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U.S. National Institutes of Health
Last Updated: 11/06/12

CTEP Forms, Templates and Documents

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Investigator Registration (1572) Form

Form Title Adobe Acrobat (.pdf) MS Word (.doc) WordPerfect (.wpd)
FDA Form 1572 for Investigator Registration [Download FDA 1572 Form]    
Supplemental Form for Investigator Registration [Download Supplemental Form]    
Financial Disclosure Form for Investigator Registration [Download Financial Disclosure Form]    

Protocol Development and Assembly

Form Title Adobe Acrobat (.pdf) MS Word (.doc) WordPerfect (.wpd) Excel (.xls)
Letter of Intent (LOI) Submission Form v2.0   [Download LOI Form]    
Career Development LOI Instructions   [Download LOI Instructions]    
Cost Estimate Worksheet       [Download LOI Form]
Concept Submission Form   [Download Concept Submission Form]    
Protocol Templates:        
AE Templates:        
     AE Template Phase I Single Agent v1.1   [Download Phase I Single Agent Form]    
     AE Template Phase I Combination v1.1   [Download Phase I Combination Form]    
     AE Template Phase II Single Agent v1.1   [Download Phase II Single Agent Form]    
     AE Template Phase II Combination v1.1   [Download Phase II Combination Form]    
NCI Informed Consent Templates   [Download NCIIC Form]    
CTCAE v3.0 and Lay Term Mapping Document   [Download NCIIC Form]   [Download NCIIC Form]
Protocol Submission Worksheet v4.5 [Download Form]    
CTC Generic Data Collection Form [Download  Form] [Download  Form]    
Protocol Status Update   [Download Protocol Status Update Form]    
Amendment Request Submission Checklist   [Download Amendment Request Submission Checklist]    
Correlative Science Guidelines   [Download Form]    

Requisition of Agents

Form Title Adobe Acrobat (.pdf) MS Word (.doc) WordPerfect (.wpd)
NCI Investigational Drug Accountability Record Form [Download NCI Investigational Drug Accountability Record form]    
NCI Transfer Investigational Agent Form [Download NCI Transfer Investigational Agent Form]    
NCI Return Investigational Agent Form [Download NCI Return Investigational Agent Form]    

Reporting Forms

Form Title Adobe Acrobat (.pdf) MS Word (.doc) WordPerfect (.wpd)
AdEERS Single Agent Template [Download FDA Form 3500]    
AdEERS Multiple Agent Template [Download FDA Form 3500]    

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