Tag Archives: eGC1

May 2018 Compliance Release 2

New Non-Fiscal Compliance page

The eGC1 Compliance Questions and Explanations pages have been replaced by a new page called Non-Fiscal Compliance. This consolidation provides a more streamlined experience for preparers and reviewers.

Updated questions reflect current institutional needs, with improved clarity in mind.  Links to supporting guidance have been added to assist preparers in understanding the policies and regulations behind each question. You can review the updated questions by visiting this page..

Design improvements make the page easier to navigate and gauge progress toward completion.

human subjects with H S 1 C answered yes

eGC1s that are in routing at the time of this release will display the old compliance questions that existed when the eGC1 was initially routed.

However, any eGC1 that is returned or withdrawn after the release will be reset with the new compliance questions. Answers to the previous questions will no longer display. Plan for additional time to re-complete that page in case a return or withdrawal is necessary.

Zipline and Hoverboard linked to eGC1

Human Subject (Zipline) and Animal Use (Hoverboard) protocols can now be linked to your eGC1. Searching by IRB Application Number or IACUC Protocol Number will allow you to pull in real-time information, reducing manual back-and-forth between systems and improving the accuracy of protocol details in SAGE.

animal use section with hoverboard protocol

Improved Collaboration

Send page link to PI, Reviewers

From any standard eGC1 page (excluding Grant Runner forms), the URL is now a direct link that you can copy and share with others who have access to that eGC1. This will be particularly useful when collaborating with the PI on completing the Non-Fiscal Compliance page.

direct U R L for e G C 1 page

Multi-User Editing (limited)

Currently, only one person can edit an eGC1 at a time. However, the Non-Fiscal Compliance page can now be edited, even while someone else is working in other areas of the eGC1. This will avoid situations where the PI could be blocked from contributing to the Non-Fiscal Compliance page while the administrator is currently editing other areas of the proposal.

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Use this section to provide information about tangible items involved in a project, such as equipment and biological materials. This information helps reviewers understand export control and budgetary implications as well as informing protections that need to be in place for any sharing of tangible items outside UW. Contact Equipment Inventory Office with specific questions about fabricating equipment, or email exports@uw.edu for guidance on export controls.

As with other eGC1 pages, you can partially complete your entries and save the eGC1. You must complete the required fields before you route your eGC1 for approval.

Select Start Section to open the section initially, and then Edit Section to add or update existing data.

E-1. Will equipment be fabricated by the UW on this project?

Answer: Yes or No

Note: if the fabrication is being performed entirely by a non-UW entity (that is, a subcontractor), answer “No”.

E-2. Will the project involve the export of hardware, equipment, specimens, goods, software or monies?

Answer: Yes, No, or Unknown

Note: Answer “No” for personal-use laptops unless the laptop contains any military or space technical data, or if the only international transactions are for travel expenses.

E-2A displays if E-2 = Yes

E-2A. Describe the items/materials

Answer: enter a description

 

E-2B displays if E-2 = Yes

E-2B. Add one or more destination countries

Answer: search for by name, and select the appropriate countries

M-1. Will University-owned biological materials be provided to non-UW parties, including sponsor?

Answer: Yes or No

Note: Materials include (but are not limited to) cell lines, cultures, bacteria, nucleotides, proteins, transgenic animals, pharmaceuticals, or chemicals.

April 2018 SAGE Grant Runner Release

SAGE Grant Runner

NIH Required Fields Added to HSCT

To assist researchers in filling out the Human Subjects & Clinical Trials (HSCT) form, NIH required fields are now indicated with an asterisk and red highlighting. These same fields will have validation messages when the user clicks “Show Form Errors” at the top of the form. All NIH errors and validations will continue to show when the full application is checked by clicking “Check for Errors” in the left navigation of SAGE.

eGC1 Data Sync Improvements with Grant Runner Forms

To help prevent data inconsistencies when multiple browser sessions are open, the data sync between the eGC1 and Grant Runner forms has been improved.  When you make updates to information in the eGC1 that flows through to Grant Runner forms, those updates will now automatically sync with each save/refresh of the eGC1.

Improved Accessibility for  Keyboard and Tab Order Functionality

To meet accessibility standards, all Grant Runner forms are now accessible using keyboard only functionality.  In addition, tab order has been improved to be more logical and intuitive, reducing the number of times the user has to press the tab key.  

Error Messages Enhanced

Question numbers have been added to error messages on all Grant Runner forms. This update will help users quickly identify the specific error within a form.  This will be especially helpful for longer forms such as the new Human Subjects & Clinical Trials form.

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When OSP creates a child Funding Action (FA) for an awarded eGC1, the system will automatically create compliance holds, if appropriate.

The system applies automatic holds to the FA based on the conditions in the following chart.

Compliance Hold Due to
Administrative Support Budget & Fiscal Compliance page: question F2 = Yes
F&A Budget & Fiscal Compliance page: question F1 = Yes
IRB Approval Non-Fiscal Compliance page: question HS-1 = Yes
Cost Share Budget & Fiscal Compliance page: question F3 = Yes
Fed Flow-Through Details page has an Originating Sponsor listed with a Sponsor Type of Federal Government
SFI/FCOI One or more investigators on the PI, Personnel, & Organizations page has an SFI value of Yes or Unknown
Export Control Non-Fiscal Compliance page: if Yes for any one of questions E-2, D-1, D-2, D-3, D-4.
IACUC Non-Fiscal Compliance page: question AU-1 = Yes
PHS Training One or more investigators on the PI, Personnel, & Organizations of a PHS-sponsored eGC1 has either not done the FCOI training or the training has expired.

 

 

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Use this section to indicate if and how specific types of information and technologies will be involved in the project so that reviewers can determine if special guidelines or restrictions apply. Contact exports@uw.edu for guidance on export control limitations related to sharing of data and technology. For information about the Washington Innovation Advantage Program (WIAP), visit the CoMotion site or contact osp@uw.edu with further questions.

As with other eGC1 pages, you can partially complete your entries and save the eGC1. You must complete the required fields before you route your eGC1 for approval.

Select Start Section to open the section initially, and then Edit Section to add or update existing data.

D-1. Does this project involve any of the following?

Answer: Check all that apply

  • Proprietary Information
  • Export Controlled/Controlled Unclassified Information
  • Classified Information
  • Other Sensitive Information (Excludes personal or patient information)
  • None of the above

You must make at least one selection. If “None of the above” is selected, the system will clear any other boxes that were checked.

D1-A displays if for D-1 you select any value other than “None of the above”

D-1A.  Will this information be shared with foreign nationals in the United States or abroad (including UW faculty, staff, or students)?

Answer: Yes or No

Note: U.S. Permanent Residents are not considered foreign nationals. The actual country of citizenship/residency of foreign nationals is not required at this time.

D1-B displays if for D-1 you select “Other Sensitive Information (Excludes personal or patient information)”

D1-B. Please describe the other sensitive information

D-2. Is this project intended to assist any foreign country’s military or space activities?

Answer: Yes or No

D-2A displays if D-2 = Yes

D-2A. Please describe.

D-3. As far as you know, will the sponsor require approval prior to foreign national participation or prior to publication of the research results of this project?

Answer: Yes or No

D-4. Will the project involve travel to or collaboration with a person or entity in a sanctioned country (e.g., Cuba, Iran, North Korea, Sudan, Syria)?

Answer: Yes or No

Question T-1 displays if the Sponsor Type and/or Originating Sponsor Type (as indicated on the Details page) is one of the following:

  • Private Industry
  • Private School, College, University
  • Foreign Private Industry

T-1. Does the Sponsor wish to obtain an upfront commercial license to Project Intellectual Property (IP) based on the pricing under the Washington Innovation Advantage Program (WIAP)?

Answer: Yes, No, or Unknown

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Use this section to provide information about human subject involvement and approvals for the project to help reviewers determine compliance with UW and sponsor requirements. Contact the Human Subjects Division with questions.

As with other eGC1 pages, you can partially complete your entries and save the eGC1. You must complete the required fields before you route your eGC1 for approval.

Select Start Section to open the section initially, and then Edit Section to add or update existing data.

Human Subjects Questions:

HS-1. Will the project involve interaction with Human Subjects, or identifiable data or specimens from human subjects?
Answer: Yes or No.  An answer is required.

HS-1A displays if HS-1 = Yes

HS-1A. Delayed Onset: Will IRB application submission be delayed until after award because you will (1) identify and develop new protocols that will be supported by the award or (2) complete other research described in the proposal that is necessary before the human subjects research can be fully planned.

Answer: Yes or No

HS-1B displays if HS-1 = Yes

HS-1B. IRB Approval Pending:  Will you need to submit a new IRB application, modify an existing IRB application, or are awaiting approval of a current IRB application for the human subject research in this project?

Answer: Yes or No

A table for IRB Application Details displays if HS-1 = Yes

Note: If HS-1 = Yes, and HS-1A = No (Delayed Onset), and HS-1B = No (IRB Approval Pending), then you must include at least one IRB application. See details below on how to add an IRB Application.

HS-1C displays if HS-1 = Yes AND Sponsored Program Activity Type (Details page) is “Clinical Trial – Federal Sponsors” or “Clinical Trial – Non-Federal Sponsors”

HS-1C. CRBB Involvement. Will the project involve use of UW Medicine clinical services or clinical space as a site of patient care, or include medical treatment of a patient by a UW Physicians provider?

Answer: Yes or No

CRBB (Clinical Research Budget & Billing) Note: If any of the following statements apply to this proposed work, mark Yes, even if the research involves only usual patient care items or the study budget will not be charged.

  • Some of the proposed work will be conducted in a UW Medicine clinical setting. See CRBB Coverage Analysis Checklist, Section II, Sites of Practice, for a complete list of sites. Studies using Seattle Cancer Care Alliance locations should use the SRAMP access point when submitting to CRBB.
  • The study involves one or more clinical procedures at one of these sites, such as use of a patient examination room, blood draws, imaging, clinical lab tests, administration of a research medication, or procedures.
  • Payment of physician professional fees for clinical services from a UW-affiliated or Northwest Hospital physician is required, separate from the salaried research personnel effort reflected in the budget.

Contact CRBB at crbb@uw.edu or 206-543-7774 for assistance.

HS-2. Stem Cells. Will this research involve the use and/or creation of human embryonic stem cells?
Answer: Yes or No   An answer is required.

Add IRB Application

Start by selecting Add IRB Application. A dialog box will open where you can choose how you enter your data.

Search Zipline

You can use the blue “X” in the upper, right-hand corner to close the dialog and return to the Human Subjects section without saving any data.

The following image shows the initial dialog box.

add i r b dialog

Enter all or part of the Zipline Application Number in the search box. The system will search for all applications that contain the entered numbers in the application number field. The results list will display below the search box, as shown in the following image.

add i r b search results

Click on the appropriate study in the results list to select it. The study data will display in the dialog window, as shown in the following image.

i r b study details

Use the Save button in the lower, right-hand corner to add the study data, and return to the Human Subjects section.

Enter Manually

You have the option to add IRB Application information manually.  Select Enter Manually in the dialog, then add the requested information.

    • Reviewing IRB Name
    • IRB Application PI
    • IRB Application Number
  • Approval Date
  • Expire Date
  • IRB Application Title

Select Save to return to the Human Subjects section.

Note: All of the fields are required prior to eGC1 completion.

The following image shows the manual entry screen.

add i r b manually dialog

IRB Application Details section

Your data will appear as an expandable row of a table in the IRB Application Details section of the page.
The table row shows the follow data fields:

  • IRB Application Number
  • Reviewing IRB Name
  • IRB Application PI
  • Approval Date
  • Expiration Date

You can edit or delete it using the icons (pencil, trash can) in the Actions column at the far right of the table row.
Use the chevron to the left of the row to expand the data shown. The additional data displayed includes:

  • IRB Application Title
  • Zipline Application Number
  • Zipline Status
  • Approved Funding Sources

The following image shows an expanded table entry.

i r b table entry expanded

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Use this section to provide information about the use of vertebrate animals in the project to allow reviewers to determine compliance with UW and sponsor requirements. If you have questions regarding the use of Vertebrate Animals, please contact the Office of Animal Welfare.

As with other eGC1 pages, you can partially complete your entries and save the eGC1. You must complete the required fields before you route your eGC1 for approval.

Select Start Section to open the section initially, and then Edit Section to add or update existing data.

AU-1. Will the project involve the use of vertebrate animals?

Answer: Yes or No

A table for Animal Use Protocols and an Add Protocol button display if AU-1 = Yes

Note: If AU-1 = Yes, then you must include at least one protocol.

Add Protocol

You can add a protocol in three ways. Start by selecting Add Protocol. By default, the UW Protocol choice displays. Select the appropriate protocol type link from there.

Each type is explained below.

UW Protocol

Use this to search Hoverboard and import your data. Start by entering at least 3 digits of your protocol number. The search will return any items that contain the digits you enter. Click in the results list to select the appropriate item.  The following image shows a results list after search for “234”.

add protocol search results

When you select a protocol from the results list, the following data displays in the dialog window:

  • Protocol Title
  • Protocol PI
  • Primate Center Involved – Yes or No
  • Expiration Date

Select Next to continue the process. The dialog will display the question “Does the protocol require an amendment?”  Answer Yes or No.

Select Save to return to the Animal Use section.

Note: If the value for Primate Center Involved is Yes, the Primate Center will be added to the approval flow as an Approver.

The following image show the amendment question in the dialog window, with Yes selected.

add protocol amendment question

External Protocol

Select this choice in the Add Protocol dialog to enter an External Protocol. Select the appropriate institution from the drop-down menu.

The choices are:

  • Fred Hutchinson Cancer Research Center (FHCRC)
  • VA Puget Sound Health Care System (VAPSHCS)
  • Seattle Children’s Research Institute (SCRI)
  • Benaroya Research Institute of Virginia Mason (BRI)
  • Center for Infectious Disease Research (CIDR)
  • Allen Institute
  • Add a New Institute

The following image shows the initial screen with the drop-down menu expanded.

add external protocol list

When you select one of the existing institutions from the menu, its details will display. These fields are

  • Institution Assurance Number
  • Institution Country
  • Institution City

You can find more information about assurance numbers on these NIH web pages:

The following image shows the details for Fred Hutchinson Cancer Research Center (FHCRC).

external protocol details

Select Next to enter your Protocol Number and the Expiration Date.

The following image shows this step, with some example data entered.

add protocol details

Select Save to complete your entry.  You can save a partial entry. It must be complete prior to routing your application.

The following image shows the expanded table row from this entry on the compliance summary page.

protocol table entry example

New Protocol

If you will be establishing a new protocol, select that option from the initial Add Protocol dialog box. You just need to answer yes or no to the question “Will the Primate Center be involved in the research?”

If you select Yes, the Primate Center will be added to the approval flow as an Approver.

The following image shows the New Protocol dialog with the Primate Center question.

new protocol

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Use this section indicate whether EH&S agents or activities are going to be used during the project. Responses to the EH&S section provide additional guidance on regulations and approvals needed to perform the work. Contact Environmental Health & Safety with questions.

As with other eGC1 pages, you can partially complete your entries and save the eGC1. You must complete the required fields before you route your eGC1 for approval.

Select Start Section to open the section initially, and then Edit Section to add or update existing data.

EHS-1. Will this project involve any of the following?

Answer: Check all that apply

  • Biohazards
  • Select Agents and Toxins
  • Radioactive Materials
  • SCUBA Diving
  • Chemical Thresholds (toxic, unstable, explosive)
  • None of the Above

You must make at least one selection. If “None of the Above” is selected, the system will clear  any other boxes that were checked.

Additional information will display when a box is selected.

  • Biohazards: Biological Use Authorization from the UW Institutional Biosafety Committee is required as defined on the EH&S webpage. Please note that some categories of research require BUA prior to initiation. The BUA application submission deadlines are also posted on this website.
  • Select Agents and Toxins: EH&S approval of this eGC-1 is required due to federal regulations. EH&S will work with the PI to obtain necessary federal clearances, approvals, and training. Documentation of due diligence is required for any transfer of Select Toxins in any amount. Some Select Agent and Select Toxin research is subject to review by the Dual Use Research of Concern (DURC) Institutional Review Entity (IRE). See the EH&S website for information about Select Agents and Select Toxins, Select Toxin Due Diligence, and DURC.
  • Radioactive Materials: Approval of this application will be contingent on whether or not a Radiation Use Authorization (RUA), issued to the Principal Investigator (PI), sufficiently covers the proposed radioactive material work.
  • SCUBA Diving: Anyone diving under the University of Washington’s auspices must have current certification as a University of Washington Scientific Diver and adhere to the standards set forth in the UW’s Diving Safety Manual. EH&S will contact you to assist in meeting Diving Safety Program requirements prior to diving. For more information, please see: https://www.ehs.washington.edu/research-lab/diving-safety-program
  • Chemical Thresholds (toxic, unstable, explosive): EH&S will contact you for planning assistance as fire department requirements may not allow these quantities in your space or may require building modifications.
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Campus research teams and related central offices use the SAGE Suite electronic research administration system to manage application proposals and related items. The suite is comprised of three components that access the shared SAGE Suite database.

  • SAGE: System to Administer Grants Electronically – used by campus researchers and administrators
  • SPAERC: Sponsored Projects Administration & Electronic Research Compliance – used by the Office of Sponsored Programs (OSP)
  • SERA: System for Electronic Research Accounting – used by Grants and Contract Accounting (GCA)
  • FIDS: Financial Interest Disclosure System – used by researchers designated as investigators

The following set of tables gives a high-level overview of who uses each of the different components, and describes the possible actions and the why and/or when.

SAGE: System to Administer Grants Electronically

WHO: Campus research administrators, Principal Investigators, campus reviewers, compliance reviewers

ACTION WHY / WHEN
Create SAGE Budgets Centralizes data gathering for salaries, benefits, F&A rates. It can be linked to an application, which automatically populates the eGC1 budget page. Any changes to the budget will update in real time when the eGC1 Budget page is viewed.
Create applications (standard or Grant Runner) Required for all sponsored research. The Grant Runner version includes the sponsor forms for NIH, and is submitted system-to-system by OSP.

The application (eGC1 pages) is, in effect, an approvals routing cover letter for the proposal. It is used only by UW and does not go to the sponsor.

Approve routing applications Used by the Principal Investigator, Multiple-PI, Application PI, academic reviewers (division, department, dean) and compliance reviewers (human subjects, animal use, EH&S, etc.) to view and approve the application. At each approval, a PDF snapshot of the application is captured and attached to the eGC1 on the Approvals History & Comments page.

Administrators and reviewers have the option to add other reviewers (as individuals or a group) to the approval flow. These are referred to as “ad hoc” reviewers (approvers or watchers).

Request an advance budget number for awards Used when the research proposal is being awarded by the sponsor, but the actual award has not yet arrived. It requests GCA to set up a budget account in the financial system so the research team can start spending the award money. When the preparer completes it in SAGE, GCA will be able to view and process it in SERA.

Applications, by default, are not eligible for an advance.  The eGC1 preparer must use the Advanced Budget Eligibility tool to request that OSP mark the application as eligible.

Create subaward requests for awarded applications Used when a research proposal has been awarded, and part of the award needs to go to the subrecipients (subcontractors) that the research team will be collaborating with. For a new award, a “new” subaward request (SA) is created along with its parent subaward (SC).  For an ongoing award, a “modification” request would be created within the existing subaward (SC).

 

SPAERC: Sponsored Projects Administration & Electronic Research Compliance

WHO: Office of Sponsored Programs (OSP)

ACTION WHY / WHEN
Review and approve applications OSP reviews the information on the eGC1, such as the sponsor proposal information and compliance questions, after all campus reviewers have approved.  When OSP approves the application, they place it into a new or existing Cycle.
Add Approved applications to a Cycle A Cycle holds a “competing segment” for a research team/project/sponsor combination. It’s a container to keep applications, their related advances, funding actions, admin actions, and subawards together. One cycle can be “related” to another, so that more than one segment is associated.

A Cycle is automatically deleted when the last item in it is removed.

Create various types of Administrative Actions as needed Administrative Actions document various related agreements, adjustments and/or changes, and the finalization of a research project. These actions all appear in the project’s cycle, associated to their appropriate parent item.

Note that all actions (including Funding Actions) start as “unidentified” ones, with a prefix of AA. They are then converted to the specific type needed.

  • Non-Award Agreement (NAA) records a generic agreement not pertaining to funding.
  • Pre-Award Notification (PAN) records a change to the proposed project before the sponsor awards funding.
  • Post-Award Change (PAC) records changes to the project after the sponsor awards the funding.
  • Close Out (CO) records the tracked activities to terminate a project upon completion of the research.
Create Funding Actions (FA) for awards When an application is awarded by the sponsor, OSP creates a Funding Action as a child of the application. Depending on answers to certain compliance questions, there may be automatic “holds” applied.

Once the FA is completed (and all holds are cleared), it is trasmitted to SERA to establish a budget in the financial system (if not already done via Advance Request).

Process subawards OSP reviews the subaward requests, and negotiates the contract with the subrecipient. The request moves through several statuses until, when the agreement is “fully executed” the request becomes Active. It is automatically “Expired” once the End Date is passed.

SCs and FAs can have a many-to-many relationship. The system enforces that all related FAs and SCs must be within the same cycle.

SERA: System for Electronic Research Accounting

WHO: Grant & Contract Accounting (GCA)

ACTION WHY / WHEN
Process Advance Budget Number Requests Received from the research team, this allows the team to spend award money before the actual award arrives. GCA adds a budget number to the ADV and sets up that budget in the financial system. As part of completing the ADV, the system sends a notification to the requesters.
Process Funding Actions Received from OSP.  GCA adds a budget number, if needed, and sets up the budget in UW financial system. As part of completing the FA, the system sends a notification to the requesters, and the first-level reviewers for the organization code receiving funding.
Process Post-Award Changes Received from OSP. Not all types of PACs are sent on to GCA. As part of completing the PAC, the system sends a notification to the requesters.
Create “Other” items Created as needed for various budgetary processes. These items only appear in SERA.

FIDS: Financial Interest Disclosure System

WHO: Any research personnel designated as an “Investigator” on the PI, Personnel, & Organizations page of the eGC1.

ACTION WHY / WHEN
Create a Financial Interest Disclosure for an eGC1

or

Complete an Annual Update disclosure

Investigators are required to disclose any significant financial interests (SFI) such as salary, equity, sponsored travel, etc., that might, or might appear to, bias their research.

An investigator must complete a disclosure for each eGC1, whether or not there are SFI that apply, before the proposal can be marked as Ready-to-Submit = Yes.

The disclosures are reviewed by the SFI Reviewer, in OR Central, who determines if there is a potential for a Financial Conflict of Interest (FCOI).  The review occurs at the time of award (just-in-time).

Annual Updates: All investigators are required to review and update their SFI at least once a year. The “year” is calculated from the date of the last disclosure created. Investigators are notified by email 45 days prior, and again at 15 days prior, to the end of that year’s time.

Full details on using FIDS  can be found in its User Guide.

Note: only a UW NetID is needed to access FIDS.

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NOTE:  To enable improved collaboration, you can send a direct link to the PI and Reviewers

From any standard eGC1 page (excluding Grant Runner forms), the URL is now a direct link that you can copy and share with others who have access to that eGC1. This will be particularly useful when collaborating with the PI on completing the Non-Fiscal Compliance page.

direct U R L for e G C 1 page

Non-Fiscal Compliance Overview

Use this page to provide details related to non-fiscal compliance information. These details will

  • Identify special considerations in this application and bring them to the attention of reviewers
  • Provide information necessary for the UW approval process
  • Provide information that may help campus unit and central office approvers review your application quickly
  • Facilitate proposal review and central office review at time of award

There are five sections on this summary page and each is covered in more detail in its own article.

  • Human Subjects
  • Animal Use
  • Environmental Health & Safety
  • Equipment & Materials
  • Data & Technology

NOTE: If you are viewing an older application, you will see the questions you answered at that time, displayed in read-only mode and organized into the sections listed above.

On this summary page, select “Start Section” to open a section for data entry.

Once you have started a section, when you return to the summary page, you will see a link to Edit Section. In addition, an Expand + link will display on the right of the section. Select it to open the section and view the data in read-only mode. The link will change to Collapse – when the section is expanded.

This page also has Expand All and Collapse All links above the first section, on the right side of the page. Use the Expand All link to open all of the sections in read-only mode. Collapse All will close all of the sections.

In the following image, the second section, Animal Use, shows the Edit Section link. The third section, Environmental Health & Safety, shows a section in the expanded, read-only view.

non-fiscal compliance summary page