PRISM FAQs

PSF, ACAR, FastTrack & Close-Out Forms

What is a Protocol Summary Form(PSF) in PRISM?

The Protocol Summary Form (PSF) is a form in PRISM that gets generated when you submit a new protocol or a 5 year continuation to the IRB

What is an Application for Continuing Review of Research(ACAR) in PRISM?
Federal regulations and OHRP guidance are quite clear about the requirements for continuing review: all studies need to be reviewed for approval at least annually. The Application for Continuing Review of Research (ACAR) is a form in PRISM that lets you submit your annual renewal online. 

NYSPI requires all studies to be reviewed as if new after five years. You do not have to submit an ACAR for a five-year renewal. When submitting a five-year renewal through PRISM, you will have to click on "Start a new draft protocol or 5 year continuation" after you log into PRISM and create a new draft protocol.

What is a Fast Track Form?
A Fast Track form can be filled out and submitted when the investigator needs to make revisions to material that does not require a change to the Protocol Summary Form (PSF). The IRB is currently accepting Fast Track forms only for recruitment material.

What is a Study Close-Out Form in PRISM?
A Study Close-Out form has to be filled out when the study has been completed. It has to be submitted when subjects have completed participation including all follow-up activities AND data analysis is complete.

How to Submit

How do I submit any form to the IRB?
Log into PRISM and click on the ‘My Studies’ tab. Search for the protocol by protocol name or IRB #. Click on the protocol to go to the protocol menu. Click ‘view related forms’ to view all forms that have been created for that protocol. Click the ‘Menu’ icon of the form that has to be submitted. Click ‘send form’ under the form menu and select the most appropriate option from the list of choices provided.

Alternately, while editing the form, a ‘send form’ button pops up on the page that will allow you to submit your form after the page is completed and saved.

How do I create and submit new protocols in PRISM?
After you log into PRISM, click ‘Start a draft protocol or 5 year continuation’ to create a new study. Fill out the information on that page and then click on ‘Open protocol’ to view the protocol summary form. Fill out all the sections in the form and hit the workflow options/send form button to submit it. Choose ‘Forward to Research Chief for initial approval (ALL NEW PROTOCOLS & 5 YEAR RENEWALS)’ to send it across for Research Chief Approval. The Research Chief will be notified of your submission by email and he/she will send your submission across to the IRB after approval.

***A 5 year continuation is treated as a new protocol in PRISM and will have to be submitted as a new protocol.It will be assigned a new IRB #. For more information on 5 year continuations, please click here.

How does the Research Chief approve and submit new protocols in PRISM?

The Research Chief will receive a notification by the PI via email when a new submission is sent for approval. After the Research Chief logs into PRISM, he/she will see a tab on the left hand side of the page that will say 'Research Chief'. On clicking it, he/she will be able to view Protocol Summary forms that require review. Click   to view the document as a PDF. Click  to approve and submit it to the IRB.

How do I submit an amendment through PRISM?
Log into PRISM and click on the ‘My Studies’ tab. Search for the protocol by protocol name or IRB #. Click the protocol title to go to the protocol menu. Click ‘start a new amendment only’ under the protocol menu. You will be directed to a page that will display all the PSFs that are there in the system for that protocol. Select one to make a copy, make revisions to this editable version and hit the 'send form' button to submit it. Choose ‘Submit directly to IRB’ to send it across to the IRB.

Note: If the system does not contain any PSFs for the specified protocol, you will be given the option to create a brand new PSF form from scratch. You also have the option to submit a hard copy.

How do I submit an annual renewal/continuation?
Log into PRISM and click on the ‘My Studies’ tab. Search for the protocol by protocol name or IRB #. Click the protocol title to go to the protocol menu. Click ‘start an annual continuation with or w/o an amendment’ under the protocol menu. You will be directed to a page that will display all the PSFs that are there in the system for that protocol. Select one to make a copy, make revisions to this editable version and hit the 'send form' button to submit it. Choose ‘Submit directly to IRB’ to send it across to the IRB..

Note: If the system does not contain any PSFs for the specified protocol, you will be given the option to create a brand new PSF form from scratch. You also have the option to create a new ACAR form from scratch and submit to the IRB.

Is the 5 year renewal submission process through PRISM different from an annual renewal?
Yes, the submission process is different for a 5 year renewal study. The IRB treats a 5 year renewal study as a new study and at 5 years, IRB protocols are assigned a new number with an “R” suffix. When submitting a five-year renewal through PRISM, you will have to click on "Start a new draft protocol or a 5 year renewal" after you log into PRISM and create a new draft protocol rather than creating a new PSF under your existing protocol number. 

An investigator may request a waiver of this 5 year review when the study is closed to new enrollment.

How do I submit a close-out memo?
Log into PRISM and click the ‘My Studies’ tab. Search for the protocol that you wish to terminate by protocol name or IRB #. Click the protocol title to go to the protocol menu. Click ‘Start a new IRB form’ to create a close-out memo (CloseOut).

How do I submit a Fast track Form?
Log into PRISM and click the ‘My Studies’ tab. Search for the protocol that you wish to create a FastTrack for by protocol name or IRB #. Click the protocol title to go to the protocol menu. Click ‘Start a new IRB form’ to create a Fast Track Form (FastTrack).

How do I submit the new Uploaded Protocol Summary Form?
In this section you have the option of uploading a portion of your Protocol Summary Form in PDF format.  This functionality will significantly reduce the amount of time required to enter the protocol information in the PRISM system.  If you choose to upload your Protocol Summary Form, you must use the word template found on the NYSPI Institutional Review Board website.  You are not required to use this option and may continue entering the required PRISM information to submit your protocol.  To use this option, select “Yes” for the first question and follow the directions below.

1.       Obtain the Protocol Summary Form Word template from the IRB website.  This template is found on the ‘Forms’ tab, under the PRISM section.  This template is protected and only the highlighted areas may be changed.

2.       Complete the protocol information on the template.  Depending on the type of protocol being submitted, not all of the sections within the template may be required.  Please be sure to verify which sections are required for your protocol.  Any sections not complete will result in your submission being returned to you. 

3.       When you are complete, save this document as a PDF.  Word allows the user to select options when choosing this format.  Be sure to select the option “Create Bookmarks Using.”  Then select “Headings” to create bookmarks in the saved PDF.   These bookmarks will be used in the final Unified PSF.

This PDF can be uploaded at this time.


How do I register to receive a login and gain access to PRISM?
Click on the REGISTER link on the top right of the NYSPI IRB website to request a login and access to the PRISM.

Re-Submit Forms to the IRB

How do I proceed after the IRB sends my form back for revisions?
You will receive an email from the IRB through PRISM that your form has been released for editing. You can view the IRB memo, edit and re-submit the form by following the links sent out in the email.

Alternately, under the form menu, click 'edit form' to make revisions to your form. Please indicate changes in bold, delete old attachments if not required from the 'Uploads' section of the form and re-upload revised bolded and unbolded copies for review and stamping. Do not delete forms that continue to be part of the protocol, just because those particular forms do not require revision.Click 'send form' from within the form or the 'send form' icon from the form menu to re-submit. You will be asked to complete a couple of steps during this process. The submission is completed when your form status changes to 'Submitted to IRB'.

Do consent forms, recruitment material, etc that have been uploaded to a form during initial submission need to be uploaded again while re-submitting for review/approval after revisions?
Any material requiring review has to be uploaded to the 'Uploads' section of the form. During every submission of your form to the IRB, the Uploads page should include all of the parts of the complete document as you intend for the IRB to review it. If documents have been revised, you will have to delete the old ones and re-upload bolded and unbolded copies of revised documents. Do not delete attachments or sections, previous to submission, unless you do not wish for them to be reviewed, approved and/or stamped. 
Everything that gets uploaded to the Uploads page of the form are final documents that will be considered for approval and will be stamped accordingly.

Form FAQs

How do I get to an existing form in PRISM?
Log into PRISM and click on the ‘My Studies’ tab. Search for the protocol by protocol name or IRB #. Click the protocol title to go to the protocol menu. Click ‘view related forms’ to view all forms that have been created for that protocol. Click the ‘Menu’ icon of the form whose menu you need to go to.

How do I edit an existing form in PRISM?
Log into PRISM and click on the ‘My Studies’ tab. Search for the protocol by protocol name or IRB #. Click the protocol title to go to the protocol menu. Click ‘view related forms’ to view all forms that have been created for that protocol. Click ‘Menu’ to go to the form menu. Click ‘’edit form’ to edit the form.

I have completed this page’ does not work for me. What do I do?
Please make sure that you have completed and filled out every question on that page. You will see a red asterisk besides questions that have not been completed.

Cutting and pasting from a word document into the text area provided messes up the formatting. How do I fix that?
The text area that you cut and paste into is an editor. You can use the following tools, ‘Paste as plain text’ or ‘Paste from Word’ from the editor toolbar to clean up the formatting.

Where do I upload materials that need to be reviewed and stamped?
Both forms, the PSF as well as the ACAR have an 'Uploads' section catered only for uploading attachments that need to be reviewed and stamped. This would include copies of consent forms bolded and unbolded, recruitment material, anything that needs to be reviewed. 

If your form is sent back by the IRB for revisions, please delete attachments that are not relevant under the 'Uploads' section, re-upload revised copies to the same section and re-submit.

 

***Please do not upload your memo in this section. You will be asked for the memo during the re-submission process.

 

I am unable to upload documents to the system. What do I do?
The PRISM system currently handles only PDF uploads. Please convert your document to a PDF before uploading it. You can use this free software to convert your files.

Where do I upload my memo?
A separate box will pop up prompting you to upload your memo during the submission process. Please do not upload your memo to the 'Uploads' page of the PSF and the ACAR.

Where do I view the PDF?
Log into PRISM and click on the ‘My Studies’ tab. Search for the protocol by protocol name or IRB #. Click the protocol title to go to the protocol menu. Click ‘view related forms’ to view all forms that have been created for that protocol. Click ‘Menu’ to go to the form menu. Click ‘view PDF of current version’ to view the PDF in it's current un-submitted form. Click 'View PDF of last submitted version' to view the PDF of a version that has been previously submitted to the IRB, if any.

Where do I find memos or other documents sent by the IRB?
Log into PRISM and click on the ‘My Studies’ tab. Search for the protocol by protocol name or IRB #. Click the protocol title to go to the protocol menu. Click ‘view related forms’ to view all forms that have been created for that protocol. Click ‘Menu’ to go to the form menu. Click ‘view form history’ to view all memos and additional files associated with the form.

Protocol FAQs

Where do I see all my studies?
You should be able to find all studies that you have access to, under the ‘My Studies’ tab.

Why can’t I see any studies after I log in?
You have to be added, given a role on any study that you need access to. This can be done by going to 'change personnel or modify title' under the protocol menu. The PI or anybody who is a part of the research team can add you.

Why can’t I find my name on the personnel drop down menu?
You should have had completed CITI training with NYSPI to find your name on the drop down list as it is filtered by investigator’s CITI credentials. Note, that CITI completed for NYSPI and Columbia differ and the IRB requires the investigator to complete CITI for NYSPI.

How do I add or change staff members on my protocol?
Log into PRISM and click on the ‘My Studies’ tab. Search for the protocol by protocol name or IRB #. Click on the protocol to go to the protocol menu. Click ‘change personnel or modify title’ to make changes to the research team. Select names from the dropdown list accordingly.

Note: Team members will not be able to add or remove anybody except research staff from the drop down menu after the protocol has been accepted by the IRB. Researchers will have to submit an amendment to the IRB to make that change.

How do I edit the title?
Log into PRISM and click on the ‘My Studies’ tab. Search for the protocol by protocol name or IRB #. Click on the protocol to go to the protocol menu. Click 'change personnel or modify title’. Scroll all the way till the end of the page to edit the title.

How do I see all my forms?
There is a 'Forms' tab that is visible on the Home Page after you log into PRISM. The 'Forms' tab displays all forms that you have access to. Clicking each individual form will take you to the form menu of the respective form.

Questions?

If you have any questions or comments, please email us at IRBMail .