Investigator:	     	Date:	     	
	Last name, first			
Project title:	     	

SEER-MEDICARE DATA USE AGREEMENT (DUA)
PRINCIPAL INVESTIGATOR

Information regarding persons with cancer is sensitive.  Therefore, specific laws have been enacted to insure the confidentiality of individuals included in cancer registry data.  In utilizing data on such individuals for research purposes, it is absolutely necessary to insure, to the extent possible, that uses of such data will be limited to research.  Uses for any other reason, particularly those resulting in personal disclosures, will be prosecuted to the full extent of the law.  In addition, release of information about the providers, i.e. the physicians and hospitals that provide care for cancer patients, may compromise the willingness of these providers to cooperate with the activities of the cancer registries.  Therefore, considerations regarding the privacy of providers are also of great importance.
 
In order for the National Cancer Institute to provide the linked SEER-Surveillance, Epidemiology and End Results (SEER)-Medicare data to you, it is necessary that you agree to the following provisions:

1.	You agree that the statements and methods made in your attached research proposal are complete and accurate.

2.	You will not use the data for purposes other than described in your research proposal. 

3.	You will not permit others to use the data except for collaborators within your institution involved with the research as described in your proposal.  Within your institution or organization, access to the SEER-Medicare data shall be limited to the minimum number of individuals necessary to achieve the purpose stated in your proposal. 

4.	You will establish and maintain the appropriate administrative, technical, and physical safeguards to protect the confidentiality of the data and to prevent unauthorized use or access to it, as described in your proposal.  

5.	You agree not to place the SEER-Medicare data on personal computers, portable devices and removable media unless these media are password protected AND encrypted.  Portable devices include any non-fixed equipment that contains an operating system which may be used to create, access or store SEER-Medicare data.  This includes but is not limited to laptops, personal digital assistants (PDAs), and smart phones. Removable media include, but are not limited to: CDs, DVDs, MP3 players, removable memory, and USB drives (thumb drives).  Approved encryption standards must be FIPS-140 compliant and include Advanced Encryption Algorithm (AES) that uses a 128, 192, or 256-bit key size. In the event that the data are lost or stolen, you agree to report the loss to the SEER-Medicare contact within 24-hours/first business day of discovering the loss. You may use an institutionally provided VPN to link to a time sharing system for data access.  The home based PC may support the VPN.  Any SEER-Medicare data taken off the time sharing system and placed on a home based computer must be password protected and encrypted as described above.

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6.	You must maintain all datasets containing restricted variables physically separate from any other SEER-Medicare files.  Separate access controls with strong user authentication (username/password, digital certifications, etc.) must be established to allow limited access to these files.  You should be able to track all access to these files

7.	All SEER-Medicare data must reside at your institution under your purview.  If you plan to move to a different institution, you must contact NCI in writing prior to moving for instructions on how to handle the SEER-Medicare data.  You may not duplicate any SEER-Medicare files prior to moving nor can you take SEER-Medicare data with you without written permission from NCI.  If you chose not to take the data with you, you must destroy the files or designate a new PI prior to moving. 

8.	You will not attempt to link nor permit others to link the SEER-Medicare data with individually identified records in another database without the written consent from the applicable SEER registries. .

9.	No one having access to the data will attempt to learn the identity of any persons with cancer in these data and/or their physicians or treating hospitals.  In the event that you discover or are able to deduce the identity of a specific patient or provider, you agree that you will not attempt to contact these individuals or institutions.

10.	No findings or information derived from the SEER-Medicare data may be released if such findings contain any combination of data elements that might allow the deduction of a patient’s or providers’ identity.  In tables, cell sizes less than 5 (five) must be suppressed. You agree that NCI shall be the sole judge as to whether any finding derived from the SEER-Medicare data would, with reasonable effort, permit one to identify an individual or provider, or to deduce the identity of an individual or provider to a reasonable degree of certainty.

11.	You agree to provide NCI with a copy of all manuscripts to be submitted for publication prior to submission.  You further agree not to submit such findings to any third party until receiving NCI’s approval to do so. NCI agrees to make a determination about approval and to notify the user within 4 weeks after receipt of any findings. NCI’s review of the findings is for the sole purpose of assuring that data confidentiality is maintained and that individual patients and/or providers cannot be identified. NCI may withhold approval for publication only if it determines that the format in which data are presented may result in identification of individual patients and/or providers.

12.	You agree that in the event NCI determines or has a reasonable belief that you have violated any terms of this agreement, NCI may request that you return the data and all derivative files to NCI.  You understand that as a result of NCI’s determination or reasonable belief that a violation of this agreement has taken place, NCI may refuse to release further SEER-Medicare data to you for a period of time to be determined by NCI.

13.	 All files received may be retained for a maximum of five years.  At the completion of the project or five years from receipt all files must be destroyed and notification of destruction must be sent to NCI.  Investigators who need to retain files beyond that period must contact NCI.

Please indicate the SEER-Medicare files you will use:

   	Patient Entitlement and Diagnosis Summary File) (PEDSF)	Years 	     	
   	Summarized Denominator File (SUMDENOM)	Years 	     	
   	MEDPAR	Years 	     	
   	Carrier (physician/supplier)	Years 	     	
   	Outpatient	Years 	     	
   	Home Health Agency	Years 	     	
   	Hospice	Years 	     	
   	Durable medical equipment	Years 	     	

These files will include:
   	Cancer cases	       	Non-cancer cases	

Signature of Principal Investigator (In the case of students and fellows, the department chair or advisor from the student's academic institution must sign the data request)

Your signature indicates that you agree to comply with the above stated provisions.  Deliberately making a false statement regarding any matter within the jurisdiction of any department or agency of the Federal Government violates 18 USC 1001 and is punishable by a fine up to $10,000 or up to five years in prison.

     	
Name – (printed or typed)	
     	
Institution/Organization	
     	
Street Address	
     	
City/State/ZIP code	
     		     	
Phone number – including Area Code	Fax number	
     	
Email address	

		     	
Signature	Date