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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
Protocol and Information Office
Regulatory Affairs Branch
Administrative Resource Center
Last Updated:
01/22/09
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)
RECIST article published in JNCI
(PDF)
RECIST Quick Reference
(MS Word)
LOIs
/
Concepts
Letter of Intent (LOI)
LOI Submission Form
(MS Word.)
Career Development LOI Instructions
TRI 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)
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
CTEP, NCI Guidelines: Adverse Event Reporting Requirements
(PDF)
Adverse Event Expedited Reporting System (AdEERS)
CTCAE v2.0 and v3.0
CTCAE v3.0 and Lay Term Mapping Document - Cover Memo
(MS Word)
CTCAE v3.0 and Lay Term Mapping Document
(MS Excel)
AdEERS Single Agent Template
(PDF)
AdEERS Multiple Agent Template
(PDF)
CTC Generic Data Collection Form
(MS Word)
CTC Generic Data Collection Form
(PDF)
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)