RAMS-IRB TRAINING
5TH THURSDAY WORKSHOP
MARCH 31, 2016
Outline of this Session:
Welcome, sign in, and introduction to the structure of RAMS-IRB 5 minutes
Complete pages 4-13 of the packet in pairs or small groups 15 minutes
Group discussion about pages 4-13 5 minutes
Complete pages 14-18 of the packet as a large group 15 minutes
Questions and answers about RAMS-IRB 5-8 minutes
Complete post-assessment 2 minutes
Take-Home Bonus! For extra skills training, take home a chapter of Word 2010 All-In-One for Dummies by Doug Lowe to read about redlining in Microsoft Word. Many additional training articles, videos, and tutorials are available at https://support.office.com for other versions of Word.
To set up a personalized training session, contact Megan Wright at [email protected].
Session Objectives:
1. Increase the confidence of experienced reviewers 2. Teach basic navigation skills to new and prospective reviewers 3. Answer questions about how RAMS-IRB works
Page 1 of 18
THE STRUCTURE OF RAMS-IRB
All Studies the IRB has received
Main Study Workspace of a particular study
Amendment Continuing Review Report Workspaces Workspaces Workspaces
Each amendment is Each continuing review Each report is separate separate (ex. _Ame1, is separate (ex. _CR1, (ex. _Adv1, _Adv2…) _Ame2…) _CR2…)
When approved, the Amendment workspace over-writes the Main Study workspace.
Here’s another way to picture it:
Main Study Workspace
Continuing Reviews Amendments
_CR1 _CR2 _Ame
_Ame2
Reports
_Adv1
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BREADCRUMB NAVIGATION
The gray bar across the top of the page is called “breadcrumb” navigation. It shows the trail of where you are within a workspace.
Many computer systems use breadcrumb navigation to describe the location of a specific file within a series of folders. Here is an example of where this training worksheet is stored on my computer:
C:\preslaned\My Documents\Trainings\5th Thursday handout.doc
In RAMS-IRB, the navigation will always follow the format of
Electronic File Room link > Main Study Workspace link > Submission Workspace link IRB > Study Title > Submission Title
If you ever get lost within a workspace, look at the breadcrumb trail and click on the study title link to be taken to the Main Study Workspace. You could also click the submission title link to return to the submission workspace.
Page 3 of 18
IRB COMMITTEE MEMBER HOMEPAGE
NAME OF IMAGE OF ACTIVITY DESCRIPTION OF ACTIVITY ACTIVITY My Home and
Logoff links
My Inbox tab
Upcoming
Meetings tab Reviewer & Investigator roles
Meetings link
IRB link
Help link
Submission workspace link
Page 4 of 18
IRB TAB – THE “ELECTRONIC FILE ROOM”
NAME OF IMAGE OF ACTIVITY DESCRIPTION OF ACTIVITY ACTIVITY
In Progress tab
Approved tab
Archived tab
Search tab
Search bar
Links to search by submission type
My Home link
Page 5 of 18
NEW STUDY WORKSPACE
NAME OF IMAGE OF ACTIVITY DESCRIPTION OF ACTIVITY ACTIVITY
Current State OR Information
View Study
Printer Version
button
View Differences
button
Log Private
Comment button
Log Public
Comment button
Page 6 of 18
Finalize Review
button Reviewer Note
Snapshot link
Finalized Review
link
Public comment
history item View Meeting Workspace
button Personnel name
link
Tab Display
options
History tab
Comments tab
Documents tab
Admin Docs tab
Reviewer Notes
tab
Change Log tab
IRB Information
tab
Paper History tab
Page 7 of 18
AMENDMENT WORKSPACE
NAME OF ACTIVITY IMAGE OF ACTIVITY DESCRIPTION OF ACTIVITY Current State OR information
Amendment Cover
Sheet buttons
View Modified Study
button
Printer-Friendly
Study button
View Changes
button
Log Private or Public
Comment buttons
Page 8 of 18
Approved Study link
Finalized Review
link
View Meeting
Workspace button
Personnel name link
Tab Display options
History tab
Comments tab
Documents tab
Reviewer Notes tab
Change Log tab
IRB Information tab
Page 9 of 18
CONTINUING REVIEW WORKSPACE
NAME OF ACTIVITY IMAGE OF ACTIVITY DESCRIPTION OF ACTIVITY View Continuing
Review button Printer-Friendly
Version button View Differences
button Log Private or Public
Comment buttons
Approved Study link
Reviewer Note
Snapshot link
Finalized Review
link
View Meeting
Workspace button
Personnel name link
Page 10 of 18
Tab Display options
History tab
Comments tab
Documents tab
Reviewer Notes tab
Change Log tab
IRB Information tab
Page 11 of 18
APPROVED STUDY WORKSPACE
NAME OF ACTIVITY IMAGE OF ACTIVITY DESCRIPTION OF ACTIVITY
View Study button
Printer Version button View Differences
button Log Public and Private
Comment buttons Tab Display options
History tab
Comments tab
Amendments tab
Continuing Reviews &
Closures tab Reports tab
Documents tab
Admin Docs tab
Change Log tab
IRB Information tab
Paper History tab
Page 12 of 18
MEETING WORKSPACE
NAME OF ACTIVITY IMAGE OF ACTIVITY DESCRIPTION OF ACTIVITY Current State
information Confirm
Attendance button
Decline Attendance
button
Agenda link
(same for Minutes)
Study ID link
Reviewer name link
Stop when you finish this page.
Page 13 of 18
ADDING REVIEWER NOTES Step-by-Step Directions Screenshot New Study: Amendment: Continuing Review:
EDITING REVIEWER NOTES Find the note within the smartform New Study: Amendment: Continuing Review:
OR…. Find the note in the Reviewer Notes tab
Step-by-step Directions Screenshot
Page 14 of 18
DELETING REVIEWER NOTES
Find the note in the smartform New Study: Amendment: Continuing Review:
OR… Find the note in the Reviewer Notes tab
Step-by-Step Directions Screenshot
Page 15 of 18
VIEWING CHANGES
NAME OF ACTIVITY IMAGE OF ACTIVITY DESCRIPTION OF ACTIVITY
View Study button
Printer Version
button
View differences
button
Change Log link
On Page ____ link
Link to view the most recent letter of approval
Submission link (see page about Breadcrumb Navigation)
Page 16 of 18
BUTTON/LINK DESCRIPTION AND USES SCREENSHOT
View property changes (shows the computer language for the changed fields and text).
Pros: Quick way to view simple Change Log link checkbox changes and revisions in text responses.
Cons: Can be confusing to read, need to know the smartform well to recognize the properties that change.
View a side-by-side comparison of the pages that were changed.
Pros: Quick way to compare lists. On Page ____ link
Cons: Changes are only redlined if viewed in certain internet browsers, so can be hard to see changes in text responses.
View redlined changes within the smartform. Recommended method
Pros: Best way to view amendments with many changes and to check reviewer note responses. Can view differences between the most recent version View differences and previous resubmissions. button Cons: Only shows those pages that the PI revised, so still need to read through the entire smartform to ensure the changes were made throughout. If a document is changed, it shows every page that has a document upload question.
Page 17 of 18
KEY DIFFERENCES BETWEEN EXPEDITED & FULL BOARD REVIEWS Expedited Study Full Board Study
“Finalize Primary/Secondary How to finalize a review “Finalize Review” button Reviewer’s Notes” button
What the review looks like A review form to be filled out A comments box The Panel administrator records the The reviewer clicks “Finalize Review” meeting decision on behalf of the Panel and then selects “Changes Required” in How changes are requested and changes are requested in a formal the first question letter from the Panel
When reviewer notes While you review the study before the While you review of the study should be logged and edited meeting AND during the meeting
When reviewer notes are After your review is finalized as After the Panel’s letter is sent to the seen by the study team “Changes Required” study team** Upload your redlined version when you Sending redlined finalize your review (click “Update” Email your redlined version to your documents from a reviewer next to the document, browse for your Panel administrator before the meeting to the study team file, and click OK) ** Caveat: Some RAMS-savvy study teams know that they can look at the reviewer note snapshot before the meeting. However, they cannot view the reviewer notes in the smartform or respond to them.
Page 18 of 18