(AAAR) Application Access Authorization Request: Form used to request access to multicenter trial management applications such as, Specimen Manager, integrated information management system (IIMS), electronic document management system (EDMS) etc. for all applicable staff members at participating sites.

 

Delegation of Authority Log (DOA):  Comprehensive list of study staff members and the duties that have been delegated to them by the PI.

 

Ethics  Committee:  An independent group of both medical and non-medical professionals who are responsible for verifying the integrity of a study and ensuring safety, integrity, and human rights of the  study participants.

 

(FWA) Federal Wide Assurance:  An agreement between a research institution and the Department of Health and Human Services (DHHS) to comply with federal regulations concerning research involving human subjects, including the ethical principles outlined in the Belmont Report and the DHHS regulations 45 CFR Part 46. The FWA is the only type of assurance currently accepted and approved by the Office for Human Research Protections (OHRP).

 

Lead Investigator: A Lead Investigator is one who oversees the operations and conduct of the study at the lead site and is responsible for coordination, management, reporting, and regulatory requirements between multiple sites. (IRB3 Approved 9/26/12)

 

Lead Site: A Lead Site is one that initiates or manages (agrees to be responsible for) a research study involving multiple sites that conduct research procedures for the study. A Lead Site would be responsible for the overall regulatory conduct of the study, including assuring that an appropriate approved monitoring plan is in place to oversee the study at all sites and is also responsible for reporting deficiencies to regulatory agencies. (IRB3 Approved 9/26/12)