biomarker Template (FISH, CISH) in CTEP Clinical Trials (PDF)
• 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)
• Amendment Request Submission Checklist (MS Word)