Irb investigator manual






















This document “Investigator Manual” is designed to guide and inform an investigator of required policies and procedures related to the conduct of Human . LOGO Investigator Manual NUMBER DATE PAGE HRP 5/09/ 5 of 52 Worksheets: Worksheets are documents that the Human Research Review Committees (HRRCs) use to make determinations. These are guidance documents that are not always. •Updated various hyperlinks • Expanded guidance in Sponsor/CRO/Site Translations section • Expanded Outcome Documentation section • Add the following the Site Reporting section “As a reminder, it is the Principal Investigator's responsibility to ensure a current medical license, if applicable, is on file with the IRB” • Added instructions regarding submi ssions that relate to.


with Institutional Policies and Procedures and the Investigator Manual (HRP). The IRB may, at its discretion, require a faculty member to function as PI, with a student, resident or other trainee functioning in a co-investigator role. This decision will be made on a case-by-case basis. IRB Metrics. eIRB Implementation October Getting started. Investigator Manual. Policies SOPs Checklists/Worksheets. Policies SOPs Checklists/Worksheets. Forms and Templates. Reliance Agreements. General Information. This Investigator Manual is designed to guide investigators and study staff through policies and procedures related to the conduct of Human Research that are specific to the Harvard Longwood Campus (HLC) Human Research Protection Program (HRPP), which serves the Harvard.


An Institutional Review Board (IRB) is a committee designated by an institution to review, approve, and conduct periodic post-approval review of Human Research. 21 thg 1, The UTEP IRB has the sole authority to determine whether an activity meets the definition of. “Human Subject Research” by considering. The HRPP encompasses the IRB, the Institutional Official (IO), the. Research Integrity team of the Office of Research Administration, the Vice Provost for.

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