Clinical Research FAQ

MyResearchPath  is the definitive source of knowledge about research at Duke. This is a curated FAQ tailored to the questions and answers commonly applicable to Ortho clinical research. Your question not answered here or you just don't know where to start? Email us: orthoresearch_help@duke.edu

Hint: If it appears the link to a document in Box is broken, try logging in....

Need to know what those letters mean? The Duke wiki has a list! Look here

Do you need an agreement? Do you need to know if you can sign an agreement?

The easiest answer is that if it was sent to you from outside Duke, no. Instead, you should send the agreement to the team indicated by the tool in MyResearchPath.

If it was sent to you by a member of the Office of Research Contracts, or the Office of Research Agreements, and they asked you to sign it, then yes, please sign it.

MyResearchPath has a tool where you select the conditions that apply to your situation, and it will provide the team or teams to contact.

If you want to obtain a DTA, we recommend

  • Your IRB is specific about what information is going to/from Duke
  • Your IRB is approved

You can get to the submission form here.

Once you have completed it, you will need to email a copy of the completed form to the Office of Research Contracts group indicated by the MyResearchPath tool.

It will NOT automatically be sent.

Important notes

  • Duke data cannot leave Duke without an agreement. This also means that personnel leaving Duke must have an agreement to take any data with them.

  • Duke research data must be accessible to Duke even after the paper has been published, usually for at least six years, but sometimes longer.

Within the Duke Library is the Center for Data and Visualization Sciences and they have wonderful resources for helping with all things related to data management.

If your question is just, 'can I put this data there,' you may find the SecureIT tool to can provide you the information you need.

If you are doing CLINICAL research, please be sure that whatever you do is reflected in your DRDL. If you aren't sure, please reach out to orthoresearch_help@duke.edu to verify.

If you're just overwhelmed, you can also request assistance here

 

Request that here

We have a tip sheet for how to do that in PACE.

If this doesn't work for your needs, please contact the biostatisticians for support.

Please contact orthoresearch_help@duke.edu to get a BOX folder created for your research study.

Please take BOX training.

If you want de-identified data access only, you can access DEDUCE outside of PACE

Otherwise, you must access DEDUCE from within PACE

First, you must request a DEDUCE account through Service Now. Directions are here.

Then, you must complete this LMS; ACE-D110 Getting Started with DEDUCE (online) (Unfortunately, this isn't a direct link and you'll need to search for this course in the catalog.)

Follow the directions on this tip sheet for how to submit a Service Now ticket to get your access reinstated.

If you wish to look at non-de-identified data prior to obtaining IRB approval for a study, you MUST obtain permission via a Review Preparatory to Research form.

Please note, as described in the form, there are very specific regulations associated with this activity to limit use.

 

You can search through the variables in DEDUCE here

In addition to the DEDUCE LMS training, DEDUCE has tutorials you might find useful.

You can also request one-on-one DEDUCE assistance.

DEDUCE can do 2 things that SlicerDicer can't.

  1. If you have a list of people, you can upload that into DEDUCE and search only on those individuals.

  2. It can do text searching of notes.
    This is not something to undertake cavalierly, as it is particularly possible to make data extraction errors via this method.

Horvath MM, Rusincovitch SA, Brinson S, Shang HC, Evans S, Ferranti JM. Modular design, application architecture, and usage of a self-service model for enterprise data delivery: the Duke Enterprise Data Unified Content Explorer (DEDUCE). J Biomed Inform. 2014 Dec;52:231-42. doi: 10.1016/j.jbi.2014.07.006. Epub 2014 Jul 19. PMID: 25051403; PMCID: PMC4335712.

You reference DEDUCE for the same reason you reference the computer programs you use. In order for your audience to understand your methodology, you need to provide an adequate description of the tools you used.

Duke Ortho has a Grant Submission Guide. These are a few common questions.

The form you need to submit is here

Please note, there are TWO forms.

  • The Intent to Submit.
  • The Proposal Intake form.

Continue the process and complete the Proposal Intake form right after the Intent to Submit.

While you can stop after the first form, the grants folks can't do much for you without the information from the second form.

If you need more assistance, you can request it here

The grant submission timelines are here.

You should note that these deadlines are based on BUSINESS days.

So, depending on how far you're going back, you may need to add 2-6 days to get CALENDAR days. Please also remember to factor in holidays.

Here's a list of common errors and how to avoid them.

Contact orthoresearch_help@duke.edu.

We would love to help you figure that out. In addition to the draft grant submission, please send us whatever you have in terms of a draft protocol. That will help.

Contact orthoresearch_help@duke.edu.

We are mostly likely to be able to assist with facilities and human subjects sections.

Request that here

Almost certainly.

It's the same concept as not personally signing an agreement. Even though it seems like a 'you' thing, in actuality, it's a 'Duke' thing.

 

Only if you want to accept the money should it be awarded.

 

It is true, though, that some small travel grants are treated differently than standard grants. Look here for guidance to see if your grant is one of these.

 

No. Reach out to orthoresearch_help@duke.edu for next steps.

You need

  • Final protocol
  • Draft budget
  • Draft contract

And then you should complete the Ortho New Study Intake Form

The time varies. Please contact orthoresearch_help@duke.edu for more information

Yes.

The IRB application should reflect the receiver as outside key study personnel.

You should complete the DUA/DTA form and there should be a data use agreement in place.

The DRDL should accurately reflect the plan for data de-identification and data transfer.

No. But you must obtain permission via a Review Preparatory to Research form.

Please note, as described in the form, there are very specific regulations associated with this activity to limit use.

Yes.

That's a bit complicated. Here's a flow chart to help guide you.

Commonly,

  • Retrospective studies can.
  • FDA related studies can't.
  • Studies that are both retrospective and prospective in design are usually not exempt.

Reach out to orthoresearch_help@duke.edu for more information about a specific situation.

Standard, clinical care is not research.

However, the lines are sometimes confusing. Contact orthoresearch_help@duke.edu if there is any uncertainty.

No.

If you are doing a PROSPECTIVE study, you need to go through the Ortho CRU feasibility process before submission. Submit this Ortho New Research form to start.

If you are doing a RETROSPECTIVE study, you need to go through the approval process for your division. Check with the division chair. You may alternatively submit the Ortho New Research form for additional support.

If you have any questions, please contact us, orthoresearch_help@duke.edu

Technically, no.

HOWEVER, we have found that very rarely do proposed projects actually meet the QI definition, and IRB review is the only way for a study to be definitely determined to be QI.

So, we strongly recommend an IRB submission.

 

From the standpoint of the IRB, if you are collecting any new information from a subject, this constitutes prospective research.

However, yes, it is still a retrospective study design.

No. Patient care does not fall under IRB regulations.

However, if you transition from patient care to research, you do need to obtain IRB approval.

Reach out to orthoresearch_help@duke.edu if there is any uncertainty.

General submission tip sheet

Adding a funding source/sponsor tip sheet

Retrospective chart review draft IRB maker

Key notes:

You MUST have a primary regulatory coordinator. This person will be asked to complete the DRDL.

As part of your key study personnel, have an ortho CRC as a contact and study coordinator on the study, even if they will not be involved. This will allow that person to assist if there are problems. If you aren't sure who to include, reach out to orthoresearch_help@duke.edu

Viewing and printing KSP tip sheet

Removing someone from KSP tip sheet

Adding someone to KSP tip sheet

If you're working with a statistician(s), don't forget to add them to the IRB!

If you're adding someone who is:

  • Not a Duke employee
  • An adjunct or affiliated Duke person
  • An undergraduate student or volunteer

You will need to add them as EXTERNAL key study personnel

When adding an outside Key Person to your IRB, follow this process.

The PACE website is here and is the definitive source of PACE info.

To use PACE or a PACE REDCap project, please complete this LMS training

 

Need more help?

PACE cost estimates can be found here towards the bottom of the page

Use of PACE is governed by Duke policy and DOCR policy

If you are uncertain if you need to use PACE, please contact orthoresearch_help@duke.edu for more information.

Go here and choose "DESKTOPS"

There is also a video tutorial and a tip sheet

PACE is at heart just a virtual desktop and should behave more or less like a PC or PIN station.

If a visual would help, check this out.

Need more help?

Complete this form and wait for an Ortho admin to email you a CoreResearch@Duke Service Request ID

Then, submit a ServiceNow ticket here following these instructions

Complete this form and wait for an Ortho admin to email you a CoreResearch@Duke Service Request ID

Submit a ServiceNow ticket here using these instructions

Once you get a folder, you will probably need to restart your PACE virtual machine in order to see it.

(Periodically, the PACE virtual machine restarts automatically in between times the user accesses PACE. When this happens, the user doesn't always notice that a restart has happened. Thus, it may give the confusing appearance that sometimes a PACE restart is required and sometimes it isn't.)

Here is the link to the group management site

There is a tip sheet for managing shared folders.

Once added to a PACE folder, each person will probably need to restart their virtual PACE machine before they can actually see and access the folder.

(Periodically, the PACE virtual machine restarts automatically in between times the user accesses PACE. When this happens, the user doesn't always notice that a restart has happened. Thus, it may give the confusing appearance that sometimes a PACE restart is required and sometimes it isn't.)

Yes.

Every project needs to have data that is accessible by Ortho research for the purpose of auditing. Thus every project needs its own folder.

To export anything from PACE it must be de-identified and matching the IRB application and go through the Honest Brokers.

The process for getting data out of PACE is described here in the 'Requesting Honest Broker Services' tab and in this tip sheet and in this tip sheet

Complete this form and wait for an Ortho admin to email you a CoreResearch@Duke Service Request ID

Complete a Service Now Ticket

Here is a video tutorial for importing and exporting data from PACE.

 

The process for getting data out of PACE is described here in the 'PACE Honest Broker Exports & REDCap' tab.

You will need to complete a Service Now ticket

Here is a video tutorial for importing and exporting data from PACE.

Start by going to https://medschool.duke.edu/pace

Then go to the 'PACE Links' tab and click the 'PACE Data' button

Log in- twice. This is the transfer portal. It will allow you to put data on to your PACE Home (U) drive. So click on that folder to open it. Using the buttons at the bottom of the screen, add your file, and then upload it. (Note, those are 2 steps).

Once you've done that, go into PACE directly and move for file from your U drive into the project folder.

Here is a video tutorial for importing and exporting data from PACE. There is also a tip sheet

A list of the currently available software is available. You have to look at the top menu bar under the image of the building to find the 'software' tab.

WITHIN PACE, please use Windows File Explorer to navigate to  S:\Open Source\Windows followed by the application name to find and open the program installer.

If you need software that's not on their list, request it here.

PACE is a little different. You do need to indicate in your methods section that you used the Duke Protected Analytics Computing Environment.

 

Then, in your acknowledgments, add this:

  • The Duke Protected Analytics Computing Environment is funded through Grant Award Number UL1TR002553 from the National Center for Advancing Translational Sciences (NCATS), a component of the National Institutes of Health (NIH) and Duke University. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.

 

Important Note
You will have to submit the paper to PubmedCentral. Be sure to save all of your submission materials and contact nihpublicaccesscompliance@dm.duke.edu for assistance.

Having a well-defined question is the first step to a well-designed study.

Here is a worksheet that uses the PICOTTT (population, intervention, comparison, outcome, time, type of question, type of study design) system.

After you know what you want to ask, you need to develop your study design.

For example,

  • Evaluate the worthiness of the question.
  • Identify any co-variables.
  • Determine inclusion/exclusion criteria

Here is a worksheet to help you.

 

You can also request assistance here

If you are doing a PROSPECTIVE study, you need to go through the Ortho CRU feasibility process before submission. Submit this Ortho New Research form to start.

If you are doing a RETROSPECTIVE study, you need to go through the approval process for your division. Check with the division chair. You may alternatively submit the Ortho New Research form for additional support.

If you have any questions, please contact us, orthoresearch_help@duke.edu

Having a great study is great only if you can carry it out.

  • If you are doing a prospective REGULAR study
  • If you are doing a prospective EXEMPT study

If you're having trouble, please contact orthoresearch_help@duke.edu for more information.

 

This REDCap survey will help make sure you have adequately designed your retrospective study and will create a draft IRB application and protocol for you.

After you have the study designed, you need to go through the approval process for your division. Check with the division chair. You may alternatively submit the Ortho New Research form for additional support.

Our Library has amazing resources for anyone wanting to do a systematic review at Duke.

To request biostatistics assistance from the Biostats core, complete this form

If you are a trainee, you may also have your PI reach out to Dr. Cook for biostatistics support.

You can also submit a request for help here

Templates-

Please note, this area in particular is a work in progress.

 

Important information from the IRB here.

You can also work with the Duke Recruitment Innovation Center.

Request assistance here

Request that here

Request that here

Templates for presenting Duke Ortho work via powerpoint are here

The Duke medical library has great resources for folks making posters. Look to the right hand side for the templates.

Request that here.

Request that here

The Duke medical library has lots of resources when you're ready to publish.

You should also review the appropriate checklist to make sure you have reported everything you need to in your manuscript. (For example, STROBE, CONSORT). If you aren't sure which you need or can't find the right checklist, go to the EQUATOR network tool. (All the checklists came from EQUATOR).

One thing to consider early would be publication fees. Be sure you know how much it will cost at the journal where you wish to submit and that you have a funding source.

 

Contact radiology-deid@notes.duke.edu for more information about services by our MultiD Lab.

For large numbers of images, try this PACE option instead.

Please fill out this form if you will need to collect research information from clinical radiology.

Here is everything you could want to know about CAMRD, the Center for Advanced Magnetic Resonance (MR) Development, where we do research MR imaging.

Log in to https://redcap.duke.edu using your Duke credentials.

 

If this is your first time, read and respond to the email you receive.

 

You cannot add yourself to a project. Someone already on the project must add you. If the project is part of a research study, you will probably also need to be KSP prior to being added to the study.

 

If you are adding someone to a study.

  • Verify the person is KSP
  • Get the person's Duke user id
  • Find out what the person will be doing with the REDCap project.

Then, fill out a REDCap support request form.Choose "User Rights/Roles Request"

You will eventually be asked what role to give the person. Here's a quick suggestion if you have no idea.

  • If they will only be doing data entry, "Data Entry"
  • If they will be modifying the REDCap project itself, "Project Builder"
  • If they will be interacting with the data, but not modifying the project, "Coordinator"

You reference REDCap for the same reason you reference the computer programs you use. In order for your audience to understand your methodology, you need to provide an adequate description of the tools you used.

This is the reference information per REDCap.

Please cite the publications below in study manuscripts using REDCap for data collection and management. We recommend the following boilerplate language:

Study data were collected and managed using REDCap electronic data capture tools hosted at [YOUR INSTITUTION].1,2 REDCap (Research Electronic Data Capture) is a secure, web-based software platform designed to support data capture for research studies, providing 1) an intuitive interface for validated data capture; 2) audit trails for tracking data manipulation and export procedures; 3) automated export procedures for seamless data downloads to common statistical packages; and 4) procedures for data integration and interoperability with external sources.

1PA Harris, R Taylor, R Thielke, J Payne, N Gonzalez, JG. Conde, Research electronic data capture (REDCap) – A metadata-driven methodology and workflow process for providing translational research informatics support, J Biomed Inform. 2009 Apr;42(2):377-81.

2PA Harris, R Taylor, BL Minor, V Elliott, M Fernandez, L O’Neal, L McLeod, G Delacqua, F Delacqua, J Kirby, SN Duda, REDCap Consortium, The REDCap consortium: Building an international community of software partners, J Biomed Inform. 2019 May 9 [doi: 10.1016/j.jbi.2019.103208]

Link to articles: 

Fill out this form to schedule time to meet with REDCap staff.

REDCap has office hours four days a week.

There are trainings on REDCap or on LMS (search REDCap)

 

Yes. But it isn't free. Email redcap-docr@duke.edu for more information and to get a quote.

Answer here is a conditional yes.

In the 'Other Functionality' in the main project Home and Design, you can make an XML copy of a project. Copy without the data. Then in the new project request, provide the XML file. You will end up with a duplicate of the first.

However, much of the time, you don't want to copy a WHOLE project, you just want sections. To do this, you can download the data dictionary of the project you want to copy, copy the rows you want, and then paste them in the data dictionary of your new project. Before doing this, please watch the training video and download the demo dictionary. Here is a starter ortho data dictionary

Add the PI and the RPM to the project if they aren't there already.

If you are finished collecting, but not analyzing data, in the 'Other Functionality' tab, you can change the status to 'Move to Analysis/Cleanup Status'.

If you are closing the IRB, you can close the project. In the 'Other Functionality' tab, change the status to 'Mark Project as Completed'

Yes, to both. They are set up using either the 'Alerts & Notifications' function or via the 'Automated Surveys'

Using REDCap to set up automatic emails is free.

Using REDCap to set up automatic text messages is not free. To see a demo, click here

 

 

No. It can work for most kinds of data you need to manage. Per REDCap's front page,

"REDCap is a secure web platform for building and managing online databases and surveys. REDCap's streamlined process for rapidly creating and designing projects offers a vast array of tools that can be tailored to virtually any data collection strategy."

Development is for building and testing your project. Enter in lots of dummy data. Practice data entry, automated messages, and branching logic.

Once you are sure you have it, look to the bottom of the 'Project Setup' tab for the project and choose 'Move Project Into Production'.

It will ask if you want to save the data. It's all practice data, so no.

 

Well, that depends. If your project does not not say at the top "This is a PACE Project", then you don't have the right permissions. Ask the person in charge of the project to change your access.

If it DOES say "This is a PACE Project" at the top, then you can't export- even from within PACE to PACE. Prepare the data you want to export and then request an honest broker transfer the data for you.

Be sure you know

  • The IRB number
  • What report you want exported
  • What format you want
    • Excel raw (data as numbers, not words)
    • Excel labeled (data as words, but variable names that are really long)
    • SPSS
    • SAS
    • R
    • Stata
    • XML

The first request often takes longer since the Honest Brokers need to be added to the REDCap project before they can export. If you choose to proactively add them, you can speed the process a little.

Tip sheet

Video instructions/demo

LMS: MC SlicerDicer (00167193) (you'll have to search)

Go to ZOOM office hours at 2pm on Thursday

You can also request assistance here

If you wish to look at non-de-identified data prior to obtaining IRB approval for a study, you MUST obtain permission via a Review Preparatory to Research form.

Please note, as described in the form, there are very specific regulations associated with this activity to limit use.

Use of SlicerDicer for clinical purposes is not regulated by research entities.

We have a tip sheet for how to do that in PACE.

If this doesn't work for your needs, please contact the biostatisticians for support.

Follow these directions. (Coming soon!)

In the meantime please contact orthoresearch_help@duke.edu for more information.

 

Follow these directions. (Coming soon!)

In the meantime please contact orthoresearch_help@duke.edu for more information.

To request biostatistics assistance from the Biostats core, complete this form

If you are a trainee, you may also have your PI reach out to Dr. Cook for biostatistics support.

You may also request support here

You have three ways of getting your statistical plan reviewed.

1- Submit the Ortho New Research form. Dr. Cook will review the plan.

2- Consult with Dr. Cook for biostatistics support. Trainees, please have your PI reach out to Dr. Cook.

3- Consult with the Biostats core. To do so, complete this form.

4- If you're just overwhelmed, you can request support here

First, the biostatisticians should probably be co-authors with you, as you would add other collaborators.

Second, in your acknowledgments you should add

  • We wish to acknowledge support from the Biostatistics, Epidemiology and Research Design (BERD) Methods Core funded through Grant Award Number UL1TR002553 from the National Center for Advancing Translational Sciences (NCATS), a component of the National Institutes of Health (NIH). The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.

Important Note
You will have to submit the paper to PubmedCentral. Be sure to save all of your submission materials and contact nihpublicaccesscompliance@dm.duke.edu for assistance.

 

We have a talk about that, but the short response is, "Why wouldn't you collaborate with an expert?"

Biostatisticians are really helpful in the study planning, study analysis, and manuscript phases of a project. Get them involved early.

They need to know

  • Your hypotheses- but particularly your PRIMARY hypothesis.

  • Your protocol (subject identification and data collection/measurement methods).

  • Your dependent and independent variables.

  • Your deadlines/timelines

  • Publications similar to yours to help with context.

  • IF POSSIBLE: What is known about the mean and variance of those variables per previously completed/published work.

  • IF POSSIBLE: What you want the output to look like. In other words, what do you want on your tables and graphs? If you aren't sure, look at the other publications and see how they present the data.

There is training for everything. What training specifically is needed will vary. Below are the most common courses we answer questions about. For training specific to a study, contact orthoresearch_help@duke.edu

Requirements

  • Do this on your own.
  • Do it every 3 years.
  • Log in to https://www.citiprogram.org and under single sign on choose Duke RCR.
  • More detailed instructions are here

HOWEVER

If you are a faculty member, you may take the SCRI instead, as the SCRI will satisfy the RCR100 requirement. Note, the RCR100 does NOT satisfy the SCRI requirement.

Requirements

  • Do this as part of an approved group/class
  • Do this every 3 years
  • Take one of these participation required, full attendance required ZOOM classes.

If you don't attend the whole class or don't participate, you risk not being given credit.

Requirements

Requirements

  • Do this on your own.
  • Do it every 3 years.
  • Log in to https://www.citiprogram.org and under single sign on choose Duke Health.
  • More detailed instructions are here

If you completed CITI at a different institution, please don't create a new account. Log in to your old account and affiliate it with Duke. See the instructions for how.

Your question not answered here? Found a broken link? Email us orthoresearch_help@duke.edu