Administrative Change Updates


In this page:


The online Administrative Changes section will allow you submit requests for each type of administrative change without having to submit an Amendment. Once a change that requires approval is submitted, the IACP office will receive notice.

  • One, or multiple administrative changes can be made at once. 
  • Administrative Changes can be initiated for all approved application. 
  • If a protocol has expired, a progress report must be processed and approved before the Administrative Changes section becomes available.
  • If an Administrative Change is pending approval, an Amendment can not be initiated.

Where do I begin?

  1. Log into O.R.C.A.
  2. Dashboard: Locate section, Your Protocols.

  1. Click on the Protocol # link.
  2. You will be taken to the Protocol Info page.

  3. Click the Action button.
  4. Click Administrative Change.


Study Personnel 

The Study Personnel tab lists the Study Team for the approved protocol. An actions column with action buttons are available for each study team member.

  • Add individuals to your protocol
  • Edit individuals
  • Delete individuals
  • Clone individuals

Edit Study Team Members

From the Study Personnel tab, locate the edit icon for the individual you would like to edit. 

  1. Click the Edit icon
  2. Make edits in the team member's profile tab
    1. All fields can be updated
    2. Institution; Department; Job Title will be pulled in from that individuals employee record
    3. Point of Contact & Emergency Contact may be edited at this time
  3. Click the Save button once all edits have been made
  4. Review & Submit updates to indicate an Administrative Change was made
  5. The team member whose profile was edited will now have a blue background indicating a change was made to an already exiting study team member
  6. Click the Review & Submit tab once all administrative changes are completed
  7. Review the Study Personnel summary and click the Submit Admin Changes button

Add Study Team Members

From the page, Administrative, tab Study Personnel,

  1. Click the +Add button and complete the Profile tab for the new individual.
  2. Select Person: 
    1. Begin typing the last name of the person you will add to your protocol. A drop list of individuals will display. 
    2. Select the individual. That individual is now listed in the Persons Selected field. 
    3. Institution, Department and Job Title will populate for most individuals.

  3. Performing activities at: 
    1. The site locations (selected on the Reviewing Committee page) will display. 
    2. Select the location where this individual will be performing activities at if there is more than one site for this protocol.

  4. Engaged in Experimental manipulations: If the person selected will be performing procedures/working with animals, select Yes. If the individual will not be engaged in experimental manipulations, skip to #8. If Yes, is selected, a sub-set of fields will display:

    All personnel conducting procedures on the species being maintained or used must be appropriately qualified and trained in those procedures §. 2.31 (d)(1)(viii); PHS IV.C.I.f.



    1. Site PI at: If applicable, select the site that this individual will act as the local PI.
    2. Duties on protocol: A drop down list will display. Select all duties that are applicable to the person for this protocol.
      1. Directing Team - Directing the research team members and assessing compliance with study protocol. Directing the study site PI(s) at other locations, if applicable
      2. Data Safety/Monitoring - Determining significance of subject safety indicators (e.g. adverse events) . Determining the significance of protocol deviations or violations. Ensuring the integrity of the data.
      3. Specialized skills - Performing a high risk procedure requiring a specialized skill or expertise
        1. If Specialized skills is selected, complete the List skills and training/experience table.
      4. Interaction Activities - Administering intervention, performing study procedures, obtaining laboratory specimens, investigational product accountability
      5. Shipping - Specimen shipping
    3. Efforts on behalf of: Indicate which organization (e.g., the HSC or one of our affiliates) employs this person.  If an individual is affiliated with more than one organization, select the one most applicable to this protocol.  For study team members who are not employed by or agents of the HSC or one of our affiliates, select Investigator Agreement.  An Individual Investigator Agreement (IIA) extends the Health Science Center's federal assurance to conduct research to the individual investigator.  Given the importance of such a decision, IIA's must be approved by the PI's Department Chair.  Individual investigator agreements can not be used to cover researchers who are employed by an assured institution.
    4. Affiliation: If applicable, select if the person is a Student, Resident, or Fellow.

  5. Rights on protocol: A drop down list will display the option, Delegate. 
    1. Delegate - A delegate can: submit administrative requests on behalf of PI, submit animal transfer requests on behalf of PI, complete progress report details (but cannot submit), complete new application details (but cannot submit).
      1. If a person is Not Engaged and is not a Delegate, that individual will not have access to the protocol summary.

  6. Point of Contact: If applicable, select Yes as Point of Contact for this protocol.
    1. (warning) If the person's Cell, Home Phone or Alt Email is blank, the PI or Delegate can update this field. Once updated, an edit can only be made by the Individual via their User Profile in O.R.C.A

  7. Emergency Contact: If applicable, select Yes as Emergency Contact for this protocol. This information is used by the DLAR staff and should be kept current. 
      1. (warning) If the person's Cell, Home Phone or Alt Email is blank, the PI or Delegate can update this field. Once updated, an edit can only made by the Individual via their User Profile in O.R.C.A
    • If a Point of Contact or Emergency Contact is not selected, the PI will be the default Point of Contact and Emergency Contact to the protocol.
  8. Click Save

    You will be taken back to the All Sites tab. Here you will see the person(s) you have added with a green highlight.

  9. Training Record
    1. Click the graduation cap icon. A window will display records of information from CITI and the Knowledge Center for the individual.


To add additional team members, repeat the above steps, or Clone a record. Continue to Clone for more information.

Clone Study Team Members

As you add individuals to your protocol, each individual will have an Actions column allowing you to edit, delete or clone. Cloning will allow you to Clone a study team member's protocol profile information. Once cloned, you will be able to make edits.

  1. Click the Clone icon next to the study team member you want to clone.
  2. From the tab, Profile, use Persons select drop down to search for a person to add to your team.
  3. Update the required fields, if needed. Follow steps 3-9 in Add Study Team Members
  4. Click Save.

The person is now listed as a study team member for your protocol.




Co-PI

A Co-PI is a local IACUC practice and is not required for approval. One Co-PI may be assigned to a protocol. The Co-PI assumes the same responsibilities as the PI. These responsibilities include management of the protocol, submission of reports and requests typically reserved for the PI such as amendments, and providing sources of funding.

Remove a Co-PI

  1. From the Co-PI tab, click Remove
     
  2. Click Save
  3. Click the Review & Submit tab
  4. Click Submit Admin Changes

Assign a Co-PI

If a Co-PI is already assigned to a protocol, select Replace.

The Co-PI drop down will list all approved  study team members. To assign a Co-PI the individual must first be listed as a Study Team Member.

  1. Click the drop down option
  2. Select a team member
  3. Co-PI Justification -  include a justification for sharing the PI responsibilities.

        (star) For example: The PI will be out of the office for a specific period of time. 




Grants / Funding Sources

The funding sources tab will allow you to associate your funding sources to a protocol outside of an Amendment and after a New application has been approved.

Funding source options that will display are those that are managed by the Office of Sponsored Programs. If a grant or funding source is not managed by the Office of Sponsored Programs, but you would like to associate it to your protocol, you have the opportunity to Add a Grant and link it to your protocol.

  • If the grant/funding source has not yet been approved by the Office of Sponsored Programs, it will not be listed.
  • If Add Grant is used, the Grants/Funding Source will show in the PI Grants tab, section Your Grants.
  • Funding sources in the Your Grants section can be edited.

Link a Grant/Funding Sources 

  1. Click the Funding Sources tab. You will have 3 tabs: PI Grants; Co-PI Grants and Add Grant. Initiate one of the two options below:

Link an existing grant 

From either PI Grants or Co-PI Grants tabs:

    1. Locate the Grant.
    2. Click the Select box for the grant/funding source you are linking.
    3. Click Save.
    4. Click the Review & Submit tab.
    5. Click Submit Admin Changes.

Add a Grant

Click the Add Grant tab:

    1. If the grant you wish to add is not managed by the Office of Sponsored Programs and is not listed:
    2. Click Add Grant

    3. Complete the form

    4. Click Save

    5. The grant will be listed in a section titled, Your Grants.

    6. Click the Select box for the grant/funding source you are linking.

    7. Save your information

    8. Click the Review & Submit tab.

    9. Click Submit Admin Changes.

.

Funding Source Unknown

 If you are unsure of your protocol's funding source, there is an option to indicate this information.

  1. Click the Funding Sources tab. 
  2. Click, the option, Funding Source Unknown. 
  3. Click the Review & Submit tab.
  4. Click Submit Admin Changes.

If you have chosen Funding Source Unknown, in the IACUC Protocol Information page, the Funding Source section will display the below:

Funding Requiring review

When a funding source is Federally sponsored it will require review by the IACP office. Once submitted, you will see a blue icon In-Progress next to the grant.  Once approved, you will no longer see the section, 

In-Progress|Submitted Funding Source Selections. The grant's select column will include a check mark after approval indicating the funding source is attached to the protocol.


In-Progress|Submitted Funding Source Selections

IACP approval is not required

At the time you submit your administrative changes for funding via the Review & Submit tab, if a funding source does not require the approval of the IACP office, you will receive a message like below.



Occupational Health & Safety

Occupational health and safety of personnel is an essential part of the overall program of animal care and use.  Use this section to identify potential hazards in the work environment specific to this protocol.  An effective occupational health program requires coordination among the researcher, the Animal Care Program (DLAR, IACP & IACUC), the environmental health and safety program, occupational health services and administration.

Common hazards are provided however there may be others not specifically listed that should be noted in the "other potential hazard" item.

  1. Click the Occupational Health & Safety tab.
  2. Respond to the questions presented that are related to Protocol Related Hazards and Training, Medical Surveillance and Follow-up 

  3. Click Save.
  4. Click the Review & Submit tab.
  5. Click Submit Admin Changes.




Review and Submit

  • Once an administrative change is submitted to the IACP office, the submitted request is locked until it is either approved or denied.
  • Not all Administrative Changes require IACP approval. 
    • For Administrative Changes that do not require approval a Success message will display indicating the changes were auto-approved.
    • For Administrative Changes that do require IACP approval, once you have made edits and saved, the Review and Submit tab will display your requested items. From here, you will submit your request(s) and the IACP office will be notified.


Status

Once your Administrative Changes are submitted, the Dashboard and Protocol History will provide information on the status of the Administrative Change.

Submitted Items

Form the Dashboard, the Submitted Items section there is a tab for Administrative Changes. In this tab you will see a line item for the Administrative Change you submitted.

History

To access the protocol's history:

  1. Navigate to your Dashboard
  2. Locate the Your Protocols section
  3. Locate your protocol and click the protocol number hyperlink 
  4. You are now at the IACUC Protocol Information page


  5. Click the Protocol History button. A list of transactions for the protocol will display. Once the administrative changes are processed, the history will display the decision.