Reliance Agreements Irb

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Individual Investigator Agreement (Contact to request the form) In addition, penn IRB has adhered to both the Smart IRB and IRB Choice-Joinder agreements and can enter into trust agreements with other academic centers that have also adhered to one of the two agreements. For the IRB pen to be the revising IRB, the examiner must first be submitted to the Penn IRB (including the completed Penn-CHOP destination form signed by the examiner). If the IRB pen agrees to be the control IRB and signs the destination form, the CHOP PI must submit the study and destination form (now signed by the control physician and the IRB pen) to the CHOP IRB as a “CHOP-dependent research study to an external IRB”. This is a usage abbreviated to eIRB. As soon as chop agrees to transfer the verification to penn IRB, an IRB president or delegate signs the destination form. For more information, see the section “If CHOP is asked to hand over supervision to an external IRB: What should be done?” below. If the JHSPH IRB accepts the trust agreement and provides a support letter of support, you must ensure, as an IP, that all responsibilities are fulfilled in the form of Investment Insurance. They must ensure that study personnel receive adequate training and are qualified to perform their duties and that the study is conducted in accordance with the approved protocol and JHSPH guidelines. You must inform the JHSPH IRB of any changes to the study that may affect the specific requirements of the site, for example.B. Conflict of interest, study staff, funding flow, clinical procedures (could affect the analysis of the PRA), modification of the study drug (impact on local verification of pharmacy & Therapeutics), etc. The first step in the trust agreement process is to enter into a trust requirement. The JHM IRB Reliance team will verify the information provided in the Reliance Request survey and contact you with the next steps/instructions.

The UNC profile contains background information about the UNC IRB and institutional processes and requirements when trust agreements with cooperating sites are considered or negotiated. . . .

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