For Clinical Trial Investigators

At Erlanger Institute of Clinical Research we work to facilitate the submission, approval, and maintenance of the clinical trials conducted within Erlanger Health Systems.

If you are interested in initiating a clinical research study with Erlanger,  please contact us directly or submit an inquiry on our website. We offer the following services to our investigators:

Pre-study/start-up activities:

• Trial search
• Feasibility surveys
• Agreement (CDA, NDA, MTA, CTA) process & management
• Site budget analysis & budget negotiations
• IRB initial submission (local and central)
• Regulatory submission
• Billing documents (MCA, billing grid / research orders)
• Training teams

Study conduct:

• Recruitment
• Database search / Prescreen
• Participant Enrollment
• Coordination of care & study activities
• Data management / CRF completion
• Lab collection & processing
• Regulatory & IRB submissions
• Dispense medications
• Drug / Device Accountability
• Patient Education
• Facilitate Monitors
• Audits
• Continuous Training
• Safety Reporting
• Invoice for services
• Process study charges

Post-study/closure:

Regulatory:

• Review and ensure documents are current, complete, accurate and filed appropriately.
• Resolve any pending monitor findings/queries.
• Submit study closure with IRB.
• Final report to regulatory authorities.

Research records:

• Review and ensure all records are current, complete, accurate and filed appropriately.
• Ensure notes-to-file exist for any deviations/occurrences that require additional explanation.

Investigational product:

• Complete inventory assessment.
• Reconcile any product/supply discrepancies.
• Return/destroy product/supplies according to sponsor/CRO instructions.
• Maintain all required documentation of event.