Starting a New Protocol

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Starting a New Protocol
To get started, log in to iRIS. Use your normal UofL login credentials. Iris page.png
Then click the Study Assistant tab -> Add New Study or the Add New Study button. Iris main page.png
Select 'IRB Study Application' and click the Start selected Application button. Routing.png


1.0 General Information
Fill in the formal title of your study and the short title you want displayed in your My Studies list. 1.0 gen info.png
Click the Save and Continue to Next Section button at the top right of the screen.


2.0 Setup Department Access
The primary department/division of your PI should be pre-filled. Click to select if it is not. If your PI's primary appointment is in a different institution, please contact the Research Director for guidance. 2.0 depts.png
Click the Save and Continue to Next Section button at the top right of the screen.


3.0 Grant Key Personnel Access to the Study
3.1 should have your PI pre-filled.
3.2 is you and any other Co-PIs, other residents, medical students, other faculty. You should be a CoPI. Add the Research Director as CoPI if you want editing help. Other residents or medical students helping with data collection should be added in (B) Research support staff. Click the green Add User button, search for the person, and click the green check mark next to his/her name to add to your protocol. These folks should be added as a Clinical Research Associate or Participating Clinician. Anyone who is going to view your data, access the medical record, or interact with research participants (including consenting) needs to be added here. People viewing only de-identified data (e.g. statistician) do not need to be in your protocol at all. 3.0 ksp 1.png
3.3 Study contacts - your PI will automatically receive any communication about the study. You should make sure you are there also. You also need to add the contact Research, University Medical Center to this list (search for research and it will come up). 3.0 ksp 2.png
Click the Save and Continue to Next Section button at the top right of the screen.


4.0 Research Nature
Select Biomedical. 4.0 type of research.png
Click the Save and Continue to Next Section button at the top right of the screen.


5.0 Application Types
Select IRB Application.

If you are submitting for an exemption from review, you need to select Non Human Subjects Research (NHSR) and go to this page for further directions.

5.0 app types.png
Click the Save and Continue to Next Section button at the top right of the screen.


6.0 Study Information
6.1 A brief lay description of your study - think Junior High/High School reading level and about 1 paragraph. 6.1 brief explanation.png
6.2 A brief lay description of your intervention. If this is a chart review, then say so and describe what you are going to collect. 6.2 proc explanation.png
6.3 Research methods - Again a brief lay description of your study design and planned analyses. Include a power analysis if appropriate.
6.4 Type of article - Vast majority of our studies will be N/A. If you are doing a drug or device study or you are not sure, contact the Research Director for guidance.
6.9 Select no - unless you are actually charging the subject.
6.11 - Is this study blinded? Select the correct choice for your study.
6.12 - Clinicaltrials.gov - THIS IS IMPORTANT. If you are doing any kind of intervention, you need to register your study. Even if it is low risk. If your study is observational, you do not need to register. 6.12 clinical trials.png
Click the Save and Continue to Next Section button at the top right of the screen.


7.0 Sponsor
You need to identify any sources of funding, even if it's departmental. If your faculty is funding any part of your project with CME/Flex dollars, this counts as Internally Supported. You must also declare if you are getting supplies etc. from any organization. 7.0 sponsor.png
Click the Save and Continue to Next Section button at the top right of the screen.


8.0 Study Sites
This is where you tell the IRB where you are going to be doing your study. If you are doing a chart review, you can just select 'UofL Facilities'. If you are going to be interacting with patients, you need to select where you will be. Importantly, if you are going to be at a private office or outside facility, you need to obtain a letter of agreement/support from that site prior to submitting your protocol. This is in addition to checking the correct box on this list. The Research Director can help you with this. 8.0 study sites.png
Click the Save and Continue to Next Section button at the top right of the screen.


9.0 Review Type
9.1 What type of protocol do you need?

Many of our studies are Expedited. If this is what you need, make that selection and click the link below to continue with instructions for Expedited protocols. If you need to submit an Exempt protocol, select Exempt and click the appropriate link below for further directions. If you are submitting a Full Board Study, you need more than this tutorial. The IRB, your PI, and/or the Research Director can help you with further instructions.

Select the appropriate category from 9.2 and provide the justification in 9.3. If you find that your study does not fit into any of the categories, you may need to select a different protocol type.

9.0 review type exped.png
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Further instructions
Exempt

Expedited