Section 3: Special Issues

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...

3.2 Data and Safety Monitoring

1.0 Purpose The purpose of this policy is to describe the Organization’s requirements for data a...

3.3 Privacy Interests and Confidentiality of Research Data

1.0 Purpose The purpose of this policy and procedure is to describe the Organization’s requireme...

3.4 Use of Protected Health Information in Research

1.0 Purpose The purpose of this policy and procedure is to describe the Organization’s requireme...

3.5 Subject Recruitment Through Advertisements

1.0 Purpose The purpose of this policy and procedure is to describe the Organization’s requireme...

3.6 Subject Recruitment Through Direct Invitation

1.0 Purpose The purpose of this policy is to describe the Organization’s requirements for subjec...

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...

3.8 Research Subject Compensation and Reimbursement

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...

3.10 Pregnancy Testing

1.0 Purpose The purpose of this policy and procedure is to describe the Organization’s requireme...

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...

3.12 Ethical Access

1.0 Purpose The purpose of this policy is to define ethical access and to describe the Organizat...

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...

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