Dean’s Office and PPHS

Guidance and Recommendations for Onsite and Remote Monitoring (9/15/2020)

Guidance and Recommendations for Onsite and Remote Monitoring 

The last update from the Dean’s Office (7/30/2020) regarding study monitoring advised that monitoring activities that can be virtual/remote should remain virtual/remote until further notice, with only limited exceptions for onsite monitoring.  As the situation persists, the ORS has worked with the Department of Medicine,Clinical Trials Office (MCTO) to produce on guidance and recommendations for remote monitoring activities.  The guidance and recommendations may  evolve and we will continue to update the research community.

It can be found on the Research Road Map: Monitoring and Audits. There you will find a link to the SharePoint environment available to MSHS employees to access the documents.

Remote Access to EPIC for Monitors

As part of the guidance we describe how Mount Sinai provides restricted access to the electronic medical record, EPIC.  EPIC is certified by the Office of the National Coordinator for Health Information Technology (ONC).  The Monitor/Auditor is granted access only to trial subjects’ records and it is restricted based on date ranges / encounter numbers for research visits.  There is an unique password, read-only access to the EMR system assigned to the Monitor.  Monitoring is restricted to 3-5 days and access to records is revoked thereafter. An audit trail is available in EPIC.

We have made resources for remote monitor access available via Research Roadmap.  There are step-by-step instructions on “How To Request EPIC Access For Remote Monitors” this is for the research team and not to be shared externally of Mount Sinai. They are also located in the SharePoint environment accessible only to MSHS employees.  An SOP, Research 001: Remote Access to Epic for Monitors is available to be provided with the Monitor/Auditor to set-up an account, along with guidance for workflow once they have been provisioned an account. Mount Sinai Health Information Management (HIM) Policy for external collaborators to access EPIC remotely has been updated for external collaborators to access EPIC remotely including a confidentiality form (appendix 6) which must be completed by the monitor / auditor. This policy can be provided in addition to the SOP if requested by the Sponsor.

We encourage you to visit the Research Roadmap Monitoring and Audits and Research Roadmap information and the link to SharePoint environment. If you still need help, there are contacts listed within the documents in SharePoint to help answer questions.

Prior Approval Required for all COVID-19 Protocols (08/28/2020)

FROM:

Scott L. Friedman, M.D.
Dean for Therapeutic Discovery
Fishberg Professor of Medicine
Professor of Pharmacologic Sciences
Chief, Division of Liver Diseases

Rosalind J. Wright, MD MPH
Dean for Translational Biomedical Sciences
Icahn School of Medicine at Mount Sinai

DATE: August 28, 2020

RE: Prior Approval Required for all COVID-19 Protocols

This is an important reminder that all COVID-19 related studies must be submitted for review by the COVID-19 Protocol Committee prior to registering or signing agreements (contracts, collaborations, etc.), to conduct a clinical trial.

The streamlined process for submitting COVID-19 protocols for review is found here:  http://researchroadmap.mssm.edu/reference/covid-19-protocol-review-process-for-clinical-research/

Centralized review by the COVID-19 Protocol Review Committee ensures that the protocol’s scientific aims align with our overall institutional goals, there are adequate resources to support the trial and that there will be internal oversight of the conduct of the trial.

Thank you for your cooperation. If you have any questions please contact Research411.

Updated guidelines for on-site monitoring for clinical trials (7/30/2020)

TO:      All Faculty, Staff, and Students

FROM:

Dennis S. Charney, MD
Anne and Joel Ehrenkranz Dean
Icahn School of Medicine at Mount Sinai

Rosalind J. Wright, MD MPH
Dean for Translational Biomedical Sciences
Icahn School of Medicine at Mount Sinai

Glenn Martin, MD
Senior Associate Dean for Human Subjects Research
Icahn School of Medicine at Mount Sinai

DATE: July 30, 2020

RE:      Updated guidelines for on-site monitoring for clinical trials

We commend the research community for your patience with our reopening strategy and, in particular, your adherence to the guidelines set forth to ensure a successful reopening of clinical research studies across the health system thus far.  Building upon that success, we want to update the research community regarding on-site monitoring for clinical trials.  As of Monday August 3, 2020, we will be relaxing the restrictions as outlined below.

Importantly, this is not a return to pre-COVID normality and success will once again depend upon our research community adhering to the following guidance. As this remains a fluid situation, please understand this guidance does not replace whatever more restrictive policies that may evolve for the Mount Sinai Health System, for example restrictions on travel related to COVID hot spots.

Guiding Principles for On-site Monitors

  • All monitoring activities that can be virtual/remote should remain virtual/remote; for guidance on the  institutional workflow developed to facilitate remote monitoring, contact Catherine Sinfield at Catherine.sinfield@icahn.mssm.edu.
  • Need to minimize both duration and number of episodes for on-site monitoring visits.
  • Individuals traveling from the New York/New Jersey/Connecticut/Pennsylvania and other states that are not NYS designated hotspots are allowed to do on-site monitoring visits. However, greater consideration should be given to those states at some distance from NYC as this requires travel that may have greater exposure risk (e.g., air travel).
  • Individuals from states listed as hot spots on the New York State travel advisory list will not be allowed to conduct on-site monitoring (https://coronavirus.health.ny.gov/covid-19-travel-advisory).

Implementation

  • Ensure monitors are aware of required safety measures
    • It is the responsibility of the research team to reach out to monitors within 24 hours of scheduled campus visit to conduct pre-visit screening for COVID-related symptoms and reiterate visitor policy.
    • All should be made aware of the risks involved with traveling to campus and steps to mitigate risks by masking, social distancing, practicing hand hygiene, avoiding crowds or modes of travel that increase potential exposure (e.g., subway, etc).
    • All hospital, departmental and clinic rules regarding COVID-19 prevention must be adhered to when monitors are on campus, including but not limited to screening and temperature checks upon arrival, Health System’s Visitor Policy, etc.
    • Plan visits/procedures to allow physical separation of monitors from other employees in all areas including work areas, meeting/break rooms, etc. to maintain social distancing guidelines (>6 feet).
    • Monitors must comply with masking guidelines https://www.mountsinai.org/files/MSHealth/Assets/HS/About/Coronavirus/MSHS_ProperUseFaceCovering-June24-2020.pdf using proper face coverings over the nose and mouth.
    • Frequent hand washing with soap and water or alcohol-based hand sanitizer.
    • Provide disinfecting wipes/cleaning materials for routine cleaning of frequently touched surfaces such as workstations, keyboards, phones, microwaves, printers, doorknobs, etc. in space designated for completion of monitoring activities.

If you have any further questions, comments or suggestions please contact the IRB at IRB@mssm.edu or Lori.Jennex@mssm.edu.  You can also reach out to Rosalind Wright, MD MPH at rosalind.wright@msssm.edu.

Continued opening of on-site human subjects research (06/30/2020)

TO:  All Faculty, Staff, and Students

FROM:

Dennis S. Charney, MD
Anne and Joel Ehrenkranz Dean
Icahn School of Medicine at Mount Sinai

Rosalind J. Wright, MD MPH
Dean for Translational Biomedical Sciences
Icahn School of Medicine at Mount Sinai

Glenn Martin, MD
Senior Associate Dean for Human Subjects Research
Icahn School of Medicine at Mount Sinai

DATE: June 30, 2020

RE: Continued opening of on-site human subjects research

Starting May 18th, we initiated Phase 1 for restarting essential face-to-face research visits for projects that have a possibility of direct benefit to participants (e.g., clinical trials). As of June 8th, Phase II marked the resumption of face-to-face visits including research not holding out immediate direct benefit to subjects (e.g., observational studies). We commend the research community for adherence to the guidelines set forth to ensure a successful reopening thus far.  Building upon that success, we will expand resumption of all face-to-face research in Phase III which will begin July 1st with few restrictions noted below.  Thus far, return of staff on-site has been on a voluntary basis in coordination with investigators. As we expand research re-opening in Phase III, staff engaged in activities necessitating them to be on site will be required to come in beginning July 13th which allows time for planning per guidelines laid out below.

We want to underscore that the COVID pandemic is far from over and restrictions on travel and our work environment may be reinstituted in the coming months. Researchers should prepare for that eventuality, even as they reopen more widely during this hard fought lull in the metropolitan area.

It is the intention of the ISMMS to expand clinical research activities in a manner that protects all subjects, staff, and maintains clinical care operations. Importantly, this is not a return to pre-COVID normality and success will again depend upon our research community adhering to the following guidance. As this is still a fluid situation, please understand this guidance does not replace whatever more restrictive policies may currently be in place within the Mount Sinai Health System.

Phase III Guiding Principles

As research staff return on-site, we must follow procedures to maintain social distancing

  • Plan staffing to allow physical separation of employees in all areas including work areas, meeting/break rooms, etc. to maintain social distancing guidelines (>6 feet)
  • Stagger work hours, lunch breaks, etc; encourage outdoor seating areas for lunch breaks
  • All meetings should remain virtual
  • Encourage safety measures to protect staff
    • Comply with masking guidelines (https://www.mountsinai.org/files/MSHealth/Assets/HS/About/Coronavirus/MSHS_ProperUseFaceCovering-June24-2020.pdf); use proper face coverings over your nose and mouth
    • Frequent hand washing with soap and water or alcohol-based hand sanitizer
    • Provide disinfecting wipes/cleaning materials for routine cleaning of frequently touched surfaces such as workstations, keyboards, phones, microwaves, printers, doorknobs, etc.
    • Employees who have symptoms of COVID-19 or who have sick family members should notify their supervisor, and others as required, e.g. Employee or Student Health Service, clinical department, etc., for guidance on staying home and clearance to return to work.
    • Employees who appear to have symptoms upon arrival or who become sick during the day should immediately be separated from others and sent home with instructions to follow up with Employee Health or Student Health.
  • All subjects coming on campus or to a Sinai office site must follow current COVID protections
    • The research team will contact subjects within 24 hours of visit(s) to conduct pre-visit screening for COVID-related symptoms and reiterate the visitor policy.
    • All hospital/departmental/clinic rules regarding COVID-19 prevention must be adhered to once research subjects arrive on-site, including but not limited to pre-visit screening at an established ambulatory practice area, wearing masks, Visitor Policy, lab testing, etc.
  • All subjects should be made aware of the risks involved with traveling to the medical center and being seen face-to-face. We encourage implementation of services to minimize risk related to travel, e.g., arranging Uber/Lyft rides, car services, etc. should be considered if possible; negotiation for support for such by sponsors/funders should be pursued
  • Continued efforts should be made to minimize face-to-face exposure, both duration and number of episodes. Activities that have been/can be done remotely should continue to be done remotely (e.g., all or part of the informed consent process, completion of questionnaires, etc. Activities tied to clinical visits should also be adopted to minimize time and disruption to clinic operations.
  • Subjects at increased risk for COVID-19, e.g. age, obesity, diabetes, heart disease, etc. should be identified and research procedures should be modified or postponed to minimize risks.
  • Scheduling must be tightly coordinated to location and should reflect added time to avoid crowding in waiting areas, clean rooms, get through screening, etc.
  • Visits must be scheduled to minimize waiting/crowding to maintain social distancing and minimize the impact on clinical activities. These should be coordinated at the local level.
  • Recruitment activities taking place in clinic waiting areas/clinic office space can be resumed if activities are consistent with current hospital rules, do not lead to increased crowding or unacceptable delays, and have the permission of the clinic.
  • Sample collection and processing should follow institutional rules, including modifications currently in place for SARS-CoV-2.

Implementation:

  • All projects need to obtain local and departmental approval before resuming face-to-face visits.
  • All projects are covered by this guidance, irrespective of the IRB of record.
  • Pre-Procedure COVID Testing for Research Procedures The CRU is available for pre-procedure COVID testing – nasal swab by appointment. Contact Joane Zephir, Joanne.Zephir@mssm.edu, for application and fee information.
  • Contact Beverly Cooper of MSH Clinical Labs at Beverly.Cooper@mountsinai.org or (347 931-4417 to set up/update your research account to facilitate pre-procedure COVID testing.
  • Please note that only pre-procedure testing is available for studies.  If you have a symptomatic subject, you should refer them to their primary care physician for further care.

Continued Restrictions

  • Procedures that may increase the risk of contagion spread, especially those that generate aerosols or require close prolonged contact remain restricted for on-site visits (e.g., spirometry, sputum induction). Please contact the PPHS to discuss restarting these once a plan has been developed that has local approval, and other necessary input, e.g., infection prevention.
  • On-site monitoring is still not allowed.  Notification will go out when the situation changes.  For guidance on the  institutional  workflow developed to facilitate remote monitoring, contact Catherine Sinfield at Catherine.sinfield@icahn.mssm.edu.

If you have any further questions, comments or suggestions please contact the IRB at IRB@mssm.edu or Lori.Jennex@mssm.edu.  You can also reach out to Rosalind Wright, MD MPH at rosalind.wright@msssm.edu.

Ramping up on-site not for benefit clinical research (06/02/2020)

The New York metropolitan region has made great strides in managing the COVID pandemic, to the point where the city should begin reopening from June 8th.  Starting May 18th, we initiated Phase 1 for restarting essential face-to-face research visits for projects that have a possibility of direct benefit to participants. We commend the research community for your adherence to the guidelines set forth for that first step to ensure a successful reopening thus far.  Building upon that and with the upcoming New York State and New York City relaxation in restrictions, in Phase II which will begin June 8th, we will also begin allowing the resumption of face-to-face research that does not hold out the prospect of direct benefit to participants.

It is the intention of the ISMMS to expand clinical research activities in a safe manner that does not needlessly endanger subjects, staff, or clinical care at the hospitals and clinics. There is a fundamental principle in research oversight that requires research to be conducted in a manner that minimizes risks to subjects, consistent with sound research design. Importantly, this is not a return to pre-COVID normality and our success will again depend upon our research community adhering to the following guidance.

To that end:

  • All subjects coming on campus or a Sinai office site must follow current COVID protections concerning pre-visit screening, temperature checks, wearing masks, etc.
    • It is the responsibility of the research team to reach out to participants within 24 hours of scheduled face to face visit(s) to conduct pre-visit screening for COVID-related symptoms and reiterating visitor policy.
    • All hospital, departmental and clinic rules regarding COVID-19 prevention must be adhered to once research subjects arrive on campus, including but not limited to pre-visit screening at an established ambulatory practice area, the Health System’s Visitor Policy, lab testing, etc.
  • All subjects should be made aware of the risks involved with traveling to the medical center and being seen face-to-face.
  • Efforts should be made to minimize the face-to-face exposure, both the duration and number of episodes. This means that activities that can be done remotely should be done remotely. This may include all or part of the informed consent process, completion of questionnaires, and rating scales etc. Activities that are tied to clinical visits should also be adopted to minimize time and disruption to clinic operations.
  • Subjects that are at increased risk of COVID morbidities, e.g. age, obesity, diabetes, heart disease, etc. should be identified and the research procedures should be modified or postponed to minimize risks.
  • Scheduling has to be tightly coordinated to location and should reflect added time to clean rooms, get through screening, etc.
  • All research visits must be scheduled in such as a way as to minimize waiting and crowding in order to maintain social distancing and minimize the impact on clinical activities if that applies. These should be coordinated at the local level.
  •  All recruitment activities taking place in clinic waiting areas or clinic office space are considered suspended. Activities may be allowed only with approval of the PPHS and will require appropriate assurances that the activities are consistent with current hospital rules and have the permission of the clinic.
  • Procedures that generate aerosols are not approved at this time (e.g., spirometry, sputum induction).

Implementation:

  • All projects need to obtain departmental approval before resuming face-to-face visits with subjects.
  • All projects planning to reinitiate face to face encounters must complete a short online form found here: PPHS Not-for-Benefit Research Ramp up Form
  • As the form will make clear, if you can attest to departmental approval, that the basic steps outlined in the above guidance have been taken to minimize risks, and that higher risk subjects are not involved in the research, then increased on-site activities may begin upon completion of the form.
  • As the form will make clear, for other projects where special precautions have to be considered to protect subjects at increased risk for complicated and fatal COVID outcomes, more formal patient notification will be required and a specific mitigation strategy has to be reviewed by the PPHS. You MAY NOT begin on-site activities until receiving notification from the PPHS. The PPHS will endeavor to review these within 2 working days of submission.

If you have any further questions, comments or suggestions please contact the IRB at IRB@mssm.edu or Lori.Jennex@mssm.edu. You can also reach out to Rosalind Wright, MD MPH at rosalind.wright@msssm.edu.

PPHS Not-for-Benefit Research Ramp up Form (06/2020)

Clinical trial ramp-up beginning May18th (UPDATE #1) (05/15/2020)

The purpose of this update is to explain the process for resuming onsite clinical research activities with the Mount Sinai Health System consistent with the May 13th Town Hall and the May 14th memo. This pertains to potentially “for-benefit” studies only, as they are the only face-to-face projects eligible at this time.  As detailed in our earlier notice, departmental review and approval is required for all projects. That process will be handled at the departmental level.

As detailed previously:

  • Special protections have to be considered for those studies that involve subjects at increased risk for complicated and fatal COVID outcomes. PPHS polices and Federal regulations mandate that investigators minimize risks to subjects consistent with sound research design. Telemedicine, remote monitoring, home infusions should still be utilized in most situations to minimize risks.BEFORE on-site activities resume, the PPHS must receive the plan for these subjects. This plan has to include a risk: benefit analysis and may also require an information sheet for PPHS review that will be shared with research participants.

Implementation:

All projects need to obtain departmental approval before resuming face-face visits with subjects.

All projects must complete a short online form found here: PPHS Phase I Clinical Ramp Up Form

As the form will make clear, if you can attest to departmental approval and that higher risk subjects are not involved in the research, then increased on-site activities may begin upon completion of the form.

As the form will make clear, for other projects where special precautions have to be considered to protect subjects at increased risk for complicated and fatal COVID outcomes, some form of patient notification will be required. You MAY NOT begin on-site activities until receiving notification from the PPHS. The PPHS will endeavor to review these within 2 working days of submission.

If you have any further questions, comments or suggestions please contact the IRB at IRB@mssm.edu or Lori.Jennex@mssm.edu

Ramping up on-site clinical research (05/14/2020)

TO:        All Faculty, Staff, and Trainees

FROM:  Dennis S. Charney, MD
Anne and Joel Ehrenkranz Dean
Icahn School of Medicine at Mount Sinai

Rosalind J. Wright, MD
Dean for Translational Biomedical Sciences
Icahn School of Medicine at Mount Sinai

Glenn Martin, MD
Senior Associate Dean for Human Subjects Research
Icahn School of Medicine at Mount Sinai

DATE:    May 14, 2020

RE:         Ramping up on-site clinical research.

It is the intention of the ISMMS to expand clinical research activities in a safe manner that does not needlessly endanger subjects, staff, or clinical care at the hospitals and clinics. As mentioned at the Research Town Hall held earlier this week, activities will begin to ramp up beginning Monday May 18th. As underscored in the Town Hall, this is a phased restart and for the initial weeks the following will govern. This policy impacts research at all Mount Sinai Health System sites that is approved by the ISMMS Program for the Protection of Human Subjects (PPHS)) as well as external IRBs.

ALL projects eligible to ramp up will need local and departmental approval before any changes can begin. Departments will need to coordinate and track these approvals. The PPHS will work with departments so we will not need to receive approval confirmation from each individual project. Certain projects will need to file a form with PPHS and await review and approval. Details will be provided in a separate communication that will distributed before the close of business Friday May 15th.

For-benefit interventional trials that require face to face contacts are eligible to use on-campus resources. During this initial phase, which overlaps with the increase in clinical activities including ambulatory practices, departmental approval will be necessary so that resources, including waiting area space, line length, ability to navigate to ancillary departments, etc. are properly allocated. The expectation is that the most clinically impactful projects will be prioritized. The PPHS will reach out directly to the departments to coordinate. In addition:

  • All hospital, departmental and ambulatory practice  rules regarding COVID-19 prevention must be adhered to, including but not limited to pre-visit screening at an established ambulatory practice area, the Health System’s Visitor Policy, lab testing, etc. Guidelines for Return to Practice.
  • All recruitment activities taking place in ambulatory waiting areas or office space are considered suspended. Recruitment activities may be allowed only with approval of the PPHS, and will require appropriate assurances that the activities are consistent with current hospital rules and have the permission of the clinic.
  • All clinical visits must be scheduled in such a way as to minimize waiting and crowding in order to maintain social distancing and minimize the impact on clinical activities. These should be coordinated at the local level.
  • Special protections have to be considered for those studies that involve subjects at increased risk for complicated and fatal COVID outcomes. PPHS polices and federal regulations mandate that investigators minimize risks to subjects consistent with sound research design. Telemedicine, remote monitoring, home infusions should still be utilized in most situations to minimize risks.  BEFORE on-site activities resume the PPHS must receive the plan for these subjects. This plan has to include a risk: benefit analysis and may also require an information sheet for PPHS review that will be shared with research participants.
  • For all studies, even those with subjects at no known increased risk of COVID, the use of Telemedicine, remote monitoring, home infusions, etc.  should still be utilized in many situations to minimize risks.

Biospecimen and registry trials:

  • To the extent that activities take place at a clinical visit they should not occur unless there is minimal burden to clinical operations and infection control. For example, consenting should begin, and possibly be completed, before arrival. To minimize time spent in the clinic setting, questionnaires should be completed off-site.  Subjects should not be coming to the hospital/clinic outside of a clinical visit.
  • All sample processing should follow institutional rules, including any SARS-CoV-2 modifications currently in place.

Other Not for Benefit projects are not included in this phase and are not authorized to use on-campus resources. Approved remote activities can continue.

External Monitoring Visits

On-site external monitoring visits continue to be suspended.

Protocol Review Process - Required for Interventional & Non-Interventional Studies

We have developed a streamlined process for reviewing COVID-19 protocols that our Mount Sinai investigators are developing as Investigator-initiated trials (IITs) or through collaborations with sponsors or other institutions. A centralized review by the COVID-19 Protocol Review Committee will serve as a mechanism for ensuring that the protocol’s scientific aims align with our overall institutional goals, there are adequate resources to support the trial and that there will be internal oversight of the conduct of the trial.

Learn More

General Considerations for Pre-IND Meeting Requests for COVID-19 Related Drugs and Biological Products (05/14/2020)

COVID-19 Public Health Emergency:

General Considerations for Pre-IND  Meeting Requests for COVID-19 Related Drugs and Biological Products

This guidance is being issued to address the Coronavirus Disease 2019 (COVID-19) public health emergency. This guidance is being implemented without prior public comment because the Food and Drug Administration (FDA or Agency) has determined that prior public participation for this guidance is not feasible or appropriate (see section 701(h)(1)(C) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 371(h)(1)(C)) and 21 CFR 10.115(g)(2)). This guidance document is being implemented immediately, but it remains subject to comment in accordance with the Agency’s good guidance practices.

COVID-19 General Considerations for Pre-IND Meeting Requests

Dean’s Office Phase I FAQ – Clinical Research

Office of Research Services (ORS)

ClinicalTrials.gov Guidance

ClinicalTrials.gov has not changed their requirements and if they do, ORS will notify research teams.

If your study has been put on hold due to COVID-19 please contact the ORS via our ticket system and indicated if your study is suspended (study expected to resume in the future) or terminated (study terminated early). If your study is terminated, please also provide the date (month, day, year) of the last study visit or the last date that data was collected, AND the total enrollment number.

Department Specific Guidance