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Developing a Budget
Considerations for Preparing a Budget For studies that require a grant or contract, the Investig...
4.2 Research Involving Pregnant Women, Human Fetuses, and Neonates (Nonviable or of Uncertain Viability)
1.0 Purpose The purpose of this policy is to describe the Organization’s requirements for IRB re...
4.6 IRB Review of Research Involving Subjects with Impaired Decision-Making Capacity
1.0 Purpose The purpose of this policy is to describe the Organization’s requirements for IRB re...
3.2 Data and Safety Monitoring
1.0 Purpose The purpose of this policy is to describe the Organization’s requirements for data a...
1.28 External Investigator Assurance
1.0 Purpose The purpose of this policy is to describe the Organization’s requirements for initia...
1.7 IRB Member, Consultant, Staff and Guest Conflict of Interest Identification and Management
1.0 Purpose The purpose of this policy is to describe the Organization’s requirements for the id...
4.4 Research Involving Children
1.0 Purpose The purpose of this policy is to describe the Organization’s requirements for resea...
5.5 Use of the Short Form Consent Document
1.0 Purpose The purpose of this policy is to describe the Organization’s requirements for use of...
1.18 Review and Approval of HRPP Policies and Procedures
1.0 Purpose The purpose of this policy is to describe the Organization’s requirements for the re...
1.19 IRB Signature Authority
1.0 Purpose The purpose of this policy is to describe the Organization’s requirements for granti...
1.32 Confidentiality of the Review Process
1.0 Purpose The purpose of this policy and procedure is to describe the Organization’s requireme...
1.31 Observers at IRB Meetings
1.0 Purpose The purpose of this policy and procedure is to describe the Organization’s requireme...
1.27 Research Personnel Qualifications and Responsibilities
1.0 Purpose The purpose of this policy and procedure is to describe the qualifications and respo...
1.13 Compliance with ICH-GCP Guidelines
1.0 Purpose The purpose of this policy and procedure is to describe the Organization’s requireme...
2.5 Criteria for IRB Approval
1.0 Purpose The purpose of this policy and procedure is to describe the Organization’s criteria ...
3.13 Use of Placebo or Wash-Out of Effective Therapy in Clinical Trials
1.0 Purpose The purpose of this policy and procedure is to describe the Organization’s requireme...
3.14 Phase I and First-in-Human Studies
1.0 Purpose The purpose of this policy and procedure is to describe the Organization’s requireme...
3.15 Managing Radiographic Incidental Findings in Human Subjects Research
1.0 Purpose The purpose of this policy and procedure is to describe the Organization’s requireme...
3.12 Ethical Access
1.0 Purpose The purpose of this policy is to define ethical access and to describe the Organizat...
3.11 Collecting Data from Pregnant Partners of Research Subjects
1.0 Purpose The purpose of this policy is to describe the Organization’s requirements for obtain...