McClain, Don

Flanigan, Kevin
Kanner, Richard
Byington, Carrie
Aijoka, Richard

Cameron-Greene, Sandi
Palma, Deanna
Ahmed, Sayed
Suvannasankha, Kitiya
La Salle, Bernie
Holubkov, Rich
Jones, Laurene

GCRC Staff ______________________________

• Ensures that truly informed consent is obtained for all studies.
• Ensures that the patient/volunteer fully understands nature of study.
• Ensures that any serious adverse events or potential conflicts of interest are reported to the GCRC Advisory Committee, the IRB and the appropriate federal agencies.
• Serves as a regular member of the GCRC Advisory Committee.
• Meets with investigators at the time of their application to discuss guidelines for data safety and monitoring.
• Serves as an ad hoc member of IRB and attend all meetings in which GCRC sponsored studies are discussed.
• Develops an ongoing "In Service" program for the research nursing staff and implements this program for every protocol approved by the IRB.
• Serves as an unbiased observer, when requested, during the obtaining of informed consent.
• Develops an information packet for each high-risk protocol, in addition to the information packages prepared by individual investigators.
• Supplies minutes documenting that each protocol has a review addressing data safety and monitoring issues upon request of site visitors or NCRR staff.
• Develops a series of seminars that GCRC investigators will be required to attend to keep them informed and appropriately trained on carrying out required regulatory and patient safety responsibilities.

 

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