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Section 3: Special Issues

3.1 Assessing the Need for Increased Monitoring, Interim Continuing Review, and Verification from Sources Other than the PI

Last Revised: 1/2/2018 1.0 Purpose The purpose of this policy and procedure is to describe the Or...

3.2 Data and Safety Monitoring

Last Revised 12/22/2022 1.0 Purpose The purpose of this policy is to describe the Organization’s ...

3.3 Privacy Interests and Confidentiality of Research Data

Last Revised 1/21/2024 1.0 Purpose The purpose of this policy is to describe the Organization’s r...

3.4 Use of Protected Health Information in Research

Last Revised: 4/9/2018 1.0 Purpose The purpose of this policy and procedure is to describe the Or...

3.5 Subject Recruitment Through Advertisements

Last Revised 12/11/2024 1.0 Purpose The purpose of this policy is to describe the Organization’s ...

3.6 Subject Recruitment Through Direct Invitation

Last Revised: 3/12/2025 1.0 Purpose The purpose of this policy is to describe the Organization’s ...

3.7 Finder’s Fees and Recruitment Bonuses

Last Revised: 1/26/2018 1.0 Purpose The purpose of this policy and procedure is to describe the O...

3.8 Research Subject Compensation and Reimbursement

Last Revised: 7/3/2024 1.0 Purpose The purpose of this policy is to describe the Organization’s r...

3.9 Contraception Requirements

Last Revised: 11/21/2017 1.0 Purpose The purpose of this policy and procedure is to describe the ...

3.10 Pregnancy Testing

Last Revised: 1/8/2018 1.0 Purpose The purpose of this policy and procedure is to describe the Or...

3.11 Collecting Data from Pregnant Partners of Research Subjects

Last Revised: 9/9/2019 1.0 Purpose The purpose of this policy is to describe the Organization’s r...

3.12 Ethical Access

Last Revised: 3/5/2025 1.0 Purpose The purpose of this policy is to define ethical access and to ...

3.13 Use of Placebo or Wash-Out of Effective Therapy in Clinical Trials

Last Revised: 2/7/2018 1.0 Purpose The purpose of this policy and procedure is to describe the Or...

3.14 Phase I and First-in-Human Studies

Last Revised: 2/5/2018 1.0 Purpose The purpose of this policy and procedure is to describe the Or...

3.15 Managing Radiographic Incidental Findings in Human Subjects Research

Last Revised: 2/28/2018 1.0 Purpose The purpose of this policy and procedure is to describe the O...