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1.28 External Investigator Assurance
1.0 Purpose The purpose of this policy is to describe the Organization’s requirements for initia...
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...
1.19 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...
3.10 Pregnancy Testing
1.0 Purpose The purpose of this policy and procedure is to describe the Organization’s requireme...
3.9 Contraception Requirements
1.0 Purpose The purpose of this policy and procedure is to describe the contraception requiremen...
3.7 Finder’s Fees and Recruitment Bonuses
1.0 Purpose The purpose of this policy and procedure is to describe the Organization’s requireme...
3.1 Assessing the Need for Increased Monitoring, Interim Continuing Review, and Verification from Sources Other than the PI
1.0 Purpose The purpose of this policy and procedure is to describe the Organization’s requireme...
5.6 Exceptions from Informed Consent Requirements for Emergency Research
1.0 Purpose The purpose of this policy and procedure is to describe the Organization’s requireme...
6.3 Humanitarian Use Device (HUD)
1.0 Purpose The purpose of this policy and procedure is to describe the Organization’s requireme...