Duke Clinical Research Update May 6 2020

Wednesday, May 6, 2020
This image is the Duke Clinical Research Update Banner

 

 

 

 

 

 

 

 

 

SUPPORT OFFICE HOURS

REDCap Office Hours

 

Email redcap-docr@duke.edu to schedule a virtual session at one of the times indicated below.
Tuesdays 10 AM, virtual sessions
Wednesdays 10 AM, virtual sessions

Thursdays 2 PM, virtual sessions

Fridays 10 AM, virtual sessions

 

SlicerDicer Office Hours

Thursdays, 1 PM, via WebEx

 

PACE Office Hours

Every other Tuesday, 1 PM, via WebEx.  Click for information.

 

RESEARCH COMMUNITY NEWS

 

External Monitoring Policy Extended to June 30th, 2020

The External Monitoring Policy has been extended to June 30th, 2020.

The purpose of this policy is to clarify for research personnel and sponsors Duke’s external monitoring policy in response to the COVID-19 epidemic.

Duke University aims to assure the safety of the local community paramount during the COVID-19 outbreak and is taking a number of steps to mitigate the risk of community spread. 

For clinical trials, Duke School of Medicine is postponing all in-person monitoring visits and scheduled sponsor meetings until June 30, 2020 due to circumstances related to COVID-19 that are beyond our control.  At that time, this policy will be reassessed.

The full text of the External Monitoring Policy is available on the DOCR website.

 

When Transferring Data or Samples to External Entities or Persons

The IRB does not need signed copies of contracts/Material Transfer Agreements (MTAs)/Data Use Agreements (DUAs) to be uploaded in iRIS for transfers of data or samples.  Rather, the research summary in your IRB application should include language indicating the expected transfer, what data/specimens will be transferred, and entities/persons involved in the transfer.  For example:

 

“The study team at Duke will transfer de-identified data to Johns Hopkins for external analysis once appropriate agreements between Duke and JHU have been fully executed.”

 

Likewise, study teams do not need to upload external vendor agreements or releases, particularly when sending de-identified samples for analysis.  Instead, include this sentence in your research summary in iRIS:

 

“No samples will be sent for external analysis until appropriate agreements between Duke and the vendor have been fully executed.”

 

Please check with your IRB Specialist if you have any questions:  https://irb.duhs.duke.edu/about-us/staff-and-chairs  

 

COVID-19 Outbreak and Consenting Research Participants at Duke

Duke School of Medicine and the DUHS IRB are issuing the following statement regarding the COVID-19 outbreak as it affects consenting research participants at Duke.  This policy is posted on the IRB’s homepage and can be found in the below links.

https://irb.duhs.duke.edu/node/4722

 

https://irb.duhs.duke.edu/about-us/irb-news/covid-19-and-consent-research-duke

 

Included in this policy is a change in initialing practices on the bottom of consent forms.

 

Study teams may now forego obtaining initials on the bottom of every page of the consent for COVID patients or possible COVID patients, in order to reduce the amount of handling of the consent document.  This applies only to studies with direct patient contact for consent, and it only applies to the initials in the footer, nowhere else. 

 

Study participants for these studies need only provide a signature and date on the last page of the consent AND complete any portions of the consent form that require initials for opt-in (such as storing specimens for future use).

 

Study teams implementing this practice are encouraged to keep a copy of this communication with the study record for future documentation purposes.

 

If you have questions, please contact your IRB Specialist:  https://irb.duhs.duke.edu/about-us/staff-and-chairs 

 

New Online Course:  Remote Consent for Clinical Research

DOCR has created an online course for conducting consent activities remotely. This new course provides both resources and tips for consenting clinical research participants remotely.

 

The first lesson addresses conducting remote consents during the COVID-19 pandemic. The rest of the course provides information on policies and processes that apply under normal operations.

 

DOCR Remote Consenting Course

 

If you have questions about remote consent and your options, the following are great resources:

 

Training Video on Central Data Repository eConsent in REDCap for COVID-19 Studies

With many participants being consented to COVID-19 related studies, Duke has created a Central Data Repository for studies. eConsent is available for the Central Data Repository in REDCap.

 

A short training video has been created to help with this process. It is four minutes long and covers how to access the CDR eConsent in REDCap, creating a new record, and eConsenting in-person.

 

Check it out on the DOCR COVID-19 resources page or via direct link here!

 

Adobe Sign Training for Clinical Research

Adobe Sign is a secure, cloud-based app that you can use to assist with operational documents requiring internal Duke employee signature or a signature from an employee at a collaborating study site or with a vendor/sponsor with whom we have a formal business relationship. Use a modern browser to prepare, send, sign, track, and manage signature processes. No software is needed for signers (who can be internal or external to Duke, provided no PHI is being sent).

 

If you need an account please complete the following items

Step 1: complete the training listed below

Step 2: email DOCR.Help to request an account

 

Adobe Sign Training for Clinical Research: This training is intended for clinical research personnel at Duke who will request access for Adobe Sign from the Duke Office of Clinical Research. Learning Objectives: (1) Define adobe sign (2) Describe how you can and can't use Adobe Sign (3) Differentiate between e-signatures and digital signatures (4) Find tools and resources

 

COVID patients and IRB Data Disclosure Forms

In an effort to limit exposure of staff and also avoid bringing potentially contaminated materials out of the hospital room/living quarters of a COVID participant, CRCs may utilize the telephone visit box option when completing an IRB Data Disclosure form for participant payment.  Clinical Research Coordinators should document the circumstances related to the visit and that the participant did not sign due to COVID. 

 

Employee Travel & Reimbursement is aware that they may see this notation on the IRB data disclosure forms. 

 

Please remember for those participants who have a LAR who is not high risk, that person could also sign the form.

 

Maestro Care and Signing of Verbal Orders

A new initiative across Duke Health began on January 24, 2020 that places charges on hold for verbal orders until the orders are signed by the provider. Duke Health has a Verbal Orders Policy Workflow to comply with regulatory requirements for authentication of verbal orders. Timely cosigning of orders is important for ensuring proper reimbursement to Duke Health for services rendered.  Our policy requires these orders to be signed within 48 hours of being issued.  Charges associated with verbal orders will be placed on hold until signed by the provider. When pending verbal orders are authenticated, all associated charges will be processed for release.  To access and review the Verbal Orders Policy Workflow please click here.

 

For tips on how to sign, reassign and decline verbal orders, please access and review the Cosigning Orders Made Easy tip sheet here.

 

Study Review Project is Underway

In an effort to collect information regarding current study activity, a group of individuals from DOCR and OARC will be reaching out to study teams individually to ask a few brief questions.  The information collected will be used to assist SOM leadership with clinical research roll back planning.  The topics addressed will include remote clinical research activities, OnCore data and IRB deviations under COVID. These calls should be brief, less than 10 minutes.  We will be starting with studies which are either On Hold or Suspended and will then move to Tier 2 and Tier 3 studies.  We greatly appreciate your cooperation in collecting this data in a timely manner.  This information is vital to our planning. If you have any questions or concerns please contact Catee Mullen at catee.mullen@duke.edu

 

Annual Performance Evaluation of Clinical Research Personnel:  Research Oversight Standards

Please do not forget that the annual performance review component, formerly known as the R06, was updated late last year to align with new clinical research management systems and research competencies.

 

The updated Research Oversight standards (R07) are posted to the DOCR website within the policy for Annual Performance Evaluation of Clinical Research Personnel. The general sentiment of these standards has not changed; however the wording has been updated to reflect contemporary systems and uniform research competencies. Please see the R07 standards below.

 

 

Evaluation of performance of job responsibilities E, S, NI

Research Oversight (RO7):  E   S  NI  NA  

 Research Operations – Understands and applies regulatory and institutional policies, processes, and procedures.(example: clinicaltrials.gov reporting, DOCR startup process, SIP console, RDSP)

 Research Operations – Follows all DOCR policies  including Minimum Footprint, Participant Status and Study Visit Documentation in OnCore (link)

 Safety and Ethics – Submits IRB initial applications, renewals (link), amendments, adverse events, deviations, and/or RDSPs in an accurate and timely manner.

 Data – Complies with CRU CQMP and QA activities (internal audits, study monitoring, safety reporting, consent reviews, responds to financial reports and requests etc.)

 Scientific Concept – Assists with or contributes to the development of protocols, grants and/or manuscripts

 Site and Study Management – Maintains current enrollment logs or summary accrual on all consenting studies in OnCore.

 Leadership and Professionalism – Regularly attends required department meetings; successfully completes designated/required training (CRU, Research Wednesdays, Town halls, RCR trainings, CITI modules, Maestro Care, IRB/iRIS, OnCore, etc.)

 

These standards should be used for Clinical Research Coordinators, Clinical Research Nurse Coordinators, and Regulatory Coordinators PEPs this year.

 

A guidance document, containing related reports and metrics has also been created to assist managers in their evaluation; Procedure:  CRU Guidance for Annual Performance Evaluation of Clinical Research Personnel.

 

 

eGRC to Receive Workflow Updates on Thursday, May 7

The DHTS Information Security Office, Compliance team will be performing a workflow update to the eGRC application on Thursday, May 7, at 5:30 PM.  

 

Users of the Research Data Storage Plan (RDSP) module will see a change in functionality as was noted in the recent RDSP training update for Reviewers and Staff.  If you are logged into RDSP at the time of the update, you may be logged out without notice so save your work and log out of RDSP before 5:30 PM. 

 

If you have any problems after the upgrade, please contact the DHTS service desk at 919-684-2243. 

 

If you were unable to attend the Research Data Storage Plan training session, use the link below to view the session recording.

 

RDSP Staff Training Update

 

Cybersecurity:  Impersonation Attacks on the Rise

Duke’s IT security offices are issuing a warning to the Duke community after a sharp increase in email impersonation attacks targeting staff and faculty.

 

In the past week, attackers have impersonated at least 15 Duke faculty members, sending more than 1,200 phishing emails to Duke users. The impersonated faculty came from a wide range of units and departments, including Law, Nicholas School of the Environment, Computer Science, Surgery, Ophthalmology, Economics, Biology, Chemistry, African and African American Studies, Art, Art History and Visual Studies, and Asian and Middle Eastern Studies.

In these phishing scams, attackers set up an email address outside of Duke (such as Gmail) that appears to be a personal email account for the Duke faculty or staff member they are impersonating. The attacker then sends targeted messages to users who may work in the same department as the impersonated faculty or staff member.
The messages often begin with a simple request such as, "Are you available?" If a user responds, the attacker will ask for money to be transferred or for gift cards to be purchased and the activation code provided via email.

In the most recent attacks, several Duke users responded to the phishing scams and purchased about $1,300 in gift cards.

 

If you receive such an email and are asked to purchase gift cards or asked to transfer funds via wire, please do not respond, and report the issue either using the Report Phish to Duke button or by contacting security@duke.edu or your IT support.

 

Virtual Town Hall:  Maintaining Clinical Trial Momentum During COVID-19 and Beyond

Join industry innovators Craig Lipset and Aaron Fleishman for a virtual town hall to discuss maintaining clinical trial momentum during COVID-19 and beyond.

Thursday, May 14, 2020 - Noon ET 

Submit your questions in advance, as they
will drive the conversation! 

Gain insight into overcoming patient enrollment and engagement challenges while supporting study continuity. Learn how to minimize clinical trial disruption with solutions for all stages of study activity – planning, enrolling, and even restarting.

Click here to register.

 

Registration Open for the International Science of Team Science Virtual Conference—June 1-4, 2020

On behalf of the SciTS 2020 Conference Planning Committee, the International Network for the Science of Team Science (INSciTS), Duke University, and the Duke Clinical & Translational Science Institute, we are thrilled to invite you to join us for a lively and robust virtual meeting of the Science of Team Science community!

 

Duke affiliates can access the entire 4-day conference for free with discount code: DUKEZERO

 

As the leading international conference for the Science of Team Science, SciTS 2020 will focus on highlighting and pursuing excellence in studying, doing, and teaching team science. We are proud to present an online program that features world-class scholarship, case studies, and evidence-based practices in support of these themes.

 

Register now for the SciTS 2020 Virtual Conference.

 

Clinical Research Training Program Accepting Applications

The program is now accepting applications for academic year 2020-2021. For a detailed description of the program, the course offerings, and a link to the online application, please visit the CRTP website at http://crtp.duke.edu.

 

This year CRTP is launching the Basic Science Research Track (BSRT), a customized curriculum designed for physician scientists and trainees leading to a Master of Health Sciences in Clinical Research Degree. 

 

The application deadline for priority review is May 15, 2020. Applications will be accepted through August 1, 2020.

 

IRIS/ONCORE UPDATES

 

NEW Management Groups Available in OnCore Related to COVID-19

The INSTITUTIONAL APPROVAL NOTIFICATION was recently modified to include the COVID UPDATE below requiring action. 

 

**COVID UPDATE: Please make sure all studies have the COVID study or appropriate Essential Study Tier selected as a Management Group in PC Console >  Main > Management tab. Definitions for Tier 1, Tier 2, and Tier 3 Non-Essential studies can be found at the following link under the FAQs for Essential studies: https://research.duke.edu/covid-19-human-subjects-clinical-research  COVID studies do not need one of the Tier management groups. 

 

  • COVID Study = The study involves COVID-19 research
  • Tier 1 Essential Study = High Potential Direct Benefit
  • Tier 2 Essential Study = Moderate Potential Direct Benefit  
  • Tier 3 Non-essential Study = Primarily observational or behavioral studies, surveys, focus groups, retrospective studies, archival data/sample-based research studies.

This image shows the OnCore categories listed above

 

OR

Image shows the COVIS-19 selection option in OnCore

 

***  NOTE:  You must allow pop-ups to edit the Management Group

 

OnCore Deep Dive and Refresher Session Scheduled for May 29, 2020

Please plan to attend the OnCore Deep Dive and Refresher Session via WebEx on May 29, 2020 from 2:00 PM - 3:00 PM.   This session was recently rescheduled from May 22nd given the holiday weekend.  

 

These sessions are designed to offer you the opportunity to learn and apply useful information, workflow optimizations, and discuss topics of interest to the OnCore user community. Presenters for each session will consist of members of the OnCore Team and others experts from the research community.

 

We welcome all OnCore users to these sessions regardless of to your role or level of mastery in OnCore.  Chances are that someone else has the same questions or faced the same challenges that you have experienced using OnCore.  Attending the OnCore Deep Dive and Refreshers will provide advice and  guidance to maximize your OnCore exposure.

 

If you have specific questions or topic suggestions, please submit them to docr-training@duke.edu.

 

 

iRIS Submission Form Clean-Up

With the most recent iRIS release on January 17th, 2020, we implemented a new feature that stops study teams from adding multiple applications to one protocol, either during Initial submissions and or Amendment submissions.  This will prevent downstream issues for both the review boards and researcher, where in the past, there has been confusion regarding the most recent approved application due to the problem of multiple versions being under review simultaneously. 

Upon implementing this new feature, we discovered an issue which is now preventing study teams from submitting amendments to the IRB when draft forms were created on or before January 17th, 2020.  This is occurring because the system is finding draft forms that are still outstanding with the application attached. *Note: This does NOT impact any form created after January 17th, 2020.   Also, there are some protocols which have multiple Initial Submission Packets, which also contain the application, preventing further submissions.  Users may open the amendment page and find the message seen in the screen shot below:

This image shows the iRIS System Amendment closure request

 

*Note: Users may also see a statement that states, “Unable to Add a New Form until the following form (s) have completed board processing: Initial Submission Packet Form (version number).”

 

Issue Resolution

We have been working diligently with iMedRIS and the IRB to resolve this issue permanently.  In order to allow for submissions on the impacted studies, iMedRIS will perform a clean-up to remove any draft created anytime on or before January 17th, 2020.  Moving forward, due to the enhancement that was implemented in the latest release, this issue will no longer occur, because study teams must submit and/or delete any draft forms before iRIS will allow another form to be generated

What do I need to do as a researcher?

As we move forward with the next steps in conducting the system-wide clean-up, we will need full participation of each study team.  Below outlines information that will aid in this clean-up to ensure data integrity of all studies.   

*Submit ALL outstanding Amendments created on or before January 17th*

Study teams who have amendments in draft that were created on or before January 17th, 2020 will need to submit the most recent pending amendment to the IRB.  If your amendment is incomplete or is awaiting additional information prior to submitting to the IRB for review, (for example, you are awaiting additional information from your sponsor, PI, etc.), please answer all questions (regardless of accuracy) and submit the form for processing. 

What if there is an Initial Submission Packet that is restricting my Amendment submission?

If you are being restricted from submitting due to an unwanted Initial Submission packet, STOP!  The study team will not need to perform any action in these cases.  iMedRIS will perform the required steps to remove these duplicate packets from your protocol. 

What if I do not have a submission in progress, but need to submit one to the IRB during the clean-up?

The clean-up will be completed during non-business hours. Therefore, if you are submitting a new amendment, you will not lose your work and the submission should follow the normal workflow. 

Important Note:  Entire studies will not be removed, only the amendment forms, Initial Submission Packets, and Migration Amendments that are in draft causing an issue.

What if I do not submit my draft amendment in time to the IRB?

If the study team fails to submit amendments that are in draft and were created prior to January 17, 2020, the data will be removed from the user interface and no longer be able to be recovered.  Users will have to re-create their amendment and submit to the IRB for review.

Will I lose data in my attached application if my amendment is deleted during the clean-up?

If the user selects the ‘Save’ or ‘Save and Continue’ button within the application, the current version will store all data and remain in the system for reattachment in new amendment form submissions. If you have any consent forms or documents attached, please save the documents to your local drive as these documents will be lost should your amendment be removed during the clean-up.

 

iRIS:  How to Delete a Draft Study

There are instances when study teams need to delete draft protocols from iRIS.  There are two conditions which will allow a user to delete a study:

  1. The study MUST be in Draft status
  2. If you are the study author, you will have access to delete the study, which will remove this from the protocol dashboard for all listed key personnel.

As an important reminder, if the study has been withdrawn by the IRB, users should NOT delete these studies.  Instead, please ‘Hide’ the study using the Hide icon:

This image shows the hide icon

This is user specific and will need to be applied on each user’s protocol dashboard. 

This image shows the iRIS protocol dashboard

Fig 1. Delete icon is available to Study Author

 

In order to identify the study author, please open the protocol and navigate to the protocol application screen.  Once you have done so, the study author will be listed beneath the ‘Created By’ column as show below.

This image shows the iRIS protocol dashboard

              Fig 2. The study authors name will be listed in the created by field

 

IRIS Tip - What to do when your DUHS IRB Application is noted as “Incomplete”

Sometimes, when you create an edit of your DUHS IRB Application form, if you use the Back button or some other method to leave the form, it will be noted in the iRIS system as ‘Incomplete’. So long as it is ‘Incomplete’, it cannot be successfully included as an attachment in another iRIS submission.

 

This issue most commonly occurs when one is responding to a Modification Request from the IRB, though it may also happen in other contexts. In the example screenshot below, a Modification Request involved needing to update the IRB Application. After one makes the requested edits to the Application, it is natural to think one can just save the section, then use the Back button to return to the Modification form. While this is OK to do as one goes back and forth between the Application and the Modification form, it may result in the IRB Application being noted as ‘Incomplete’.

This image shows the iRIS incomplete notification

 

This becomes a problem when one then tries to submit the Modification form back to the IRB, and it will block you from being able to do so.

 

To correct this issue, all that one needs to do is:

  1. Go back into the ‘Incomplete’ version of the DUHS IRB Application;
  2. Click on the final Application section, 4300 Application Complete Section (see below);
  3. Click on the Save and Continue to Next Section button;

This image shows the iRIS Application Complete section

 

4.  Then, when returned to the Modification Request form, the DUHS IRB Application should now no longer be noted as ‘Incomplete’ (see below).

This image shows the iRIS Application Submitted flag

You should now be able to save, and otherwise submit the form back to the IRB.

 

 

 

DOCR NEWS

 

Research Professionals Network:  Professional Portfolio Development – You Don’t Have to Hit Pause!

Thursday, May 7th, 1:00 PM -2:00 PM

 

Let’s talk about what has happened to our clinical research environment due to COVID-19 and how you can stay on track for professional development.  This session will focus on strategies for building a successful portfolio and a professional career in clinical research. In addition, this session will feature a Q&A session with RPLs, CRCs, Regulatory Coordinators, and CRNCs who have successfully achieved Tier Advancement. A key piece to their success was building a strong portfolio. Attendees will be able to seek advice from those who have built a successful portfolio. While Tier Advancement may be postponed until next year, it’s never too early to start planning for your future!

 

When: Thursday, May 7, 2020, 1:00 PM - 2:00 PM EST
Where: https://dukemed.webex.com/dukemed/j.php?MTID=m3f1f833d814d2f0b32aedf2d215a7908

 

Speakers:  Denise Snyder and Donna Crabtree

 

Learn more about the Research Professionals Network at docr.som.duke.edu

 

Society for Clinical Research Sites Free Membership Available to Duke Research Employees

The Society for Clinical Research Sites (SCRS) was founded in 2012 in response to the growing need for a global organization representative of the needs of clinical research sites. SCRS currently represents over 9,500 research sites in 47 countries. SCRS is an active partner in industry-wide initiatives and dialogues focused on improving the clinical research enterprise.

 

SCRS strives to build the clinical research community through four pillars:

  • Advocate
  • Educate
  • Mentor
  • Connect

 

Create your free membership today! 

 

Go to:  https://myscrs.org/

  • Select Member Login from the upper right hand corner
  • Use your duke.edu email address to join the SCRS community

 

 

RECRUITMENT INNOVATION CORNER

Recommendations and Best Practices to Support Remote Research Engagement, Recruitment and Retention

This is a graphic of the words Best Practice

Last year, Duke’s own Clinical Trials Transformation Initiative (CTTI) published recommendations to support the adoption of mobile technology in clinical trials, specifically focused on the need to engage sites and patients in planning trials that will use digital or mobile technology.

The COVID-19 public health emergency has certainly forced many of you into rapid adoption of the use of digital and mobile technologies in your studies!

A recent JAMA Viewpoint article recommends "…research staff should keep participants informed about the effects of the coronavirus pandemic on their trial participation... For many randomized trials, communication from research staff is likely to help protect against dropout or nonadherence by reassuring participants that their trial involvement remains important, even during the pandemic."

This is an image of a woman on her cell phone

 

CTTI has recently released Best Practices for Conducting Trials During the COVID-19 Pandemic, which include recommendations to ensure that participants are kept well-informed, stressing the “need for a plan, process and decision making” that includes:

  • Who will be responsible for informing participants
  • When and how they will be kept informed
  • Crucial information that participants will need such as changes to allow remote or home-based visits and any training or support they may need to accomplish remote visits or the collection of data
  • Consideration of the perspectives of participants, including their safety, risk tolerance, and personal priorities during the pandemic such as anxieties over illness, disease progression, finances, job stability, childcare needs, etc.

This is the image of a survey on a smart phone.

 

You have an opportunity to offer information, comfort and reassurance to your new and existing participants as you interact with them in novel ways. The more reassuring you are, the more likely they are to stay engaged and feel cherished for their participation.

 

 

We know much of your traditional recruitment activities are temporarily paused. However, the RIC can still help you develop engaging eConsents, MyChart messages, websites, engagement letters, research notices. We can also help you identify new strategies and tools to use when taking your research into the virtual realm.  Contact us for any of your research needs!

Additional resources: FDA guidance; CTTI COVID-19 Best Practices webinar

 

 

DID YOU KNOW?

REDCap:  Opting out of Emails and Text Messages

When setting up projects in REDCap that send emails or text messages, the participant should be given the option to opt out of receiving the emails or text messages.  There are number of ways to accomplish this in REDCap.  One way to do this is to include an opt out option at the end of a survey and logic would be built-in the Automatic Survey Invitation (ASI) that no longer triggers the message.

 

Join us during office hours with any questions.

 

 

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

 

Upcoming training offerings can be viewed by month on the DOCR Calendar.

 

Detailed information about each offering and direct links to the offering are also available on the DOCR website under Available DOCR Trainings.

 

 

PARTNER RESOURCES

DUHS Compliance Office

Catch up on news from the DUHS Compliance Office.

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