Release Notes Version 1.6
August 20, 2007
Overview of Changes for Core Staff
Application Form Changes
Click here for a spreadsheet listing all of the questions and logic in the Application, AE/ORIO and SCR forms with Release 1.6 changes highlighted in yellow.
- The Jump To menu now displays required section names in bold and non-required section names in italics. The display of each section name dynamically updates as the user completes the application.
- Section 45 (End of Application) has been redesigned and now allows users to execute the following activities, from within the form:
- Notify Study Team Members to Accept Role
- Error Check
- Move to Ready to Submit Inbox
- Ability to submit submissions (e.g., submit application from the application)
- In the hide/show errors window, error messages that exceeeded 256 characters were cut off. This problem has been corrected.
- A two-year approval option is now available for IRB Behavioral Sciences and IRB Health Science applications. To receive two-year approval, an application must not be in any of the following categories:
- FDA regulated
- federally funded
- include clinical intervention
- involve prisoners
- require Certificate of Confidentiality
- Question 1-6.6: Now includes a selection for the new Phase 1 Unit Cancer Center program.
- Question 3-2.1: The validation rules for Cancer Center Subject Participation have been corrected.
- Question 5.3: This question must now be answered Yes for all studies utilizing GCRC resources.
- Sections 7-1, 7-2: Validation has been added that will not allow the application/amendment to be submitted if the study does not involve direct interaction with subjects and any question in section 7-1 or 7-2 has been answered.
- There was a logic error that under certain conditions resulted in closing the application after the user completed section 7. This problem has been corrected.
- Question 9.1: The validation rules for Subject Populations have been corrected.
- Question 10-4.2 has been changed.
|"Is this a request for a waiver of the requirement to obtain informed consent..."
"Is this a request for a waiver of documentation of informed consent..."
- Section 12 now includes the following new exemption category:
Research in which study activity is limited to analysis of identifiable data. For purposes of this research study, all research subject interactions and interventions have been completed and the data contiues to contain subject identifiers or links. The Research is not federally-funded, regulated by the FDA or conducted under a Certificate of Confidentiality. (This category is for IRB Health and IRB Behavioral Sciences use only.)"
- Question 14.9: Regarding risk of birth defects. The answers "Possibly or Definitely" and "Unknown" now require answers to questions 14.9.1 and 14.9.2.
- Section 12: Exemption category descriptions that exceeded 256 characters were being cut off in the printer-friendly version of the application. This problem has been corrected.
- Questions 15.3.23 and 15.3.24: Regarding "off label" use of FDA Approved Agents: An answer to one of these questions is now required.
- Question 18.1: Regarding biological speciments now requires an answer.
- Question 37.1 has changed from:
"Do any of the study procedures pose significant physical or psychological risks to women who are or may be pregnant, or to a fetus?"
"Is there a potential that any of the study procedures pose significant physical or psychological risks to women who are or may be pregnant, or to a fetus?"
- New Question 44.2:
"If the study sponsor requires that the IRBMED approval letter contain a list of supporting documents, list the names of the documents in the box below as they should appear on the IRBMED approval letter."
- Documents that are uploaded to the application will now be listed in alphabetical order.
AE/ORIO Form Changes
- Question 4.2.11 has been changed from:
"Begin comments with any information needed to display on the table in the main form (e.g., a document identifier you need readily visible for sponsor requirements). Include detail of events as PI or sponsor deems necessary and appropriate."
These comments also display on the table in section 4.2 of this submission (e.g., additional information about this event). These comments do not appear on the approval letter."
- Question 6.2.5 is now optional.
- New Question 14.1:
"If the study sponsor requires that the IRBMED approval letter contain a list of supporting documents, list the names of the doucments in the box below as they should appear on the IRBMED approval letter."
Amendment Form Changes
- After receiving a notification that the amendment copy is available for editing, some users have been unable to access the amendment, due to the "Your Amendment is Being Created" page blocking access. This problem has been corrected.
- Exiting an amendment form at times resulted in an error message. This problem has been corrected.
SCR Form Changes
- New Question 1.1.2:
"If terminating, reason for termination (e.g., study is compete including data analysis, funding was not obtained, investigator relocated)."
- New Question 1.2:
"Describe any significant new findings or information developed during the course of this research or other associated research that may relate to a subject's willingness to continue participation. Provide literature citations and/or links to publications. This field may also be used to communicate additional information to the IRB that is pertinent to the review of this SCR."
- New Section 1-2 This section allows for renewal of Humanitarian Use Device (HUD) studies.
Letters and Notification Changes
- There was a problem with links in notifications for users who view email in plain text mode (vs. HTML). These links will now take users directly to the submission noted in the email. eResearch still recommends that users set their email client to display HTML.
- The date of approval on the amendment approval letter for Expedited and Full Committee Review was displaying incorrectly. This has been corrected.
- Co-investigators, study coordinators, and study team members who elect not to receive notification will now only receive the following minimum set of notifications:
- IRB approval and disapproval letters
- Notifications of Voluntary and Involuntary Holds and Suspensions
- 30 day and Final expiration reminders
- The approval letter for Exempt Continuing Reviews was not displaying the entire text of the exemption category. This problem has been corrected.
- The Continuing Report Approve with Contingencies and Action Deferred Pending Study team notifications incorrectly referenced an obsolete activity, Create Related Amendment. This has been corrected.
- In the Withdrawn and Changes Requested by Study Team activities for Adverse Events, the notification setting has been updated so the notification will be sent to all study team members that are authorized to receive notifications.
- When a change to the study team occurred while a Continuing review was in progress, the updated list of study team members was not displaying correctly in the Continuing Review final outcome letters. This problem has been corrected.
- The Changes Requested by Ancillary Committee activity for amendments was not sending a notification. This problem has been corrected.
PI & Study Team Process and Workspace Changes
- The New Continuing Review button is no longer available from the Home Workspace of an approved Emergency Use study.
- The status meter that appears at the top of each submission workspace has been redesigned to more clearly indicate the status of the submission.
- In Study Team Workspace, the Inbox has been redesigned. The Study Team Inbox now sorts submissions into the following sections:
- Ready To Submit
- Need to Accept Role
- Require Study Team Action
- Welcome text has been removed from the Home Workspaces.
- The title of the Home Workspace has changed from Home for user name; to Home Workspace for user name.
- Documents uploaded to section 1-1.4 were not listed in the Documents tab. This problem has been corrected.
- Updating the list of users who are authorized to order radiopharmaceuticals or users who are authorized to prescribe radiopharmaceuticals no longer clears out the previous acceptance if other users who were assigned those roles had previously accepted their role.
- The All Issues tab in the Amendment, Continuing Review and Adverse Event/ORIO workspaces now uses the same format that the All Issues tab in Applications uses.
- On the SCR Approved Study summary, the selected IRB approved documents list did not provide revision history. This problem has been corrected.
- The PEERRS expiration date was not displaying correctly in the study team detail window of the Amendment, Continuing Review and Adverse Event/ORIO. This problem has been corrected in the Amendment and Adverse Event/ORIO.
- The expiration date column has been removed from the Approved Documents area of the Documents tab in the Application workspace.
- When a Continuing Review is approved, the last SCR Approval Date of the parent Application is now updated.
- A new tab, Change Tracking, has been added to the Exempt workspace.
- Study Team notes were not working properly for Adverse Events/ORIOs. This problem has been fixed.
- The Decline Right to Rebut activity was generating an error. This has been corrected.
- Sometimes study team members would get a "You do not have permission" error when attempting to edit (replace) a document on a follow-up adverse event. This has been corrected.
- Prior to this release, eResearch tracked all PEERRS modules. Now eResearch will only track and display the human subject modules:
- Human Subjects – Biomedical Sciences
- Human Subjects – Biomedical and Health Sciences
- Human Subjects – Behavioral Sciences
- Links to Identified Issues in Amendments were corrupted. This problem has been corrected.
- The following instructions have been added to the Internal Server Error page:
"The system is currently not able to process your request. Please try again later. If the problem persists, please contact the MAIS Help Desk at 734-936-7000 or email@example.com."
Review Commitee Process and Workspace Changes
- A printer-friendly version of the Reviewer Checklist has been added.
GCRC Process and Workspace Changes
- GCRC core reviewers are now automatically assigned when a study arrives in the GCRC Inbox.
- GCRC Nurses home workspace now has the ability to sort by PI.
- The GCRC Reviewer Summary Report had an error if the review had no checklist items. This problem haas been correct, and additional enhancements were made to the report.
Core Staff Process and Workspace Changes
- There was an error with the auto-generated contingency created when a key study team members are not PEERRS certified. This problem has been corrected.
- If an amendment is submitted which removes the GCRC or the PRC from a study, those committees are now notified.
- Auto-generated contingencies will not contain a value in the created by field. Previously, the created by field displayed IRB Staff Reviewer.
- The Submission Summary for Adverse Events will now display the current risk level and expiration date.
- The inbox staff notes for Continuing Reviews were often incorrectly displaying the original review type of the parent Application. This problem has been corrected.
- The Changes Requested by Core Committee activity referred to the Edit Identified Issues, which is no longer in use. The activity form now refers to the Edit Open Issues activity.
- A new activity, Unassigned Expedited Reviewer, has been added to the Core Committee Staff workspace for applications, amendments and SCRs. A new activity, Unassign Single Member Reviewer, has been added to the Core Committee Staff workspace for adverse events/ORIOs. Both activities do the following:
- Remove all currently assigned reviewers
- Change the state of their review to withdrawn
- Change the state of the submission to core committee staff review
- Change the state of the staff review to Assign Reviewers
- Staff must now select a reviewer when executing the Refer to Designated Reviewer activity to review contingencies. An error message will appear if a reviewer is not selected.
- Auto-generated contingencies will no longer be created for items that were responded to with “no electronic documentation available” prior to Release 1.5.
- If a Scheduled Continuing Review is changed from a renewal to a termination, the related reviews will be updated to reflect the change.
- A Parent Project Title column has been added to Health Unassigned Submissions in the Unassigned tab of the Core Committee Staff home workspace.
- The reviewer field on the submission summary has been removed.
Institutional Biosafety Committee (IBC)
PI/Study Team Changes:
- Section 3: Biosafety Level information has been moved to Section 12.
- Section 4: The printer friendly version of the IBC registration now displays the exempt category.
- Questions 10.4 & 10.5: A text box has been added for additional information.
- Section 13: A text and upload functionality have been added.
- The IBC Jump To menu now displays only required section names in bold. The display of each section name dynamically updates as the user completes the application.
- IBC registrations now display on the In Progress and Completed tabs of the PI and Study Team Home Workspace.
- A new choice, Other, had been added to Registration workspace.
- Introduction page has been added to the beginning of IBC registration with detailed description of IBC and the responsibilities of the PI and the Study Team.
- In the Summarize Review Activity, added a set of commonly used phrases to describe the animal containment section of IBC. Staff can now choose from this series of phrases and are no longer required to manually enter each phrase.
- The IBC interested party role displays on the home workspace for people assigned to that role.
- There is a flag on the core staff workspace to indicate when reviewer reviews have been submitted.
- Letter templates have been updated to include IBC information and useful links.
- New Activity: The Submit Review activity will be used by reviewers to write and submit their review and recommendation.