Hello Research Nurses, wanted to see how COVID-19 was impacting your organizations, your participants, your processes. Chime in!
In Ireland the Health Products Regulatory Authority (HPRA), regulator for clinical trials, now has a dedicated webpage for management of clinicaltrials during COVID19: http://www.hpra.ie/homepage/medicines/regulatory-information/clinical-trials/covid-19-(coronavirus)-and-cts
I am not based in the UK but the advice from their clinical trials regulator (Medicines and Healthcare products Regulatory Agency) is available at https://mhrainspectorate.blog.gov.uk/2020/03/12/advice-for-management-of-clinical-trials-in-relation-to-coronavirus/
This is a useful link regarding COVID19
Published On March 13, 202
The University of Florida and UF Health, in an effort to enhance the safety of the local community, patients, and research teams, is temporarily closing access for in-person monitoring visits and scheduled meetings by clinical study sponsors. This closure will remain in effect until April 30, 2020 due to circumstances related to current and anticipated impacts of COVID-19. At that time this procedural change will be reassessed.
For new studies in which a study initiation visit (SIV) has been scheduled, we are requesting sponsors allow remote SIV (i.e. Zoom, Skype, WebEx etc) or postpone their visit.
Remote monitoring will be assessed on a case-by-case basis. Requests for remote monitor access can be made by study teams following the standard process. Sponsors will need to work directly with study teams during this closure to determine if remote access is appropriate for the nature of the required monitoring.
For federally funded projects, it is critical that we follow applicable regulations. Specific guidance for NIH is available and continues to evolve – See https://grants.nih.gov/grants/natural_disasters/corona-virus.htm. In some cases, it may be appropriate to coordinate with your award program and grant management staff. Questions should be directed to Stephanie Gray firstname.lastname@example.org at UF|Research Sponsored Programs.
Please provide this policy to your study sponsors as necessary. As new information becomes available regarding the COVID-19 response, this policy may be updated and/or the visitor restriction lifted.
Brian J. Sevier, Ph.D. | COO, Clinical and Translational Science Institute | Director, Office of Clinical Research | 2004 Mowry Road | PO Box 100219 | Gainesville, FL 32610-0219
Date: Friday, March 13, 2020
Subject: Essential Research Activity in the UF CTSI Clinical Research Center (CRC)
Dear CRC Investigators and study teams,
Thank you for your patience as we adjust the UF CTSI Clinical Research Center (CRC) operations to address the COVID-19 situation.
Per guidance from UF Health and UF Research leadership we are rolling back to essential research activity only, effective at close of business Friday, March 13, 2020 and until further notice. This is critical to ensuring the health of our research participants, staff, and faculty.
Beginning Monday, March 13, 2020: We will provide services for essential research activities according to the following guidelines:
· CRC will have reduced hours of operation: Tuesdays, Wednesdays, and Thursdays from 7:30 a.m. to 5:00 pm.
· We will evaluate requests for scheduling patient visits on a Monday or a Friday if critically necessary, on a case-by-case basis based on pre-scheduling requests.
· Scheduling research visits will be through WEBCamp – and all visits must be scheduled and approved in advance – no walk-in appointments.
· Only essential treatment–oriented study visits for currently enrolled participants only.
· No screening or enrollment activities or healthy control visits may be conducted in the CRC at this time.
· No staffing will be provided for after hours or nights.
· No moderate sedation or high acuity procedures may be conducted at this time.
Investigators: Please review your current scheduled CRC visits to determine which non-essential visits can be cancelled or postponed. Please confirm whether essential visits may need to be rescheduled to fit the operational schedule outlined above. For any essential visits that cannot be rescheduled contact us right away.
Important Contact Information:
For all questions or concerns – please send an email to CRC-ADMIN-L@lists.ufl.edu.
CRC Nurses Station (Tues, Wed, Thurs only): 352-294-5867
Janet King, CRC Manager: email@example.com; Voice Mail 352-294-5882
We look forward to continuing to serve study teams when we resume normal business operations. If you have any questions about COVID-19 please visit the University of Florida’s COVID-19 information page http://www.ufl.edu/health-updates/ and UF Health’s COVID-19 information page for updates https://ufhealth.org/2019-novel-coronavirus-covid-19
DATE: March 12, 2020
FROM: David P. Norton, Vice President for Research
UF|Research is committed to supporting the research community as our institution addresses COVID-19.
While the university is requiring that all classes be moved online, there are currently no restrictions or limitations on research activities. Access to research facilities remains unchanged for faculty, staff, graduate students and others who are engaged in these activities.
UF|Research will continue to provide existing research support services for proposal submission, award management, compliance, animal care, and other functions.
Sponsored research should continue, with the understanding that some activities may need to be modified or performed at alternate workplace locations at some point. For individuals paid through a grant or contract, the expense allocation should continue so long as the individual continues to work on the project, either from campus or elsewhere. If challenges related to COVID-19 prevent the execution of activities supported on a grant or contract, please contact Stephanie Gray (firstname.lastname@example.org) or Tiffany Schmidt (email@example.com) for guidance.
Researchers are encouraged to institute recommended practices that minimize potential exposure to COVID-19 within the research workspace environment. UF guidance and related links can be found at http://www.ufl.edu/health-updates/.
The Ohio State University and COVID-19 (Research guidance)
At OSU IRB posted COVID-19 guidance:
The OSU CCTS posted this:
And points to consider with links:
It will be interesting to track the responses, compare/contrast and see how things evolve.
One thing I've heard from a friend working in Pharma- the site visits are halting and going 100% to remote monitoring, which is actually the new standard that is evolving and accepted by FDA anyway.
Communication is everything. So each study should have a communication plan. Don't expect a bunch of protocol amendments about this- because each IRB is responding slightly differently. Analyze your protocols and for each come up with your COVID-19 plan - for that study- and circulate it to the sponsor and then IRB for approval to allow for planned, and approved deviations.
Here is something from WCG/WIRB
Contact The Supplier
WIRB-Copernicus IRB has received questions from several research sponsors about the appropriate process for making changes to clinical studies in response to the current COVID-19 epidemic. These changes may include things like:
We want to provide information on the requirement for IRB review of changes in research made in
response to this situation.
The FDA regulations require that:
Each IRB shall … (a) Follow written procedures for ensuring that changes in approved research, during the period for which IRB approval has already been given, may not be initiated without IRB review and approval except where necessary to eliminate apparent immediate hazards to the human subjects. 21 CFR 56.108(a)(4).
If a sponsor or investigator needs to make a change to research plans in order to eliminate apparent immediate hazards to research participants, these changes can be made and then reported to the WIRB-Copernicus IRB within 5 days, as per WCG policy. Eliminating immediate hazards may include actions to reduce potential exposure to COVID-19, or to continue to provide medically necessary study care (including study drug) to participants who have been placed in isolation or quarantine because of suspected or known exposures. WCG encourages sponsors and investigators to take such steps as necessary to eliminate apparent immediate additional risks to participants.
The notification to the IRB may be a full protocol amendment, but it does not have to be. The notification of the change in research (CIR) plans may also be a memo, letter, or other document that explains the changes being made, and provides enough information for the IRB to assess the relative risks resulting from the changes. The amendment or CIR document will proceed through IRB review as per the usual process.
If you have questions, please contact your WIRB-Copernicus IRB representative, or Client Services, and they will be able to connect you with a member of our regulatory, medical or compliance teams as needed.
About WCG (WIRB-Copernicus Group)
WCG is the world’s leading provider of solutions that measurably improve the quality and efficiency of clinical research. The industry’s first clinical services organization (CSO), WCG enables biopharmaceutical companies, CROs, and institutions to accelerate the delivery of new treatments and therapies to patients, while maintaining the highest standards of human subject protection. For more information, please visit www.wcgclinical.com or follow us on Twitter @WCGClinical or LinkedIn.
We have seen all non therapeutic research put on hold. Our oncology and other therapeutic trials continue, but there are new developments daily (or more). We have been having daily huddles with research teams and leadership. Communication during this time is very important. Because some of our patients do not have a visit scheduled with their provider, they are not getting the robo calls from the clinics, study teams are calling 2 days in advance of the visit to screen participants. I am amazed at all of the brilliant and dedicated people that surround me. Many "non essential" employees are working from home so finding new ways to communicate and care for our participant's is an ongoing adventure.
International Association for Clinical Research Nurses
2331 Rock Spring RoadForest Hill, MD 21050, USA443-640-1041 (Phone)443-640-1031 (Fax)firstname.lastname@example.org