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(Click HERE for help.)

 
TABLE OF CONTENTS
Click a link below to jump to a particular section, or scroll down manually.  HELP: Key
The CCI forms available on this page exist in two formats.
This icon denotes documents in Microsoft Word format (DOC/DOT).  Use these forms for submission to the CCI.  NOTE: Some of these files include "hidden text" help messages to guide you through the form.  The "hidden text" messages will NOT print.  
This icon denotes documents in Adobe Acrobat format (PDF).  Do not submit these forms to the CCI. NOTE: help messages in PDF files WILL print. These files are for reference only. (PDF forms may be submitted if not available in Microsoft Word format.)  If you don't have Adobe Acrobat Reader, click here to download it.
NOTES:
  1. For in-depth instructions on how to download these forms, please see the various Instructional Documents below.
  2. If an icon is grayed out, the form is not available in that format.
  3. New and recently updated/posted forms have "Revised" dates highlighted in yellow.

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HELP: Instructional Documents
Use the various documents in the table below for help.
Download Document Purpose Revised

CCI Form Instructions A two page quick reference guide with clear instructions on how to use the various downloadable CCI Forms. 3/22/02

Forms "Read Me" Instructions on how use the various downloadable CCI forms. 2/27/02
Informed Consent Document Template Information Page Instructions on how determine which Informed Consent Document Template(s) to use, as well as instructions on customizing the templates for your protocol.  2/6/02


If, after using the resources above, you still need help, contact David in the CCI at (718) 430-2234 or via email.

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HELP: "Enter Network Password" Solution
Problem: An "Enter Network Password" pop-up dialog box (see below) appears when trying to view/download documents on the CCI website.

NOTE: The box is sometimes only visible on your Taskbar, and appears like this (circled in red):

In this case, click on it to open the dialog box, then follow the solution below.

Solution: A temporary solution is to simply click "Cancel."  Alternatively, you can download the "Office 2000 Service Release 1a (SR-1a)" patch for Microsoft Office 2000 that should fix the bug.  

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APPLICATIONS
These are the CCI research protocol applications, each specific to the type of research being conducted, please read the "Purpose" column below to determine which application is appropriate for your protocol.

Notice:

Effective immediately, all new protocol applications must be entered into the Protocol Application & Tracking System (PATS). In order to gain access to PATS, you and/or your staff responsible for submitting protocol transactions to the CCI must attend a PATS Training Session. 

Dates and times of upcoming PATS Training Sessions are listed on the PATS Information Page. 

Registration is required by completing the PATS Access Request Form.  Completed forms should be returned to Jacqueline (email: jasmith@aecom.yu.edu or fax: 718-430-8817). 

Thank you for your cooperation. 

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COPIES OF INDIVIDUAL FORMS IN THE APPLICATIONS
Occasionally, you may need duplicate copies of particular forms/pages found in the Protocol Applications listed above. Rather than having to download the entire application again, below we have provided you with separate copies of the individual forms.
Download Form Revised

Financial Conflict of Interest 3/25/02
Request for Waiver/Alteration or Exemption from HIPAA Authorization and Informed Consent 
NOTE: For more information on HIPAA, click here. 		6/19/03
Use of an Investigational Drug  
Drug Storage Waiver  
Investigational Use of Medical Device  
Use of Radioisotopes or Ionizing Radiation  
IND Exemption Request  
Assurances of the Principal Investigator Posted
12/19/05

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HIPAA FORMS
Click here for more information on HIPAA.  For a printable chart that explains what HIPAA forms are needed with new applications, click here.
Download Form Purpose Revised

English HIPAA Authorization Form Template for creating an English HIPAA Authorization Form to be signed by Research Participants. 11/05
English JMC/NCB HIPAA Authorization Form Template for creating an English HIPAA Authorization Form to be signed by JMC/NCB Research Participants. 11/05

Spanish HIPAA Authorization Form Template for creating a Spanish HIPAA Authorization Form to be signed by Research Participants. 11/05

Spanish JMC/NCB HIPAA Authorization Form Template for creating a Spanish HIPAA Authorization Form to be signed by JMC/NCB Research Participants. 12/15/03
English HIPAA Information Sheet Contains an explanation of the HIPAA Authorization Form in simple English, to be used with, but not in place of, the Authorization Form. 7/9/03
Spanish HIPAA Information Sheet Contains an explanation of the HIPAA Authorization Form in simple English, to be used with, but not in place of, the Authorization Form. 7/9/03
Request for Waiver/Alteration or Exemption from HIPAA Authorization and Informed Consent For requesting a Waiver/Alteration of Informed Consent and/or an Exemption/Waiver of HIPAA Authorization. 
(Replaces "Request for Oral Informed Consent & Oral HIPAA Authorization")		 9/26/03
Standard HIPAA Data Use Agreement For use when requesting a HIPAA Waiver for a Limited Data Set 2003
Posted 5/14/07

NOTE: For more information on HIPAA, click here.


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CONSENT DOCUMENTS TEMPLATES

Download Template Purpose Revised

 

 Informed Consent Note

 

 For documenting the Informed Consent Process in the study records. 11/16/05

 

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EMERGENCY USE
For more information on Emergency Use, see the Investigational Drug, Biologic and Device Policy, the Emergency Use of an Investigational Drug or Biologic Policy and Procedure, and the Emergency Use of an Investigational Device Policy and Procedure.
Download Template Revised
Request for Emergency Use of an Investigational Drug or Biologic 5/8/03
ICD Template for Emergency Use of an Investigational Drug or Biologic 5/8/03
Final Report for the Emergency use of an Investigational Drug or Biologic 5/8/03
Request for Emergency Use of an Investigational Device 5/8/03
ICD Template for Emergency Use of an Investigational Device 5/8/03
Final Report for the Emergency use of an Investigational Device 5/8/03

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OTHER FORMS
Download Form Purpose Revised
Reviewer Checklist for Full Review   4/5/07

Office of Biotechnology Request for Approval of an Outgoing MTA This form is required for the submission of any Material Transfer Agreements (MTAs) for human specimens to the Office of Biotechnology.  7/27/07

Office of Biotechnology Request for Approval of an Incoming MTA This form is required for the submission of any Material Transfer Agreements (MTAs) for human specimens to the Office of Biotechnology.  7/31/07

CCI Grant Application Form This form is required for ALL Researchers when bringing a Grant to the CCI. 9/29/04
HHC-641   1/93

Progress Report   9/3/03
Amendment   10/3/03
Advertisement To request approval of a new or revised advertisement. 10/30/07
Internal Adverse Event Report   6/9/05
External Adverse Event Report   1/6/04
Quality Assurance Guidelines & Templates To ensure that all researchers and their staffs have a consistent process that meets regulatory and institutional standards.  2/9/07
Report of FDA Notification For reporting to the CCI any communication received by the PI from the FDA.   
Patient Information Confidentiality Agreement   6/19/03
Sample Recruitment Letter to Potential Research Subjects    6/19/03
JMC/NCB Assurance Form  Required if the sole involvement of JMC or NCB is the recruitment of subjects for a protocol involving the General Clinical Research Center (GCRC). 2/12/01

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