Institutional Review Board (IRB) New Protocol Application
IMedRIS Software Instruction Sheet
The IRB Office is delighted that you are requesting to do research at Baptist Health. The following are instructions to assist you in the new protocol application process to the Baptist Health LexingtonIRB. Should you have any questions or need assistance in this process, please contact the IRB Office at 859-260-6074.
Step 1 – Obtain a user id and password
If this is the first time you have applied to the IRB, you will need to contact the IRB office to get a user id and password for the iMedRIS submission software system.
Step 2 – Create your own password
Once you have been assigned a user id and password, you can log into the submission software system located at . For first time users, you will be prompted to change your password.
Step 3 – Add a new study
Click on the blue tab labeled “Study Assistant” on the left side of the screen. Then click on “Add a new study”.
Step 4 – Protocol general information
Complete all of the information in the blanks (Note the question about whether or not you are using Subject Management. This references a section in the Imedris Software for clinical intervention protocols. Please discuss with the IRB Office if you do not know how to answer this question).Click Save and Continue to Next Section.
Step 5 – Select department(s)
This section allows you to add any departmentthat is associated with the study. The system will automatically list the study in the department that is in your software user account. Change the department if necessary by adding a different department here. Once completed,click on Save and Continue to Next Section.
Step 6 – Add key personnel
The next section is where you add all of the key personnel involved in the study. Note that the principal investigator and anyone listed as project contacts will receive all electronic (email) study correspondence. Also note that you are required to add the Vice President in your pathwayas a designated department approval. Your vice presidentis required to sign off on the feasibility of the study. Complete screen and click on Save and Continue to Next Section.
Step 7 – IRB application
Now you may begin to complete the IRB application for a new protocol. Fill in all of the answers until the application is complete and then click Save and Continue to Next Section.
Step 8 - Comments
The next screen allows you to add any other comments you wish to add to the submission. This is optional. When finished click Save and Continue to Next Section. View the next screen which attaches your completed application to the submission packet and then click Save and Continue to Next Section.
Step 9 – Add consent document
The next screen allows you to attach a consent document, if applicable. Click the “Add a New Consent” button. You will have three options to upload. Typically you will use one of the first two options.
The first option, “Add an informed consent from the list of Informed Consent Template Documents?”,allows you to pull up the Baptist Health Lexington IRB approved consent template and adapt it to your study. Instructions on how to adapt and save the consent document to your application are on the screen.
The second option, “Add an informed consent from an existing electronic document you already have?”,allows you to download a file from your desktop. You will give the document a title and browse for it on your computer and click “Save Consent”.
Once the consent document is saved to your study, click Save and Continue.
Note: Your consent document is required to be adapted to the Baptist Health Lexington template.
Step 10 – Add study documents
If you have a study document, such as the protocol, investigator brochure, advertisements, questionnaires,CV, training certificates, etc. to include with your initial submission, you attach them here. Click the“Add a New Document” or “Add Multiple Documents” button. You will be prompted to browse your documents to attach. When the documents are added, click on “Save Document(s)”. Then click onSave and Continue.
Step 11 – Add Vice President signoff
You have completed the initial application. Click on Signoff and Submit. Click “Yes” to “additional personnel for routing”. Click on Save and Continue. This is where you add all personnel who are required for sign-off including your Vice President for feasibility review. Once you have added the key personnelfor sign-off, click “yes” that you have completed your selection of required signatures and then hit save and continue.
Step 12 – Sign and Submit
This screen allows you, as the investigator, to sign off that you approve the study as it is being submitted. Click the approve circle and enter your user id and password. Then click the Save signoff button. Save Signoff
The study has now been routed to the other required signoff personnel. Once the signoffs are completed, The IRB will either receive the submission or you will receive a denial notice from the system stating that your Vice President did not approve the feasibility of the study.
Version.2.14.14