Investigator Responsibilities for Research. Jan Zolkower, MSHL, CIP, CCRP January 13, 2012. Agenda. Review Investigator Responsibilities Discuss recent FDA Warning letters and OHRP Determination letters Review of Advanced Notice of Proposed Rulemaking (ANPRM) Q & A. PI Responsibilities.
Investigator Responsibilities for Research
Jan Zolkower, MSHL, CIP, CCRP
January 13, 2012
In other words…EVERYTHING!
L. Diaz, MD, Infectious Disease Associates of the Palm Beaches – November 4, 2011
1) Failure to conduct or adequately supervise the clinical investigations
2) Failure to ensure that the investigation was conducted according to the investigational plan
3) Failure to return the unused supplies of the drug to the sponsor, or otherwise provide for disposition of the unused supplies of the drug
The PI’s written affidavit stated:
The warning letter notes:
The FDA letter included the following statement:
“Failure to adequately and promptly explain the violations noted above may result in regulatory action without further notice."
M. Thurmond-Anderle, MD – February 25, 2011
Failed to conduct the studies or ensure they were conducted according to the investigational plan, and to protect the rights, safety, and welfare of subjects.
The protocol required a pharmacist or appropriately qualified person prepare and provide the infusion bags containing the study medication or placebo.
Our investigation revealed that your office manager, who is not a pharmacist and does not appear to be appropriately qualified to prepare infusion bags, inaccurately prepared the study drug or placebo for infusion at approximately one-tenth of the protocol-specified dose.
September 29, 2010
L. Snow, MD
August 12, 2011
Yale Cohen, MD
The PI was previously cited for items 1 and 2 in 2008/2009.
treatment for research related injury
was initially provided information about the study;
was given a copy of the consent form;
was contacted to determine interest; and
signed the document.
October 10, 2010
H. Lippton, MD
Advance Notice of Proposed Rulemaking (ANPRM)
Being the PI of a research study is a huge undertaking that requires attention to detail and a tremendous amount of communication with the study team, participants, the IRB, as well as other departments and agencies.
Thank you for everything you do to ensure the rights, welfare and safety of the research participants we serve are protected.