Clinical Research Update - September 2018

Wednesday, September 5, 2018
By Duke Office of Clinical Research (DOCR)

OnCore Community News
iRIS Community News
Research Community News
DOCR News
Did You Know?
Training Opportunities
Clinical Research Employee Highlights
Partner Resources


OnCore Community News

 

 
Reminder:  Don’t Forget to Push the “Sync Data Over Api” Button in iRIS
  1. In Section 700 Sponsor and Funding Source of the iRIS application, there is a Sync Data Over Api button
  2. Make sure you push this before you Save and Continue to Next Section
  3. If you forget or choose not to press the Sync Data Over Api button to send the study information to OnCore, you can still go back and push the button before you submit the application for PI signoff
  4. The sync button is available and will push study data into OnCore until IRB approval.  If you want the study in OnCore, PUSH the Sync Data Over Api button

If you do not push the Sync Data Over Api button, the protocol will have to be manually created in OnCore.  This will delay the ability to complete the other startup activities associated with moving the protocol through the institutional Approval process.

 
Common Terminology Criteria for Adverse Events (CTCAE) 5.0 Now Available in OnCore

The Common Terminology Criteria for Adverse Events (CTCAE) 5.0 has been added to production in OnCore.

End users will find CTCAE 5.0 in the drop down values and also as an option in reports and the PC Search.

No data has changed as a result of this addition, however it is now available for use if study teams have that need.

 

What is the Minimum Footprint Report?

The Minimum Footprint Report lists the minimum data that should be manually verified and entered into OnCore.  The report primarily represents protocol data and accrual information.

We need your help in assuring these data are accurate.  The Duke research portfolio should be reflective of all clinical research at Duke, including the number of participants accrued to Duke clinical studies.  We appreciate your efforts and believe this will be important for your research reports as it will reflect “real-time” enrollment.

 

OnCore Tips, Tricks, and Did You Know?

Visit this link for more information

 

 


iRIS Community News

 
 
Uploading Documents in iRIS

Please do not upload the following individual documents into iRIS:  Research Summary, Waiver, or Continuing Review Progress Report.  All of these are now embedded as part of the iRIS system and they are not separate Word documents any more, as they were in eIRB.

 

Clarification:  Uploading Revised Documents in iRIS

The IRB requests that study teams upload only a tracked version of an amended document (such as consent forms, phone scripts and advertisements) in iRIS.  In general, clean versions should not be uploaded.  The exception to this is sponsor-generated items like sponsor protocols and Investigator Brochures, when red-lined versions are sent, still need clean copies provided.    

In general, amended documents should replace the original document that was approved.  To do this, create a revision of the approved document, check it out, track the changes that you are making with the amendment, and check back in the tracked document.  Remember to save changes.  

The Tip Sheet for How to Revise an Existing Study Document can be found on the DOCR web site.

 

iRIS:  Error Message 500—Internal Server Error

If you are getting the message “Error Message 500 – Internal Server Error” in iRIS when trying to open a document, check the filename of the document.  Filenames of all documents have a character limit of 250 characters and if a filename is too long, the error will be caused.  Shortening the length of the filename seems to resolve the issue.

 

iRIS:  Continuing Reviews and Amendments

Please do not submit Amendments in iRIS during the time a Continuing Review is in process.  Doing so will cause versioning issues and may lead to a delay in processing both the Amendment and the Renewal.  If you have an urgent Amendment during the time your Continuing Review is in process, please contact your IRB Specialist for assistance: https://irb.duhs.duke.edu/about-us/staff-and-chairs

Also, it is important that study teams do not start/submit an amendment to their study prior to the study’s migration amendment being approved by the DUHS IRB.  The only exceptions to this are the submission of safety events and key personnel changes.  Submitting safety events and key personnel changes for a study should be done in real time.

If you submit an amendment prior to the study’s migration amendment being approved, the IRB will withdraw the amendment submission and the study team will need to resubmit the amendment once the migration amendment has been approved.

 

iRIS:  Consent Forms

All consent forms in iRIS should use the Microsoft extension .doc.  The extension .docx is not compatible for watermarking in iRIS, so please change consent form files to .doc before submitting to the IRB.  Note that when you change the file from .docx to .doc, some formatting changes may result.

Use the consent form templates available on the IRB web site when you have to create new consent forms for your study.  See DUHS Sample Consent

 

iRIS:  Revising a Document in iRIS

If a document is already in iRIS and you want to revise it, create a revision of the existing document, instead of uploading a new document.  This will help to reduce the clutter of so many document versions in iRIS.  The only exception to this is when the document you want to revise has not yet migrated over from the old system (eIRB).  In that case, get the document you want to revise out of eIRB and upload the revised version in IRIS (and submit an amendment).

 

iRIS:  Name of IND/IDE Holders

Please be sure to name the IND/IDE holder specifically in the IRB application.  In iRIS, the IND/IDE holder question forces the user to make a generic selection, but there is a text box below that question (asking to provide details) to enter text and name the holder specifically.  Also be sure to give the drug or device source and IND/IDE Number.  See the screenshot below:

 

iRIS:  Key Personnel Changes

Except for PI changes and changes to Outside Key Personnel, all Key Personnel changes should only be made using the KSP Change Form in iRIS.  Any Key Personnel changes that are made when you are doing a regular amendment will not be documented specifically on the IRB approval letter.

 

Coming Soon:  iRIS Integration in myRESEARCHhome

In the coming weeks, the IRB tab in the myProjects widget of myRESEARCHhome will be refreshed, pulling data directly from iRIS. The widget will contain the short title, protocol number, and expiration date for all active and approved protocols in iRIS where you are listed as Key Personnel. There will be quick links to both iRIS and the eIRB so you can view more information in either system.

 


Research Community News

 

Maestro Care Provisioning for Internal Transfers

Maintaining Maestro Care’s security is a critical component of caring for our patients and their loved ones.  It is also essential that staff communications within Maestro Care accurately identify the staff’s credentials and role.    

To ensure this happens, there will be a change to how employee transfers are managed.  When a staff member transfers from their current position, their current Maestro Care access will be disabled effective upon the SAP transfer date.  The staff’s new manager (or designee, as each entity/department processes Maestro access requests) will be required to request Maestro Care access appropriate to the new position by submitting a request via the Service Catalog located in Service Now.   MC Access for Physician and Advanced Practice Provider will not be affected by this change.

This change was effective for all transfers that occurred on or after September 1, 2018.

 

Individual Patient Expanded Access IND Service Update

Physicians can request an Individual Patient IND when a patient has a serious or immediately life-threatening condition and their physician believes he or she may benefit from a drug that is not FDA approved. Since August 1, 2018, twenty-eight Duke physicians have utilized the Individual Patient Expanded Access Investigational New Drug (IND) service sponsored by Duke University Health System (DUHS). This service, which aims to relieve physicians of administrative burden, utilizes School of Medicine resources to support regulatory filings required under FDA’s Expanded Access Program. The Office of Regulatory and Quality (ORAQ) assists with obtaining approval from the drug company and submitting the IND to the FDA, while a core of regulatory coordinators processes the IRB application.

To date, twenty-two Individual Patient INDs have been processed. Physicians who utilized this service and completed a satisfaction survey all strongly agreed that:  their patient was able to access an investigational drug faster; there was a positive impact on their clinical role, and that they would recommend this service to a colleague.  One physician stated: ‘The entire experience was outstanding. There was excellent communication throughout the process, and questions were answered rapidly. Paperwork was expedited throughout the process, allowing my patient to gain access to the investigational drug much faster than I expected.’

Please utilize the link below to request free assistance with submission of an Individual Patient Investigational New Drug (IND) application: Individual Patient IND Application Service.  The physician will be asked to input brief clinical data and key staff will be notified of the request. The requesting physician will be informed of progress via automatic email notifications. For questions or more information, please contact ORAQ (ORAQ@duke.edu) or DOCR (DOCR-jobs@duke.edu). 

 

Revisions to IRB Pregnancy/Contraception Guidance

In an effort to revise outdated language from the perspective of both science and autonomy for subjects, and to accommodate new regulations and recommendations that require more research-specific consideration of benefits and harms of specific approaches to minimizing reproductive risks, the DUHS IRB has revised their pregnancy/contraception guidance.  This new approach is based on general principles rather than hard and fast rules, recognizing that every study will be unique in terms of:

  • Underlying probability of pregnancy in specific population
  • Potential risk to a developing pregnancy from study-specific exposures
  • Relative benefit (improved negative predictive value) vs harm (false positives) of serum pregnancy tests compared to urine pregnancy tests
  • Relative benefit (reduction in pregnancy probability ) vs harm (impact on current sexual functioning, side effects of specific method in specific condition) of different contraceptive methods

Recommendations:

Consent Addendum
For protocols where a pregnancy is very unlikely based on the age distribution and condition (like most Phase I cancer studies), that the reproductive language be a separate consent addendum, rather than part of the main ICF.   The rationale is this (a) reduces the burden on most subjects (and study staff) and (b) allows a little more description/discussion in those settings where subjects might have to change their current methods/practice and should consider that in their decision to participate.    These potential advantages of a separate addendum for a specific protocol should be balanced against any operational considerations.

Pregnancy Testing
Specific criteria about when to use serum vs urine testing are not feasible.  The decision should be made both on the risk of the study exposure, the risk of pregnancy in the study population, and the risk of a false positive or indeterminate serum result (not uncommon in women in their 40's or early 50's).   For additional information, see the recent CTTI guidance (https://www.ctti-clinicaltrials.org/projects/pregnancy-testing).

Female Contraception
Approved methods are based on the level of desired effectiveness.   "Highly effective" is 99% or more, which would include vasectomy, BTL, IUDs, or hormonal implants alone, or another hormonal method AND barrier + spermicide.  "Effective" is 85% or more, which is all of the above plus other hormonal methods alone or barriers + spermicide.    Abstinence is also explicitly OK.   Specific methods may be contraindicated in some study populations (e.g., combination birth control pills in patients at risk of thrombosis).    The CDC Medical Eligibility Criteria for Contraceptive Use provides resources for method effectiveness and contraindications (https://www.cdc.gov/reproductivehealth/contraception/mmwr/mec/summary.html)

Male Contraception
The sponsor protocol needs to specify why male contraception is required.   If it's because of concerns about genetic damage, then, depending on level of effectiveness required, any of the above methods are fine.   If it's concern about transmission of drug through semen, then condoms are required at all times, even if the patient has had a vasectomy, and there are some additional things regarding other types of sex that may need to be added.

For additional information, see the August 22nd Research Wednesday recording of Dr. Evan Myer’s presentation “Revisions to IRB Pregnancy/Contraception Guidance”.

 

Research Data Storage Plan (RDSP) Reminders

Here are some helpful tips from the Information Security Office when filling out the Research Data Storage Plan for a study:

  • Only RDSPs that were approved in which the IRB was also approved moved over in the data migration. Make sure your RDSP did not move before starting a new record.
  • If you need to amend an existing RDSP and do not have edit rights, contact the listed submitter or the security office – Shelly Epps – to start the amendment and give you edit rights, after which you must fill in all fields, change the CRU back to yours and save – at which point it will route for review.
  • When you enter RDSP, you must use the full IRB protocol number (e.g., Pro00011111 rather than just the number – 11111).  Also remember that the protocol number is an 8 character number, even as we’ve passed the 100K mark (e.g., Pro00100000, not Pro000100000).   The system matches against the full IRB number and we are currently deleting many duplicates due to staff entering partial or incorrect IRB numbers.

 

Subject Initials in De-Identified and Limited Data Sets

Subject initials may not be included in de-Identified data sets because the relinking criteria states the re-identification code "is not derived from or related to information about the individual…" [45 CFR 164.514(c)(1)].  A Limited Data Set (LDS) may include subject initials because the re-identification section for de-identification does not apply.  Instead, a LDS relies on the Data Use Agreement to provide appropriate protections against re-identification. 

Bottom Line:  De-identification = No Initials.  Limited Data Set = Initials OK.

 

Save the Date:  Managing Issues that Matter for Sites and Sponsors/CROs Post-GCP E6 (R2)

The local chapter of ACRP is hosting a program to identify and discuss the expectations of managing clinical trials, specifically after the finalization of ICH E6 (R2).  Sandra SAM Sather will present this session on Monday, September 17, 5:30 PM – 7:30 PM at Mez Contemporary Mexican in Durham.  For additional information contact office@acrpnet.org.

 

Funding Opportunities from CTSI 

Duke/UNC CTSA Consortium Collaborative (Deadline: October 11, 2018)

  • Up to $25,000 per institution ($50,000 total)
  • Purpose: Develop inter-institutional collaborations for new investigator teams conducting novel clinical and translational research that applies or accelerates discovery into testing in clinical or population settings.
  • More information and application details

 

Duke/NCCU Collaborative Translational Research Grant (Mandatory LOI due: September 15, 2018)

  • Up to $25,000 per institution ($50,000 total)
  • Purpose: Develop inter-institutional collaborative research projects between Duke and North Carolina Central University researchers.
  • More information and application details

 

Duke CTSI Special Populations Pilot Agreements (Mandatory LOI due: September 17, 2018)

  • Up to $25,000
  • Purpose: Facilitate research that promotes health equity for groups who have traditionally been under-represented in health research or excluded altogether.
  • More information and application details

 

Duke/Stanford CEC Summit 2018

An exciting new clinical events classification and safety meeting is taking place September 26th -27th  in Chicago, coordinated by the Duke Clinical Research Institute and the Stanford Center for Clinical Research.  Designed for academic and industry thought leaders involved in adjudication, the two-day symposium promises to deliver provocative and challenging discussions on trends in the industry and the development of CEC/safety best practices, strategies, and quality standards.  For additional information and to register:  https://dcri.org/our-work/trial-support-services/cec/cec-summit/

 

Duke Institute for Health Innovation Request for Applications 2019

DIHI is excited to announce the next emerging ideas and innovation funding cycle for demonstration pilots. Proposed innovation projects should address actual and important problems encountered by care providers, patients and their loved ones, and represent urgent health challenges nationally. For the upcoming funding cycle, DIHI is specifically interested in problems and solutions that are aligned with the following thematic areas:

  • Preventing healthcare-acquired infections and enhancing quality and safety
  • Population health and analytics
  • Building resilience and well-being
  • Enhanced transitions of care
  • Novel patient interactions (engagement, education & experience)
  • Team-based and new care models

Please visit www.dihi.org/funding for additional information and instructions. The deadline for submitting applications is 6 pm Friday, September 28, 2018. All proposals are required to have a DUHS operational lead as a co-sponsor to be accepted for review. If the DIHI team can be of any assistance in the formulation of ideas or connections, please contact Suresh Balu. We look forward to your innovative solutions.

 

Save the Date:  Basic Science Day

Basic Science Day, a celebration of Basic Science Research at the Duke University School of Medicine, will be held on Wednesday, September 12, 2018 from 9 AM – 5 PM in the Trent Semans Center Great Hall.  This year’s event will feature James A. Spudich, PhD, speaking on “The Myosin Mesa and Hypertrophic Cardiomyopathy:  Mutations to Mechanisms to Therapies”.  For additional information and to register:  https://medschool.duke.edu/research/basic-science-research/basic-science-day

 

Duke Digital Health Week

The inaugural Duke Digital Health Week will be the crossroads at which health, tech, business and the social sciences at Duke meet. Mobile technology and wearables are empowering patients and caregivers with data, and with the introduction of artificial intelligence, virtual reality and telemedicine into the clinician's tool bag, the way we experience healthcare is rapidly changing. As the use of digital health technologies expands, we ask, what's in store for the future of health?

The Duke Mobile App Gateway is bringing together experts from Duke Health and Duke University together with patients, families, students, and the curious. We want to include everyone with an interest in the future of healthcare in the conversation; we'll share ideas, new findings, best practices, tools, and raise questions. Come imagine the future of Digital Health.

When:  Monday, September 17th - Thursday, September 20th
Where:  Various locations around Duke
For more information and registration:  bit.ly/DukeDHWeek2018

 

Save the Date:  Keeping the Heart Young:  The Science of Cardiovascular Resistance, Resilience and Rejuvenation

Translating Duke Health will be hosting this daylong event Saturday, October 6, 2018, 8 AM – 3:30 PM.  The event will bring together national experts in Cardiovascular Disease to address the science of keeping the heart young.  For more information and to register, visit the School of Medicine website.

 

Save the Date:  2018 Clinical Research Appreciation for Faculty and Staff

The 2018 Clinical Research Appreciation for Faculty and Staff, sponsored by the Duke Office of Clinical Research, is scheduled for Tuesday, October 16th, 11:00 AM – 1:30 PM, Trent Semans Center Great Hall.  This drop-in event is open to all faculty and staff involved in Clinical Research at Duke and will feature informational tables from Clinical Research Administrative groups and Partners as well as food, music, dancing, and door prizes.

 

Save the Date:  Technologies and Innovations in Human Immunology

Translating Duke Health Immunology & Transplant Initiative will be hosting a half day event Friday, November 2, 2018, 8:00 AM – Noon.  The event will acquaint the Duke research community with ongoing intramural research efforts in the field of human immunology with the goal of bringing together new collaborations and identifying opportunities for future projects.  For more information and to register: https://duke.qualtrics.com/jfe/form/SV_5hUsrABzCmArMCp.

 


DOCR News

 

DOCR Maestro Care Services for Research Recruitment and Study Conduct

Maestro Care tools are available to assist with your study needs. 

  • Custom reports to identify patients that meet your inclusion/exclusion criteria
  • Custom columns for the patient schedule or patient list that display information about your study
  • A Page, E-mail, and a Maestro Care In Basket Message to notify you of potential participants
  • Direct contact with potential patients through MyChart Research Invitations
  • Possibility of using a provider facing Research Recruitment Alert (Best Practice Alert – BPA)

For more details on any of these Maestro Care research recruitment and study conduct tools or to request someone talk with you about a specific project, please follow this link. 

https://duke.box.com/s/16f3fb0fdu70r62ygk63zmthsmb8wbic

 

REDCap Day

The Duke Office of Clinical Research invites you to join us for REDCap Day on September 26th from 10 AM – 4 PM in the Trent Semans Center Great Hall.

This is a chance to learn more about REDCap and what it can do for your research. The keynote speaker will be Rob Taylor, the lead REDCap developer from Vanderbilt, to talk about what is new and next for REDCap.

All skill levels invited.

Please register here to let us know you plan to attend. We look forward to seeing you there!

 


Did You Know?

 

 
REDCap:  Marking HIPAA Identifiers

To avoid delays when moving a project to production or requesting post-production changes, make sure that all HIPAA identifiers are marked.  Mark identifiers quickly by clicking on Check For Identifiers, and checking the fields that should be marked. 

This updates the project without having to return to the Online Designer.

 

Need a MRN in Maestro Care?

To request Registration/Medical Record Number for “new to Duke” participants in Maestro Care, please contact HIM via email, HimdataIntegrity@dm.duke.edu, or calling, 919-684-5525. Please provide the following information:   

  • Name
  • DOB
  • Gender
  • Address
  • Phone Number

 


Training Opportunities

 

Upcoming DOCR Training Offerings

DOCR training offerings are available in the Duke LMS. There are 2 easy ways to find all DOCR classes: Enter “DOCR” in the search field and click Search, or click the Category link, and then click the DOCR link. The results display all the offerings currently available from DOCR. Hint: If you want to bookmark the Duke LMS in your browser, edit the bookmark to this address: https://lms.duhs.duke.edu/Saba/Web/Cloud

Detailed information about each offering and direct links to the offering are also available on the DOCR Course Listing.

 


Clinical Research Employee Highlights

 

The School of Nursing welcomes Dr. Eun-Ok Im as the role of CRU Director.  Dr. Eun-Ok Im received her PhD in nursing from UCSF in 1997 and had 1.5 years of postdoctoral study at UCSF. Dr. Im has gained national and international recognition as a methodologist, theorist, and researcher in international cross-cultural women’s health through a series of NIH funded R01 studies (4 R01s as the PI) and other grants (over 25 small grant studies as the PI). She has published more than 350 papers, abstracts, and chapters (over 170 refereed journal articles) and over 300 international and national multi-disciplinary presentations. Dr. Im has been on more than 47 research review panels of the NIH (for over 14 years), and was also a reviewer for the PCORI and the American Heart Association. 

The School of Nursing CRU welcomes Rita Masese as a CRC.

The Department of Medicine CRU announces the following staff news:

  • Carolyn Chang promoted to CRS, Sr. in ID
  • Bobby Warren promoted to CRC in ID
  • Mimi McCarty joined GI as a Regulatory Coordinator
  • Kate Frankey promoted to CRC, Sr. in CAGPM
  • Gladwell Mbochi promoted to RPL in CAGPM
  • Nicole Pavlus joined GI as a CRC
  • Robin Gilliam joined Nephrology as a CRC
  • Monica Guy joined Pulmonary as a CRC
  • Erika Coleman was promoted to CRC in Pulmonary

 


Partner Resources

 

 

DUHS Compliance Office Newsletter

Catch up on news from the DUHS Compliance Quarterly Newsletter.

Subscribe to the Clinical and Translational Science Institute (CTSI) Bi-Weekly Newsletter

Stay up to date on news, funding, and education opportunities in translational science at Duke by subscribing to CTSI UPDATES. Read past newsletters and subscribe at https://www.ctsi.duke.edu/news/newsletters.

 

To be added or removed from the distribution list for the DOCR Clinical Research Update newsletter, please contact the DOCR at docr.help@dm.duke.edu.