Platform updated to latest Portal version (Huron Portal 8.1)
Document Compare feature for word documents
Most pop up pages in forms eliminated
IRB Changes
Expanded Access/Emergency use application revised to include expanded access for drugs. The form was changed to support this and ask for the appropriate information.
Expanded Access/Emergency use Form Changes
Section 1.5: After drug is selected in 1.5, section 1.6 will appear and the user will now be prompted to choose between Emergency Use or Expanded Access (Compassionate Use).
Section 1.6.5: A new question appears so that the user can indicate if prior authorization was requested to use an alternative IRB review procedure.
Section 1.10: This section was re-worded for clarity.
Expanded Access/Emergency use Main page Changes
The title on the view and edit buttons will now reflect the type of submission indicated in the application.
The title above the summary area will now reflect the type of submission indicated in the application.
Added campus to the summary area.
Individual Investigator Agreements: The email that gets sent to the person requiring to sign now has a link that allows the person to sign the agreement even if the study team member does not have access to the study.
Study Form Changes
Page 4: NIH funding question 4.1.1. added. For studies that possibly receive NIH funding, a question is asked directly as to whether the study will receive NIH funds.
Page 4b: Question 4b.5. reworded for clarity
Page 9: GDS question (9.5) only shows up if NIH funding is checked (4.1.1). The questions also includes guidance, showing as a round icon with a question mark at the end of the question.
Pager 24: The warning regarding the FDA not allowing waivers of consent has been removed.
Page 26: for USC, at appropriate times there are notes that show up regarding USC's data security policy and data sharing policy.
The following questions do not show up for CHLA: 4.1.1, 12.3, 22b.2, 22d.2, 22e.2
Various miscellaneous bug fixes and enhancements
IACUC Changes
Form Changes
Renewal Form: Question R1.2.1. is removed and is replaced by an info box if R1.2. is Yes.
Staff
DMR can now be for n number of reviewers and daily reminders will be sent to reviewers whom have not done their reviews
Forward for DMR now have the ability to select multiple alternates and only those alternates selected will be notified about the DMR and can vote
Contingency Review Votes and Final Recommendations are now reflected in the History Log
Internal Messaging System is now enhanced to auto select the last set of recipients
There is now an ability to reassign the Vet in Vet Review
Various miscellaneous bug fixes and enhancements
IBC Changes
Form Changes
Users can no longer open amendments on expired BUAs
Users can now modify the Project Title
Added a Messaging System between PI/Study Team & IBC Staff
Page 1 is reorganized and renumbered; New questions (1.1., 1.2. and 1.12. added to support CHLA IBC) ; Updated validation to reflect the changes
1.1. Authorized Personnel becomes 1.3.
1.2. Recombinant or Synthetic Nucleic Acids becomes 1.4.
1.2.1. Are any rDNA materials used in human subjects becomes 1.4.1.
1.2.2. Is this a clinical trial becomes 1.4.2.
1.3. Biologically Derived Toxins, including Select Agents becomes 1.5.
1.4. Potentially Infectious Microorganisms become 1.6.
1.5. Potential Dual Use Research of Concern 1.7.
1.5.1. Does this research enhance the harmful consequences of the agent or toxin becomes 1.7.1.
1.5.2. Does your research disrupt immunity becomes 1.7.2.
1.5.3. Does your research confer to the agent or toxin resistance becomes 1.7.3.
1.5.4. Does your research increase the stability, transmissibility or the ability to disseminate the agent or toxin becomes 1.7.4.
1.5.5. Does your research alter the host range or tropism of the agent or toxin becomes 1.7.5.
1.5.6. Does your research enhance the susceptibility of a host population to the agent or toxin becomes 1.7.6.
1.5.7. Does your research generate or reconstitute an eradicated or extinct agent or toxin listed in this list becomes 1.7.7.
1.6. Human cell lines, blood, tissue, or other human/nonhuman primate materials becomes 1.8.
1.7. Animal cell lines, blood, tissue, or other materials becomes 1.9.
1.8. Working with Live Animals becomes 1.10.
1.8.1. Are any rDNA materials or recombinant synthetic nucleic acids or recombinant organisms administered to live animals becomes 1.10.1.
1.8.2. Will recombinant synthetic nucleic acids be used for the production of transgenic becomes 1.10.2.
1.8.3. Does your project involve breeding/purchase/transfer of transgenic animals becomes 1.10.3.
1.9. Human Fetal Tissue becomes 1.11.
1.10. Does your research involve any biohazardous chemicals found on this list becomes 1.13.
1.11. Does your research involve any biohazardous chemicals to live animals becomes 1.14.
1.12. Does your research involve radioactive materials, radiation producing devices, or X-ray producing devices becomes 1.15.
1.12.1. List of Isotopes becomes 1.15.1.
1.12.2. Radiation Safety Permit Number becomes 1.15.2.
1.13. Does any projects listed in 1.3 involve the exposure of live animals to radiation becomes 1.16.
1.13.1. Has RSC approval been obtained? Becomes 1.16.1.
New CHLA only sections created for CRISPR and Exposure Control Plans
Staff
Internal Messaging system between staff and committee members
AM Approval Letter template updated to show what "Other" is when listing changes for amendments
New Email Template added for Expedited Reviews
Minutes and Agenda updated so it can be generated automatically
Various miscellaneous bug fixes and enhancements
RSC Changes
Form Changes
Human Use of Radionuclide Details
2. “Dose per Administration” is now “Activity per Administration (mCi)”
3.1. Added definition of standard of care
7. “Pyrogenicity” was removed.
10. “Dose to Primary Critical Organ” is now “Estimated Dose to Primary Critical Organ (include units)”
12. “Dose to Secondary Organ” is now “Estimated Dose to Secondary Critical Organ (include units)”
13. “Dose to Whole Body (TEDE) is now “Estimated Dose to Whole Body (TEDE) (include units)”
15. Critical Organs and 16. Whole Body are removed
Human Use of Radiation Producing Devices Details
Removed duplicate “Fluoroscopic” option in 1. Type of Procedure and modified “Accelerator” to “Linear Accelerator”
Added additional questions relating to Linear Accelerator
2. Locations modified to be checkbox list for locations based on type of procedure selected.
Removed question 7. Total Entrance Skin Exposure per Procedure
Renumbered 8., 9., 10., 11. to become 7., 8., 9., 10. respectively
10.1. Add definition of standard of care
Staff
Internal Messaging system between staff and committee members
Minutes and Agenda updated so it can be generated automatically, added "Action Item Review" to Agenda
