CTSC DATA AND SAFETY AGREEMENT
Revised 7/30/2012
Consenting/Assenting: If this is a human subject study, the PI assures that the consent/assent process will be conducted
in accordance with the IRB approved protocol.
Data collection/study conduct: The PI assures that the actual conduct of the study, record keeping, data collection and
processing by research personnel will be monitored during the study.
Data sharing: The PI understands that the CTSC is NIH-funded and that research supported by the CTSC is subject to all
federal policies related to NIH-funded research. The PI affirms that s/he has read the NIH Data Sharing Policy:
http://grants.nih.gov/grants/policy/data_sharing/data_sharing_guidance.htm
as well as Weill Cornell Medical College’s Data Retention policy:
http://weill.cornell.edu/research/for_pol/forms/data_retention_policy_final.pdf
and that all research data resulting from this study will be retained and shared in accordance with these policies.
Resource sharing: If the current project involves the development or creation of unique research resources, including
software, with the help of CTSC resources, the PI agrees that future sharing of these resources will be in compliance with
current NIH resource sharing policies:
http://grants.nih.gov/grants/intell-property_64FR72090.pdf
Submission of publications to PubmedCentral: The PI has read the NIH’s Public Access Policy
(http://publicaccess.nih.gov/) and assures that all peer-reviewed journal articles resulting in whole or in part from work
supported by the CTSC will be submitted to PubmedCentral. The PI further agrees to acknowledge the CTSC grant (UL1
RR 024996) in all publications supported in whole or in part by the CTSC.
Research training: The PI affirms that all research personnel associated with the study have completed a valid Human
Subject Protection Training (CITI program or similar).
Adverse event reporting: The PI affirms that adverse events will be reported to all applicable IRBs, and other
appropriate entities.
I agree to adhere to the terms specified above:
Protocol Title:
Signature of PI:
Date:
After the Principal Investigator has signed this document, please scan and upload it to the “Supporting Documents”
page of your application in WebCAMP.