iProtocol Guide

Creating a New iProtocol

To create a new “blank” protocol, select the “Create Blank Protocol” link on the Protocol Management page. You will be directed to add a title and a brief description. If you are transitioning a previously approved protocol into iProtocol, include the IRB-SBS number that was previously assigned to the protocol. The protocol will be issued a new number. Please note this option will only be available for the first year of the system.

You can also create a new protocol using a previously approved protocol as a template by making a “copy” of the protocol. Select the “copy” link below the desired protocol number. In the next page, indicate that the protocol is a new protocol and provide a new title. The copy will have a new number and title but will retain all the text and attached documents from the previous version.

Don’t use the “back” button.

Using the back button won’t undo an action. If you want to undo something, look for the “edit,” “remove,” or “undo” buttons which will help you to remove or edit content.

Don’t worry, it’s saved!

iProtocol is regularly saving content as you add it into the protocol text boxes but for added measure, you can use the “save” button at the bottom of each text box.

Some formatting can be copied.

In designing this form, we had to choose between cool formatting tools and more robust data processing and we chose the latter so that we could be more efficient in our reviews. However, the boxes will allow you to paste bulleted lists and numbered lists, as well as retain paragraph breaks, etc. If you want to include bullets or numbers, consider typing your response in a Word document (or similar program) and paste it into the protocol text box.

Upload more complicated formatting.

There are several places where documents can be uploaded to the protocol form. If you need more complicated formatting tools, like tables, create an addendum Word document and upload it in the “Study Overview” section, for example. PDF documents and images can also be uploaded.

Uploading a file
  1. Select the “upload” link.
  2. Select “choose file” and then browse for the file that you want to upload. When you find the file you want, select the file and then select “Open.”
  3. Select “Upload File.” You will see a “Protocol was successfully updated” message. Click on the “return to protocol” link to continue adding content to the protocol
Removing a file
  1. Select the “remove” link.
  2. Select the box next to the file that you want to remove. You can select more than one file to remove.
  3. Select “Remove File.” You will see a “Protocol was successfully updated” message. Click on the “return to protocol” link to continue adding content to the protocol.
Recovering a file:
  1. Deleted files are stored in the “Trash” section at the bottom of the protocol. Look for the file in the “Trash” section.
  2. Select the link for the file that you want to recover. It will download to your computer.
  3. To add the file to a specific section in the protocol, see the directions above for uploading a file.

The iProtocol guide includes specific guidance for each section of the protocol but here are some general tips to keep in mind as you develop your content.

Be complete:
  • Make sure that you provide an accurate picture of your study to the IRB-SBS. The protocol questions are meant to encourage you to explain your study to the IRB-SBS and to provide them with the information that they need to do a complete review. If you leave out information, the IRB-SBS is unable to grant full approval until they have their questions satisfied.
  • Make sure that you provide all of the documentation requested by the IRB-SBS (i.e. consent forms, instruments, advertisements); if you describe it in your protocol the IRB-SBS will want to see it. iProtocol is designed to prevent you from submitting your protocol until you provide a minimum level of responses but only you will know if the protocol is truly completed.
  • Make sure that you fully describe your experience and expertise in your field of research so that the IRB-SBS can feel comfortable with your ability to successfully engage the targeted population for your study.
Be concise:
  • In keeping with the first point, don’t say more than you need to. Remember that your reviewer is often a busy professional who won’t be able to wade through pages and pages of theories.
  • Make every response to the point, providing succinct answers loaded with information.
  • Be careful not to repeat yourself continuously. Some of the questions ask for aspects of the study from different perspectives, so some repetition will be necessary. However, if you find that you are saying the same thing over and over again, review some of the questions and see if there is information that you could include that hasn’t already been stated.
Be clear:
  • Submitting a well-organized protocol will not only make review easier for your reviewer, it will help them to understand what you are proposing to do.
  • Make sure that your writing is error-free, particularly in your consent documents.
  • Don’t overburden your reader with technical jargon. Although your reviewer will be an expert, not every Board member who will read your protocol will have experience in your niche of the field. If your protocol includes technical equipment, instruments, and/or technical jargon, make sure to provide definitions and explanations. If this information is in the consent form, make sure that it is clearly explained at a sixth grade reading level.