The Research Process
What does the research process look like at UnityPoint Health - Des Moines? Our office will help with all of these steps.
- There is interest in a drug, device or particular study
- We determine we have the right patient population
- We assess feasibility of conducting the study at our facility
- Negotiate a budget and contract with the study sponsor
- Approval by the Institutional Review Board (IRB)
- Staff education
- Subjects are identified, consented, and educated about the study
- Data is collected, adverse events are reported
- The study sponsor visits the site to monitor our study data to be sure we are following the protocol, federal regulations, and Good Clinical Practice Guidelines
- The study is completed due to meeting enrollment target or an interim analysis showing the study should not continued
- Our site is closed by the sponsor, study drugs/devices are returned to sponsor
- Data is stored for two years past the FDA approval for the specific indication for which the study was testing.
We have helped contribute to the safety and efficacy data of a drug or device for a particular disease. Possibly the drug or device will be FDA approved and change clinical practice, go on to be further studied, or the study may have shown it is futile to continue testing. All of these are important! Ultimately, we have helped bring new drugs and devices to the people of Iowa.