Frequently Asked Questions
New CMS (Centers for Medicare and Medicaid Services) Billing Requirement: Modified Clinical Trial Policy Coverage Decision
For an IRB continuing review submission, do I need to resubmit documents that are already approved?
No, you will not need to resubmit already approved documents, unless you are making a modification at the same time and only includes documents related to the modification (i.e., revised protocol, revised consent forms, etc.). When submitting for an IRB continuation, you will need to upload updated Financial Disclosure documents.
I have one modification under review and now I need to submit another one.
Research Navigator and the IRB only allow one active submission at a time. This is to ensure that two modifications that may be mutually exclusive aren't handled by two separate IRB staff members and approved incorrectly.
If you absolutely need a more urgent modification to be submitted while one is currently under review, you can contact the IRB and have them 'release' your current modification submission. This will allow you to add your second modification and resubmit, and the IRB will review all material as one new modification.
Why do I need to work with the IRB on my first IRB modification or continuation?
Both the study team and the IRB Office have additional work to do to properly format and complete your Study records. Contact the IRB Office at 212.263.4110 before you begin your modification or continuation submission. Please allow about 1-2 days for these updates before you can submit for the continuing review or modification of your study.
Note: if you are starting a new study in Research Navigator, you do not need to contact the IRB.
Training and Support
How do I access the mandatory online training?
Step 1) Log on to the NYULMC network at http://atnyulmc.org.
Step 2) In “Applications” (right side) click “Administration.”
Step 3) Click “Human Resources & ODL.”
Step 4) Click iDevelop (note: if you select the star next to the application name, it will automatically appear in your favorites for applications so you don’t need to search next time you sign on).
Step 5) Once in iDevelop, click on “Course Catalog.”
Step 6) Type “Navigator” or “Research Education” into the search bar to find the online training.
Are there workshops that I can attend to ask questions about Research Navigator?
Yes. Research Navigator Workshops are provided for study staff who have taken all of the required iDevelop training modules and still have specific questions on how to manage their study. Staff from the OCT and IRB will be available to walk through your issues one-on one with you. Interested participant should sign up on the Office of Research Education (ORE) calendar.
I'm having problems with the Research Navigator system or one of its modules. How do I get support?
After you’ve taken all of the appropriate Research Navigator online training (see instructions above), your first point of contact is the Help Desk at 3-6868.
Studies: Active Prior to Research Navigator Launch
How do I access documents that were part of the Study Record in InfoEd-CTMS for active trials?
- In the ‘My Studies’ module, select the specific study of interest to open its Study Workspace.
- In the left hand margin of the Study Workspace, select the activity ‘View Legacy Documents’. You can link to any documents that were accessible in InfoEd-CTMS for that particular study.
- You then have the option to save these documents via ‘My Studies’ Uploads page or in the Documents tab of the CRMS module for future access.
Who do I call about problems accessing active trials that were accessible in InfoEd-CTMS?
If you experience problems accessing studies and you are the Study Personnel, please contact the Help Desk at 3-6868.
How do I submit a new study in the Research Navigator system?
After entering your Kerberos ID and password to log in to Research Navigator, you will be taken to a ‘landing page’ listing all the available administrative modules. Select the ‘Navigator Submissions’ tab to access the link to the My Studies and My Agreements modules.
Select the ‘Create New Study’ button on your home page. A new study submission SmartForm will display to begin your submission process. For more information about submitting a new study, go to the on-line modules entitled, “Submitting a Study”:
- Login to NYUOnsiteHealth.
- Click the ‘iDevelop LMS’ link under the ‘Quick Links’ section.
- Once in iDevelop, click on ‘Course Catalog.’
- Type ‘Navigator’ or ‘Research Education’ into the search bar to find the training modules.
A co-worker created a duplicate study in My Studies. Can one of the study records be deleted?
Yes. To delete a duplicate study submission that is still in ‘Draft’ status, use the ‘Discard’ activity on the left hand margin of the Study Workspace to delete the duplicate study. If both studies were already submitted, use the ‘Withdraw’ activity instead (also located in the left hand margin of the Study Workspace).
How do I submit a sub-study in the Research Navigator System?
A sub-study, also called an ancillary study, is a study that is related and dependent upon a parent study. The most straightforward way of submitting a sub-study is:
- Navigate to the ‘My Studies’ module.
- Click on the parent study of interest to open it to the Study Workspace.
- Choose the ‘Create Sub-study’ activity on the left hand margin of the study workspace. This will launch a new study submission SmartForm that will be linked to the parent study.
To generate a study number, which fields do I have to complete in the My Studies Initial Study Information Form?
You will generate a study number by saving the initial SmartForm page, with or without entering data in the ‘My Studies’ module. However, you should at least enter the name of the Principal Investigator and the Brief Study Title when saving the first page to generate a study number. Otherwise, you may not be able to distinguish which study and/or investigator is associated with the study number when reviewing your list of studies in ‘My Studies’.
What is the purpose of the 'Create CRMS Submission' button in the Study Workspace? Isn't a CRMS record created automatically when I submit the study?
The purpose of this button is to allow the user to create a CRMS record and begin working in that module before they are ready to submit the study through ‘My Studies’ to the IRB and other required review offices. For this action to be processed, you must have at least completed the mandatory fields in ‘My Studies’ submission SmartForms. Upon completion of this action, you will receive the following message:
You have chosen to create a CRMS record for this study before the study has been officially ‘Submitted’ in ‘My Studies’. Please note that any changes made at the ‘My Studies’ level after the CRMS record is created will not be reflected in the CRMS system, and therefore must be updated in both places.
This message serves to notify you that once the CRMS record has been created, and future edits made within the ‘My Studies’ module will not be reflected in CRMS record of that study.
I forgot to include a document in a study already submitted through 'My Studies'. How can I edit my submission?
If you have formally submitted a study through the 'My Studies' module, but realized after that you need to include another document or make changes to a SmartForm entry, please contact the IRB: 212-263-4110.
How can I re-open a study in 'My Studies' that I previously closed through the IRB? Do I need to let the IRB or OCT know?
To re-open a study that has been formally closed, please contact the IRB: 212-263-4110.
How can I partially complete the 'My Studies' SmartForms (when I click 'Continue' at the bottom of the form, it won't let me proceed if I leave any required fields blank)?
Once you have saved the first ‘My Studies’ SmartForm page for the study, a new ‘Jump to’ menu will appear at the top of the page. Selecting that menu item will display a drop-down list of all the ‘My Studies’ SmartForm pages associated with this study. Select any page on the drop down list. You will be able jump to any pages you wish and avoid the error message that displays when you click the ‘Continue’ button before completing all the required fields.
Note: if someone on your study team hits the ‘submit’ button on a study that still has incomplete required information, an error message will display, reminding the submitter that there is missing information. Navigating through each page by hitting ‘Continue’ will highlight the incomplete mandatory fields.
BRANY (Biomedical Research Alliance of New York) IRB Studies
My study is being managed by BRANY. Do I still need to submit the study through Research Navigator?
Yes. All submissions need to be processed through Research Navigator. Selecting BRANY as the IRB of record on the ‘My Studies’ SmartForm registers your study with NYULMC and triggers a slightly different workflow for interacting with BRANY. The OCT will still need to review such submissions, as is standard for all clinical research studies at NYU, regardless of the designated regulatory authority. The status of your BRANY IRB review will be reflected in the Study Workspace for that study.
Ancillary Review Committees (e.g., ESCRO, Radiation Safety, IBC, etc.)
Do I still need to submit a separate application to ESCRO, Radiation Safety, IBC, or other ancillary review offices?
No. Research Navigator is an integrated system. Based on the information you enter into the ‘My Studies’ SmartForm application, the system will display the list of required ancillary committee reviews and submit your study to all applicable committees/offices. You may be contacted outside of the system by these ancillary review offices if further information is needed.
The status of any applicable ancillary review committee will be displayed in the My Studies Workspace for each study, and the system will automatically notify the PI and study team once an ancillary review body has made any changes to the review status of a submitted study.
Why is the Conflict of Interest (COI) review required for my study? We do not have a potential conflict.
COI review is mandated for all projects submitted to the IRB. For more information, visit the COI Management Unit website and select ‘Contact Us.’
CRMS – General Topics
How do I know whether my study needs a billing grid?
Any study that can or will generate a bill or is using Hospital services (Tisch, HJD, Bellevue, VA) requires a billing grid.
I received a sponsor budget template. How should I handle this in the CRMS?
The sponsor budget template can be uploaded in Research Navigator using the 'Manage Document' activity button.
Can I use the sponsor budget as a template to create my billing grid?
Yes, you can modify the sponsor budget to create a billing grid. This involves a few key modifications:
- inserting a column in the template to capture CPT codes (if applicable)
- inserting a column in the template to capture service providers/locations of the procedure
- highlighting the clinical services/procedures that are considered routine care (sometimes called standard of care ‘SOC’). There are a number of ways to highlight services/procedures that are routine care—see the OCT budget grid templates or contact the OCT: 212.263.4210 or firstname.lastname@example.org
How do I upload my study billing grid to the CRMS system?
Study documents can be uploaded in the CRMS system using the ‘Manage Documents’ activity in the CRMS Workspace for a given study.
- Once logged into the Research Navigator CRMS application, select the specific study of interest from the list of studies displayed on your CRMS homepage, and the study’s CMRS Workspace will display.
- From the study’s CRMS Workspace, note the ‘Activities’ section of the left margin of the screen, and select the ‘Manage documents’ activity.
- A pop-up window will appear allowing you to name and upload documents and also provide any comments with the upload.
Subject Registration and Visit Tracking
What is the difference between an 'enrolled' subject and an 'accrued' subject?
A subject is considered enrolled once a consent form is assigned.
A subject is considered accrued when he/she passes all required screening tests in the screening phase of the study and is deemed eligible for the active phase of the study. If there is no screening phase of the study, the subject is accrued once the consent is signed.
How will I know the type of subject registration my study will require?
There are 3 types of Subject Registration:
- standard – 5 questions (for studies involving billable items and/or is industry supported)
- minimum – 3 questions (for studies not involving billable items, but collecting PHI)
- enrollment tally – only an overall enrollment number is entered (studies not collecting PHI).
The type of registration required will be assigned for you in CRMS based on various characteristics of the study.
Using either standard or minimum registration
In the CRMS module, from the list of studies, select the study for which you would like to register the subject. The CMRS Study Workspace will display.
- Select the ‘New Subject’ button located on the left hand side of the Study Workspace. A ‘Registration’ SmartForm will display.
- Complete the questions on the initial SmartForm and select ‘Continue’
- Complete all subject registration SmartForms, then select ‘Finish’
Using 'enrollment tally'
In the CRMS module, from the list of studies, select the study for which you would like to register the subject. The CMRS Study Workspace will display.
- Select ‘Update Enrollment Numbers’ under the activities section of the left hand side of the workspace. A pop-up window for enrollment data entry displays.
- Update the enrollment information in the pop-up window, and then select ‘OK.’
Can I assign my own Subject ID number?
Yes, you can. However, if you do not assign a unique subject ID, the system will auto generate a number for you. This will appear on the Registration Screen AFTER you save the information by selecting 'Save' or 'Continue'.
What do I do if I don't know the Medical Record Number (MRN) for the subject that I am registering?
Select ‘MRN Not Available’ on the subject registration SmartForm, and the system will allow you to continue without entering the MRN. By selecting ‘MRN Not Available,’ the auto-population feature of the system is disabled, and you will need to manually enter the subject information. If you know the NYULMC MRN and enter it, the subject’s information will auto-populate the SmartForm.
NOTE: The Research Navigator CRMS module is not able to auto-populate subject information for Bellevue or VA medical record numbers.
Can I accrue a subject into the study if they do not meet the eligibility criteria?
Yes, the system allows you to enter a subject into a study that doesn't meet the eligibility criteria. The system also provides a means of documenting the reason for such exceptions to study accrual.
Will I be able to schedule study visits in advance?
Yes, the system allows you to schedule study visits in advance. In the CRMS Study Workspace, select the ‘Log or Schedule Visit’ button, on the left hand side of the workspace. Only the ‘Schedule Protocol Visit’ form needs to be completed. Once the information has been entered, select ‘Save’ then ‘Exit’ to schedule the visit.
Does Research Navigator interface with the Epic Medical Record System?
Currently, there is no direct interface to Epic. This is being planned for a later system update.
Will the subjects that I registered in InfoEd CTMS be carried over into Research Navigator CRMS?
Yes, subjects and their visits from ‘legacy studies’ will be transferred into CRMS.
How will invoicing occur for my study?
The process for study invoicing will not change. The Office of Clinical Trials (OCT) will continue to facilitate the information exchange from the CRMS system to the PeopleSoft financial system to support study invoicing.
Clinical Research Billing
What effect will Research Navigator have on the clinical research billing process?
For Phase 1 release, you will continue to follow the same processes that have been in place prior to the launch of Research Navigator. This includes developing a billing grid for each study and submitting it to the Office of Clinical Trials (OCT) and continuing to use your research labels and orders when scheduling clinical tests/procedures associated with research visits.
The only change will be that the Research Navigator CRMS system will be used instead of the InfoEd CTMS system to register and track research subjects.
Who should complete the 'My Agreements' SmartForm?
The ‘My Agreements’ SmartForm can be completed by a responsible faculty member (PI) or any other staff who will be acting on behalf of the faculty member to submit the agreement. If a delegated staff member will be completing the SmartForm, it is important they understand key information about the agreement being submitted, for example, the counterparty of the agreement (the other participant to the agreement), the purpose of the agreement, (e.g. confidentiality disclosure, funding, data sharing, etc.), and whether the agreement is associated with a study.
How will I know which office is reviewing the agreement I have submitted?
The ‘My Agreements’ module uses SmartForm information, such as the type of counterparty (the other participant to the agreement) and the category of agreement, to automatically route the agreement submission to the appropriate OSR contract unit. The unit responsible for negotiating the agreement, also known as the ‘Lead Contract Unit’ can be viewed in the main information area of Agreement Workspace. Look for the label: ‘Lead CU’ (Lead Contracting Unit). Once the agreement has been assigned to a specific OSR reviewer, the name of the reviewer will display just above the ‘Lead CU’.
How can I check the status of my agreement?
Once logged in the Navigator Submissions module, select the ‘My Agreements’ tab, and a list of all agreements with which you are associated will display. Look for the column entitled ‘Status’ to see the current status of each agreement listed.
Another way to view the status is to select a specific agreement from the list. This will open the Agreements Workspace, where the status of the agreement will display in amber color in the upper left hand side.
Can I make changes to my agreement submission?
Changes can be made to an agreement submission as long it is still in a ‘Prepare submission’ status.
- To edit a submission SmartForm, select the ‘My Agreements’ tab, then select the specific agreement you wish to edit.
- Select that agreement and the agreement’s Workspace will display. Select the ‘Edit’ button located in the top left hand side of the Workspace – the agreement’s SmartForm will display for editing.
- When finished editing, select the ‘Finish’ button located on the far right of the SmartForm page – this will return you to the My Agreements Workspace where you can then select ‘Submit to OSR Office’ on the left hand side of the workspace when you are ready to submit.
- Once you select ‘Submit to OSR Office’ activity, the agreement will be formally submitted, and its status will change to ‘Submitted.’
NOTE: Once in the submitted state, you can no longer make changes to the SmartForm. A member of the lead contract unit to which the agreement has been assigned will be in touch to follow-up on the negotiation of the agreement.
Can I withdraw my agreement submission once the submission is made?
To withdraw a submitted agreement, use one of the following approaches:
- From the My Agreements Workspace for the specific agreement, select ‘Log correspondence’ from the ‘My Current Actions’ in the left hand margin of the Workspace. A pop-up window will appear to log a correspondence. Type your request to withdraw the submission, and then select ‘OK’.
- Contact the OSR reviewer listed for the agreement by phone or email to request a withdrawal of the submission.
How do I link a study with an agreement record?
There are three ways to link an agreement with a study based on 3 scenarios:
- Link a new agreement to an existing study in the ‘My Studies’ module: This involves submitting a new agreement from within the study’s Workspace in the ‘My Studies’ module. Once logged into to the ‘My Studies’ module, select the study to display its Workspace. In the left hand margin of the Workspace, select the ‘Create’ button under the label ‘Create Agreement.’ The Agreement SmartForm will appear for completion and will be automatically linked to the study.
- Link a new study to an existing agreement in the My Agreements module: This involves creating a new study in the ‘My Studies’ module and linking it to an existing agreement in the My Agreements module. As you complete the SmartForms for submission of the new study, in the ‘Uploads’ section of the SmartForm, select ‘Add’ for item 7.0: ‘Associated Agreements.’ A pop-up window will appear displaying all the agreements to which you have access. Select the appropriate agreement, then select ‘OK’
- Link an existing study to an existing agreement: This approach allows you to directly link studies and agreements that both already exist in the ‘My Studies’ and ‘My Agreements’ modules. Start with the ‘My Studies’ module, and select the study of interest to open its workspace. Once in the study’s workspace in the ‘My Activities’ section of the left hand margin, select ‘Manage Agreements.’ A pop-up window will appear displaying all the agreements to which you have access. Select the appropriate agreement, then select ‘OK.’
How do I view studies that are linked to an agreement?
Go to the MyAgreements Workspace and scroll down to the bottom. Linked studies will display under the ‘Studies’ tab. Selecting the study number will link you directly to that study in the ‘My Studies’ module.
How do I view agreements that are linked to a study?
Go the MyStudies Workspace toward the bottom of the page and select the tab labeled ‘Related Agreements.’ Linked agreements will display under the ‘Related Agreements’ tab. Selecting the agreement title will link you directly to that agreement submission in the ‘My Agreements’ module.
How do I link a grant with an agreement in Research Navigator?
For the phase 1 release of Research Navigator, grants are not electronically linked to agreements in the system in the way that studies and agreements can be linked. Rather, the grant number can be associated with an agreement as reference information. When completing the My Agreements SmartForm, in ‘Section 5.0: Agreement Association’, insert the Grant number (assigned by the Research Navigator Grants module) into the Grant textbox. Once you complete and save the SmartForm, the grant number will appear on your agreement workspace in the top left corner.
NOTE: since this is not an electronic link, you won’t be able to click on the grant number to navigate between the My Agreements module and the Grants module. Such an electronic link is planned for a future system enhancement.
I have a Confidentiality Agreement to submit that is related to a potential clinical study. What do I do?
- Start by creating a new study record in the Research Navigator’s ‘My Studies’ application:
- Logon into the Research Navigator system, select ‘Navigator Submissions’ and from your homepage, select the option to create a new study. A study SmartForm will display.
- At a minimum, enter the Principal Investigator and a short title for the study.
- Select ‘Save’ from the menu at the top of the page.
- Select ‘Exit’ which will return you to the Workspace for that study which displays general information about the newly created study and provides you with certain actions or activities you can apply to this study. NOTE: An automatically assigned study number and the short study title will appear at the top of the Workspace screen.
- In the left hand margin of the Study Workspace toward the bottom, you will see a button to ‘Create Agreement.’ When you select the ‘Create Agreement’ button, Research Navigator will launch an agreement submission form that is automatically linked to the study.
- Complete the SmartForm (in this scenario it will be to submit the confidentiality disclosure agreement for this study) and then select ‘OK.’
- You will be taken to the Workspace for that agreement submission. In this agreement Workspace you will see the agreement name and number at the top of the page, followed by some information about the agreement – toward the bottom of that information is a label ‘Study#s’ which displays the linked study. This study number is also a link to the study in the ‘My Studies’ module should you wish to navigate from the agreement to the study.
How do I submit amendments to agreements?
To submit an amendment to an existing agreement, start by creating a new agreement in the ‘My Agreements’ module. When completing the submission SmartForm, select ‘Yes’ to question 4 of the ‘My Agreements’ SmartForm: ‘This is an amendment to and existing agreement.’ A new option displays asking you to select the existing agreement. By choosing the ‘Select’ button, a pop-up window will appear which displays a list of existing agreements with which you are associated. If you are unable to find the agreement you are looking for, select ‘Cancel’ for the pop-up window and describe the agreement you are looking for in the text box labeled: ‘Please enter a short description of the agreement if not found in the list above.’ Once the form is submitted to the OSR contract office, a contract reviewer will follow up with you to assist in identifying the original agreement that is to be amended.
What agreement related documents should I upload in question 14 of the 'My Agreements' SmartForm?
The type of agreement-associated documents you upload will depend on the type of agreement you are submitting. Examples of important documents that can be associated with an agreement include: a template budget and payment terms provided by the counterparty/sponsor, an indemnification letter, a project description, financial forms such as a payee information form or W9 form requested by the counterparty/sponsor, and various OSR's specific forms such as a Material Registration Document (MRD).
Will I receive e-mail notifications about my agreement submission?
Yes. The Research Navigator ‘My Agreements’ module sends email notifications for the scenarios noted below to the author of the submission, the responsible faculty member (PI), and the primary contact listed on the agreement SmartForm:
- Submission of an agreement
- A specific contract reviewer has been assigned
- The agreement has been fully executed
Who has view access to my agreement submission?
Those able to view the agreement submission and any executed agreement include:
- the author of the submission
- the responsible faculty member (PI)
- the primary contact listed on the agreement SmartForm
- OSR contract reviewers
- if the agreement is linked to a study, anyone named as study personnel
IMPORTANT NOTE: Only the author of the submission, the responsible faculty member (PI) for the agreement, and the primary contact listed on the agreement SmartForm will receive system notifications from the ‘My Agreements module.’ In other words, study personnel will not receive any system notifications from the ‘My Agreements’ module unless they are the author of the submission, the responsible faculty member (PI) for the agreement, or the primary contact listed on the agreement SmartForm.