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Fundamentals of Research at ISMMS
Industry Initiated Clinical Research
Investigator Initiated Clinical Research
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Fundamentals of Research at ISMMS
Industry Initiated Clinical Research
Investigator Initiated Clinical Research
Other Research
Basic Science
CTSA Network Central Resources
Investigator Initiated Clinical Research
Getting Started
Pre-Protocol Development
Technology Commercialization
Funding Resources
Training
ISMMS Approvals Needed for Research
Develop Proposal
Protocol Development
Multi-Site Study Support
Grant Proposals and Applications
Budget Development
Device Studies
Submission Process
Annual Report of Outside Relationships (eDMS Disclosure Profile)
Triggering Event (TE)
FCOIR – Research Trigger Form (project-specific form)
Suspension and Debarment (S&D) Form
Start GCO Application
FACTS – For-Profit Clinical Research Agreements
GCO & Extramural Submission
Regulatory Requirements
IRB and IACUC Approvals – When Do You Need to Submit?
IRB Submission
IACUC Submission
FDA
Do you Need an IND?
Do you Need an IDE?
ClinicalTrials.gov Registration and Reporting
Award Setup and Management
Award Setup
Award Management
Study Activation and Management
Study Activation
Study Management
Recruitment and Retention
Epic Registration of Clinical Trials
Translation and Interpretation Services for Research
Monitoring and Audits
Closeout
Award Closeout
Study Closeout
Publications
Data Management
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Navigate Investigator Initiated Clinical Research
Investigator Initiated Clinical Research
Getting Started
Pre-Protocol Development
Technology Commercialization
Funding Resources
Training
ISMMS Approvals Needed for Research
Develop Proposal
Protocol Development
Multi-Site Study Support
Grant Proposals and Applications
Budget Development
Device Studies
Submission Process
Annual Report of Outside Relationships (eDMS Disclosure Profile)
Triggering Event (TE)
FCOIR – Research Trigger Form (project-specific form)
Suspension and Debarment (S&D) Form
Start GCO Application
FACTS – For-Profit Clinical Research Agreements
GCO & Extramural Submission
Regulatory Requirements
IRB and IACUC Approvals – When Do You Need to Submit?
IRB Submission
IACUC Submission
FDA
Do you Need an IND?
Do you Need an IDE?
ClinicalTrials.gov Registration and Reporting
Award Setup and Management
Award Setup
Award Management
Study Activation and Management
Study Activation
Study Management
Recruitment and Retention
Epic Registration of Clinical Trials
Translation and Interpretation Services for Research
Monitoring and Audits
Closeout
Award Closeout
Study Closeout
Publications
Data Management
