After going live, occasionally clients will find that a previously approved study was not entered into the conversion sheet and needs to be added to IRBManager. The following provides the steps needed to add that study to the system along with updating the approval information, adding study-site contacts and events, and forwarding emails into an event. A document has been attached to this article that can be downloaded for your convenience.
Create the Study
- Click <Create Study> in the top navigation bar.
- Optional: Choose a study type if this option is being used within your IRBManager.
- At a minimum, you will need to complete the following components on the first screen for creating a study:
a. Study- The assigned study number. b. Committee- Select the appropriate committee from the "Committee" drop-down. c. Title- The approved study title. d. Year- Update “Year” to reflect the year the initial application was received.
- It is recommended that you also fill out either “Last Review”, “Next Review”, or a user defined field for review level, if you have one, and any other user defined fields that you need to keep track of (I.e. Expedited Category).
- Click the Next Step --> button.
- On the second page, complete at least the following:
a. Site- Choose the correct study-site from the "Site" drop-down. b. PI- Enter the principal investigator’s name and choose the correct contact from the drop-down. NOTE: You can click [Add New] within the drop-down to add a new contact if the principal investigator is not an existing contact within the system. If you need to add a new contact, make sure you provide, at a minimum, a prefix (Dr., Ms., Mr., etc.), first name, last name, and an email address. c. Status- Select an option from the drop-down.
- Click the Add button.
After you have created the study, you will need to complete the following within the new study’s Study Details screen:
Add Study-Site Contacts
Add any additional study contacts by clicking the Add Contact link along the left, which is listed specifically under “Study-Site”.
- Add any additional study contactsby clicking the Add Contact link along the left, which is listed specifically under “Study-Site”.
a. Name - Begin typing in the contact’s name and select the correct contact. Again [Add New] allows you to add a contact that is not currently listed within the IRBManager. b. Role - Select the appropriate role from the "Role" drop-down. c. Primary - Optional: This checkbox is not being used in some IRBManager clients. Select the "Primary" checkbox if the new contact is the primary person in that role. d. Remove after - Optional: Provide a date if the contact is a temporary study contact with a defined participation period.
- Click the Add Contact button.
Update the Approval Information
- Click Approval: in the "Study-Site" section toward the middle of the page.
- Enter each historical approval period (as determined by initial approval and continuing approvals) by clicking the New Approval Period link along the left side of the page.
- Provide the following information for each approval period:
a. Type - Can be Exempt or Expiring. (There is an additional option for Non-Expiring that can be added if you need it. Please email firstname.lastname@example.org for assistance.) b. Approval Date - The earliest approval date entered will show on the Study Details screen as the "Initial Approval". c. Approval Length - Not needed for an exemption. This defaults to 12 months. If you change this approval period, click on the calculator icon next to it to automatically calculate the Expiration Date. d. Expiration Date - The system will warn you if the expiration date overlaps any other expiration date by more than 30 days.
- Click the Add button.
Add Study Events
- Click the Add Event link on the along the left, which is listed specifically under the “Study-Site” heading.
- Select the event type in the drop-down in the pop-up window.
- Click the Add button.
- The “Started” date on the right will be auto-completed with today’s date. You need to update it to reflect the actual start date of the event.
- Fill in the “Completed” date on the right if the event has been completed.
- Under “Steps” at the bottom of the page, fill in the “Actual” dates column for all steps that have been completed and change the “Complete” drop-down from “No” to “Yes”.
- Click either the Save and Stay or Save and Done button at the bottom of the page.
Add Attachments within the Event
- Click the Attachments (#) link on the left under ”Actions”.
- Click the Add Attachment link on the left.
- Provide a name for the attachment and select the type of document from the drop-down.
- To select the document, you can either click the Select button or drag and drop the file into the white box to the left of “Select”.
- Click the Attach button.
Attach Emails from Outside IRBManager within the Event
- Click the Show Inbound Email Address icon () next to “Event” heading in the “Event” section.
- Click the Copy Address button in the pop-up window.
- Go to your email application and click the Forward link or icon within the email to be attached within the event.
- Paste the address copied in step 2 into the “To” box and send the email. It will appear under the “Emails” section just above the event steps.