A- General Policies:

• 1. Educational Requirements for the Protection of Human Subjects.
• 2. Swedish Research Center Staff Participation In Research.
• 3. Publication of Research Results.
• 4. Research Misconduct.

  B- Information Systems:

• 1. Site-Sponsor-CRO Communications.
• 2. Research in Emergency Situations.
• 3. Recruitment of Research Subjects.
• 4. Informed Consent for Participating in Clinical Research.
• 5. Assent of Children to Participate in Clinical Research.
• 6. Research Data Management.
• 7. Control and Accountability of Investigational Drugs.
• 8. Control and Accountability of Investigational Devices.
• 9. Adverse Event Management
• 10. Monitoring by a Sponsor of a Research Protocol.

  D- Regulatory:

• 1. Unaffiliated Investigator's Participation in Research.
• 2. Planned Protocol Deviations.
• 3. Unplanned Protocol Deviations.
• 4. Adverse Event Reporting - IND Safety Reports.
• 5. Research Records Retention.

  E- Fiscal and Financial:

• 1. Research Study Initiation Procedures - Administration.
• 2. Revenue Coordination for Research Patients.
• 3. Registration of Research Subjects
• 4. Payments to Research Subjects.
• 5. Professional Billing.
• 6. Invoice Payments and Accounts Payable Check Requests.
• 7. Research Contracted Services.
• 8. Procurement- Verification of Eligibility.
• 9. Clinical Research Budget and Coverage Analysis.

  F- Study Manager:

• 1. Standards for use of Study Manager^TM

  G- Time and Effort:

• 1. Payroll Reporting for Research Staff ( Exempt).
• 2. Payroll Reporting for Research Staff (Non-Exempt).
• 3. Payroll Reporting of Shift Differential (Non-Exempt).

  H- Swedish Research Center Administration:

• 1. Research Study Initiation Procedures -Administration.
• 2. Programs98 Database Maintenance and Administration Procedure.
• 3. Payroll Reconciliation.
• 4. Research Archiving Procedure.

  I- Federal Grant Applications:

• 1. Software for Online Federal Grant Applications.
• 2. Individual Account Registration with eRA Commons.
• 3. Download of SF424 Application for Federal Funding.
• 4. Principal Investigator Search for Funding Opportunity Announcements (FOA).
• 5. SF424 Application Format Requirements.
• 6. Completion of SF424 Application Components.
• 7. Principal Investigator Submission of SF424 Application to Swedish Research Center.
• 8. Principal Investigator Certification of Compliance with Federal Requirements (SF424 application).
• 9. Submission of SF424 Application to Grants.gov.
• 10. Principal Investigator and Signing Official Review of SF424 Application Errors.
• 11. Principal Investigator and Signing Official Verification in eRA Commons.