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...