General Discussions

Colleagues,

Periodically I need to add a document to an approved protocol.  The document could be a training record, an MOU, a note to file or something else which wouldn't require the usual amendment process to include it as part of the protocol e-file.  But because I don't know of another way, that is what I have been doing.  Today the circumstance presented itself again and I decided to ask the community.  Does anyone have a better way, where the PI doesn't have to be involved and submit an amendment?

If not, I'm going to add this to the "ideas" page.

thanks,
Bruce

This is a good question, @Bruce Kennedy, and I can see the benefit of looking for a more direct route that doesn't have to involve the PI. Let me ask around and see if I can find an answer one way or another for you.

Simon​

------------------------------
Simon Helton
He/him
Community Manager
Cayuse
Portland OR
5416198827
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Original Message:
Sent: 05-24-2021 13:27
From: Bruce Kennedy
Subject: Animal Oversight - adding documents to approved protocols

Colleagues,

Periodically I need to add a document to an approved protocol.  The document could be a training record, an MOU, a note to file or something else which wouldn't require the usual amendment process to include it as part of the protocol e-file.  But because I don't know of another way, that is what I have been doing.  Today the circumstance presented itself again and I decided to ask the community.  Does anyone have a better way, where the PI doesn't have to be involved and submit an amendment?

If not, I'm going to add this to the "ideas" page.

thanks,
Bruce

------------------------------
Bruce W Kennedy
IACUC Administrator
Chapman University
Irvine CA
(714) 628-2844
------------------------------

Hi Bruce,
I hope you are doing well.  This is an excellent question.  At this time, the approved protocol is locked and we don't have a way to attach additional documents to the efile outside of the protocol form.

It is possible to create an amendment from the IACUC Office role, attach the document, and then submit the amendment without the PI being involved.  One tricky aspect of this is that the Submit page is hidden from the IACUC Office role on the Table of Contents (TOC).  If you go to the page just above attachments and then use the Next button to move forward, you can submit on behalf of the PI.

Have a fantastic week,
Odessa

------------------------------
Odessa Reilly
Services Senior Professional & Consultant
Cayuse
Portland OR
(503) 297-2108
------------------------------

Original Message:
Sent: 05-24-2021 13:27
From: Bruce Kennedy
Subject: Animal Oversight - adding documents to approved protocols

Colleagues,

Periodically I need to add a document to an approved protocol.  The document could be a training record, an MOU, a note to file or something else which wouldn't require the usual amendment process to include it as part of the protocol e-file.  But because I don't know of another way, that is what I have been doing.  Today the circumstance presented itself again and I decided to ask the community.  Does anyone have a better way, where the PI doesn't have to be involved and submit an amendment?

If not, I'm going to add this to the "ideas" page.

thanks,
Bruce

------------------------------
Bruce W Kennedy
IACUC Administrator
Chapman University
Irvine CA
(714) 628-2844
------------------------------

One more thought on the concept of an administrative amendment.  The system will need to record a change to the form in order to submit it.  Just attaching a file will not trigger the change.  My recommendation would be to modify a text field in the form to state that an attachment is being added.  This should allow for the IACUC Office to submit the amendment.

------------------------------
Odessa Reilly
Services Senior Professional & Consultant
Cayuse
Portland OR
(503) 297-2108
------------------------------

Original Message:
Sent: 05-24-2021 17:42
From: Odessa Reilly
Subject: Animal Oversight - adding documents to approved protocols

Hi Bruce, 
I hope you are doing well.  This is an excellent question.  At this time, the approved protocol is locked and we don't have a way to attach additional documents to the efile outside of the protocol form.  

It is possible to create an amendment from the IACUC Office role, attach the document, and then submit the amendment without the PI being involved.  One tricky aspect of this is that the Submit page is hidden from the IACUC Office role on the Table of Contents (TOC).  If you go to the page just above attachments and then use the Next button to move forward, you can submit on behalf of the PI.  

Have a fantastic week, 
Odessa

------------------------------
Odessa Reilly
Services Senior Professional & Consultant
Cayuse
Portland OR
(503) 297-2108

Original Message:
Sent: 05-24-2021 13:27
From: Bruce Kennedy
Subject: Animal Oversight - adding documents to approved protocols

Colleagues,

Periodically I need to add a document to an approved protocol.  The document could be a training record, an MOU, a note to file or something else which wouldn't require the usual amendment process to include it as part of the protocol e-file.  But because I don't know of another way, that is what I have been doing.  Today the circumstance presented itself again and I decided to ask the community.  Does anyone have a better way, where the PI doesn't have to be involved and submit an amendment?

If not, I'm going to add this to the "ideas" page.

thanks,
Bruce

------------------------------
Bruce W Kennedy
IACUC Administrator
Chapman University
Irvine CA
(714) 628-2844
------------------------------

Hi Bruce,

I've done as Odessa recommends.  Usually the section change that i make to enable the submission is to just add a space at the end of a text field--I don't directly reference the attachment within the protocol, other than in the Amendment Reason box.  However, it's not a bad idea to do so :)

Another point at which you can add an attachment is during a protocol or amendment review; it seems that any reviewer can affix an attachment to the Attachments section at that time.  Usually one of the reviewer comments will indicate to the PI that this has been done and why (e.g., we want to remind you of our policy on topic X and have attached it; please revise procedure Z to comply...).  So even if a protocol is already tied up with a PI-initiated action, you still have the ability to add your attachment during the review process.

But also if the PI is taking a while to respond to reviewer comments and you are really itching to add your attachment to their protocol and fear you might forget by the time it comes back to you, you can also add yourself to the PI''s group thru Site Admin, then switch to the Researcher role and select that PI, and you can go in and add to the Attachments section.

So many options available!

I hope you've got good weather your way to enjoy today :)

Cheers,
Cheryl

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Cheryl Cheney, CPIA
IACUC Coordinator/Compliance Specialist
Biogen
Cambridge, MA
------------------------------

Original Message:
Sent: 05-24-2021 21:38
From: Odessa Reilly
Subject: Animal Oversight - adding documents to approved protocols

One more thought on the concept of an administrative amendment.  The system will need to record a change to the form in order to submit it.  Just attaching a file will not trigger the change.  My recommendation would be to modify a text field in the form to state that an attachment is being added.  This should allow for the IACUC Office to submit the amendment.

------------------------------
Odessa Reilly
Services Senior Professional & Consultant
Cayuse
Portland OR
(503) 297-2108

Original Message:
Sent: 05-24-2021 17:42
From: Odessa Reilly
Subject: Animal Oversight - adding documents to approved protocols

Hi Bruce, 
I hope you are doing well.  This is an excellent question.  At this time, the approved protocol is locked and we don't have a way to attach additional documents to the efile outside of the protocol form.  

It is possible to create an amendment from the IACUC Office role, attach the document, and then submit the amendment without the PI being involved.  One tricky aspect of this is that the Submit page is hidden from the IACUC Office role on the Table of Contents (TOC).  If you go to the page just above attachments and then use the Next button to move forward, you can submit on behalf of the PI.  

Have a fantastic week, 
Odessa

------------------------------
Odessa Reilly
Services Senior Professional & Consultant
Cayuse
Portland OR
(503) 297-2108

Original Message:
Sent: 05-24-2021 13:27
From: Bruce Kennedy
Subject: Animal Oversight - adding documents to approved protocols

Colleagues,

Periodically I need to add a document to an approved protocol.  The document could be a training record, an MOU, a note to file or something else which wouldn't require the usual amendment process to include it as part of the protocol e-file.  But because I don't know of another way, that is what I have been doing.  Today the circumstance presented itself again and I decided to ask the community.  Does anyone have a better way, where the PI doesn't have to be involved and submit an amendment?

If not, I'm going to add this to the "ideas" page.

thanks,
Bruce

------------------------------
Bruce W Kennedy
IACUC Administrator
Chapman University
Irvine CA
(714) 628-2844
------------------------------

Odessa and Cheryl,

Thanks much for the responses.  Actually, I should label them resolutions, since I was able to resolve this challenge.

I had been doing as Cheryl suggests to be "on" the PI's research team, where I could write the amendment and attach documents.  I still had to have the PI push the actual submission, however.  Using Odessa's workaround (more on that later), I completed the task in less than 5 minutes.

At first, it didn't work, because I had not created an actual change.  The system needs to see something different and register that as the amendment.  During implementation, Odessa and I created a textbox to gather random notes and thoughts.  This turned out to be perfect as the place to document what I would call an administrative amendment.
So, I wrote into the box the details of the admin amendment, which was much the same verbiage as the reason for the amendment.  That was recognized as the change and I proceeded to approve.

The PI received the notification of an approved "admin" amendment, too.  She was advised why the IACUC office made a change to her protocol.   All very nicely documented.

Would it be handier to do this all within the amendment reason textbox, where the IACUC admin has a special button to approve?  Yup, and I'll put that into the product suggestion area.

It's good to share this fix.

Finally, to Cheryl about our weather in SoCal.  Already rather warm (reached the 90s yesterday).  Fire season has started and we are once again in drought times.

Bruce