Attestation Forms:
Change in Process for Sub-Investigators
The process for Sub-Investigator attestation forms will be updated on Friday, May 8th.
What is changing?
New Sub-Investigator attestation forms after May 8th will be completed outside of iRIS.
The attestation will be added to the current Outside Interest Log and will be available on the DF/HCC website.
If the sub-investigator has a conflict to report, the Outside Interest Log will need to be submitted to OHRS via Administrative Modification in iRIS. If there is no conflict reported, the form can be filed in the regulatory binder and does not need to be submitted to OHRS.
Previous attestation forms initiated prior to May 8th in iRIS should still be completed by the Sub-Investigator.
What remains the same?
New Project Applications will still be routed to the applicable PI(s) for sign off.
Reminder: If any PI has a conflict of interest at the start of the study, the Core Site must submit the Outside Interest Log as an Administrative Modification in iRIS.
Add Site or Change in PI Amendment processes remain the same. The Core study team will still be responsible for sending the new PI an attestation form in iRIS.
REMINDER:If any investigator has a conflict of interest that needs to be reported, an Administrative Modification must be submitted with the Outside Interest Disclosure Log.
Thank you for your attention to these upcoming changes and for all that you have done and will do to maintain clinical trial operations during these uncertain times.
Sincerely,
Drew Memmott
Senior Vice President for Cancer Center Administration, Dana-Farber Cancer Institute
Associate Director for Administration, Dana-Farber/Harvard Cancer Center
Farah Daftary
Vice President for Clinical Trials Operations, Dana-Farber/Harvard Cancer Center and Dana-Farber Cancer Institute
Erica Woulf
Senior Director, Research Informatics Operations, Dana-Farber/Harvard Cancer Center and Dana-Farber Cancer Institute
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