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Protocol Development
CTEP Home
CTEP Branches
and Offices
Office of the
Associate Director
Clinical Grants and Contracts Branch
Clinical Investigations Branch
Clinical Trials Monitoring Branch
Investigational
Drug Branch
Pharmaceutical Management Branch
Operations and Informatics Branch
Regulatory Affairs Branch
Administrative Resource Center
Last Updated:
12/11/12
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)
LOI Submission Form
(MS Word)
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
(MS Word)
Template as Posted on Simplification of Informed Consent Documents
Letter from Dr.Jeffrey Abrams describing changes to the NCI Informed Consent Template
(MS Word)
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)