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Industry Initiated Clinical Research
Confidential Disclosure Agreement (CDA)
Feasibility
Preparation for Submission
Training
Recruitment and Retention
Medicare Coverage Analysis (MCA)
21 CFR Part 11 Compliance
Conducting a Device Study
Approvals Needed for Research
Budget Development and Negotiation
CRO Account Information Forms
Study Submission Workflow
Annual Report of Outside Relationships (Annual Form)
Investigator Form (IF)
Financial Interest in Research Disclosure Form
Start GCO Application
IRB Submission
Contracts & Budget Submission
GCO Submission
Local MAC Approval for Device Trials
OnCore CTMS (Clinical Trials Management System)
Site Initiation Visit (SIV)
Epic Registration of Clinical Trials
Translation and Interpretation Services for Research
Study Management
Financial Management
Monitoring and Audits
Study Closeout or Termination
Document Retention and Disposal
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Navigate Industry Initiated Clinical Research
Industry Initiated Clinical Research
Confidential Disclosure Agreement (CDA)
Feasibility
Preparation for Submission
Training
Recruitment and Retention
Medicare Coverage Analysis (MCA)
21 CFR Part 11 Compliance
Conducting a Device Study
Approvals Needed for Research
Budget Development and Negotiation
CRO Account Information Forms
Study Submission Workflow
Annual Report of Outside Relationships (Annual Form)
Investigator Form (IF)
Financial Interest in Research Disclosure Form
Start GCO Application
IRB Submission
Contracts & Budget Submission
GCO Submission
Local MAC Approval for Device Trials
OnCore CTMS (Clinical Trials Management System)
Site Initiation Visit (SIV)
Epic Registration of Clinical Trials
Translation and Interpretation Services for Research
Study Management
Financial Management
Monitoring and Audits
Study Closeout or Termination
Document Retention and Disposal
