Resuming Non-Essential Clinical Research Operations:

Guidance and Considerations:

As we prepare to resume non-essential clinical research operations, we need to move forward strategically and in a coordinated manner.  Investigators will need to develop plans to assure patient/subject safety, research personnel/staff safety, trial integrity, infection prevention measures, and responsible stewardship of PPE.  This document is intended as a guidance, and will serve as a framework to evaluate clinical circumstances, individual studies, priorities and resources in order to operationalize in a rapidly changing new normal. 
 
Information from TJU, State, Local and Federal authorities is evolving daily.  
•	Each department should utilize this guidance to determine the feasibility of resuming non-essential trials, as well as the prioritization of studies  
•	Resumption of clinical research should track closely with clinical operations and should be staggered to minimize the number of personnel on site, and in-person interactions 
•	 All research activities should remain remote, as much as possible   
•	Please include all key stakeholders and clinical areas when evaluating the questions in the guidance document and developing your plans  

This is an opportunity to capitalize on many of the recent innovative solutions, collaborate in new ways, and proactively address the uncertainties, as we plan for the continuation of clinical research.

Plans must include:

1.	The ability to follow the clinical practice guidelines, where the research will occur (clinic setting or hospital) to ensure:
a.	Patient/Subject safety 
b.	Research personnel/staff safety
c.	Patient flow 
d.	Infection prevention
2.	The ability to continue remote visits and processes as much as possible 
a.	Continuation of remote work for majority of staff
b.	Minimize the number of staff conducting in-person activities
c.	Minimize the time spent in-person with patients/subjects
3.	The prioritization and triage of protocols based on thorough analysis
a.	Staggered resumption of clinical research operations 

Timeline for Resuming Non-Essential Clinical Research Operations and Definitions:
Definitions:
Essential Trials, defined as:  “Essential to the participant’s wellbeing and or health”
•	High potential for direct benefit to research participants 
•	Currently ongoing

Moderate Potential for Direct Benefit (Non-Essential) Trials, defined as:  
•	Interventional and treatment trials (drug or device) 
•	Provide Moderate potential for direct benefit to research participants 
•	Current state: remote follow-up ongoing, and
•	Enrollment paused

Trials not critical to the health of the participant:  current risks to participants, research personnel and the TJU community does not meet the benefit
•	Entirely paused
•	Or, enrolling if all research procedures performed remotely

Timeline:
•	Current State:  
o	Enrollment in essential trials only, or if completely remote
o	Performance of essential visits 
•	Wave 1:  Target start date of June 5th, 2020
o	Resuming high priority Non-Essentials Trials
o	Maximize piggy-backing onto TJU clinical visits
o	Maximize hybrid* or fully remote research
o	Phasing in required study personnel on-site for limited times
•	Wave 2:  Evaluation on or about June 22nd, 2020
o	Continue to resume Non-Essentials Trials
o	Resuming Trials not critical to the health of the participant
o	Maximize piggy-backing onto TJU clinical visits
o	Maximize hybrid/remote research
o	Phasing in required study personnel on-site for limited times
•	Wave 3:  To be evaluated on an ongoing basis, on or about July 20th, 2020
o	Resuming all available clinical research and in-person activities at TJU and in community
o	Phasing in required study personnel on-site 
o	Continuation of hybrid/remote research if feasible

*Hybrid refers to maximizing remote processes and minimizing in-person contact to the greatest extent possible, before resorting to in-person research procedures.

Considerations:
Departmental Priorities:

Scientific Importance:
•	Is study medication essential to patient health? 
•	Do the diseases or conditions being studied take priority?
•	Do COVID-19 studies take priority over this disease areas?
Funding:
•	Internal Funding?
•	Grant/Sponsor funding?
•	Jefferson Investigator Initiated Multi-Site?
Priority according to Sponsor?

What’s the impact of closing the study?
•	How can subjects come off study safely?
•	Will there still be data monitoring requirements?
•	What is the scientific impact of not continuing this study? 

Current status of study:
•	IRB approved?
o	Study is closing/terminate
•	Open to enrollment (sponsor)?
o	Close to enrollment cap?
o	Enrollment extended?
•	Amendments necessary?
•	Do you still have the ability to recruit subjects?
o	Will recruitment strategy need to change? 
o	Are there factors influencing participants’ willingness to enroll or continue in the study?
Projected number of participants over time?
•	Currently enrolled subjects
•	New subject enrollment projections based on pre-COVID numbers [feasibility]
•	Where is the study in terms of overall enrollment?

Feasibility:

•	Can all procedures be performed remotely or virtually? 
•	Is a hybrid model, with goal of limiting in-person time/exposure possible?
o	Consent
•	Remote or eConsent in place?
o	Subject visits
•	Telehealth can replace in-person
•	No ancillary services or other departments needed
o	Data collection
•	Virtual?
o	EDC entry
•	Virtual?
o	Monitoring/Site visits
•	Remote monitoring agreement in place?
• What ancillary services would be needed? 
•	Investigational Pharmacy, Lab, Imagining, Nursing, Surgery, Infusion Services, Radiology
•	Are they willing?
•	Can they manage the time, space and services needed?
•	Can these services by provided off-site?
•	No ancillary services or other departments needed
• Research staff interactions with subjects and with other staff
•	Can procedures be performed with a limited number of staff, or one staff member?
•	How many in-person visits required?
•	How much time is required in-person for visits and can it be limited?
•	Where will visits occur? (clinic, research space, ancillary space [lab, radiology, PT])
•	How many ancillary staff will have exposure?
•	Is social distancing possible?   
•	Ability to room patient immediately? [Waiting in car until called into private room?]
•	Is a limited staffing model possible (shifts, extended hours)?
•	Will subjects be screened prior to visit and upon arrival to the visit?
o	Procedure in place?
•	Can screening be performed remotely?

• Considerations for staff and participant safety (PPE) 
•	Does your department have adequate PPE (masks, gloves, gowns, face shields, hand sanitizer)?
•	Is there Sponsor/financial support to cover additional costs or provide equipment?
•	If processing labs:  adequate equipment and infection control measures (hand washing station)?
•	Research area disinfected daily?
•	What training is required?  How will it be provided and documented?

Resources:

PPE:  Follow the process for ordering supplies in ASCENT.  For issues related to PPE/supplies, contacts are: 

Anthony Moscatelli
AVP of Supply Chain Logistics
Phone: 215-503-1133
Anthony.Moscatelli@jefferson.edu

Glenn Barnett 
Senior Distribution Manager
Phone: 215.503.0703
Fax: 215.923.7657
 Glenn.Barnett@Jefferson.edu

•	When making requests, include cost center charge code

*Information and instructions regarding safe use of PPE are located in myJeffHub COVID-19 Preparedness pages

•	The link below is for the video describing correct donning and doffing of PPE: https://jam8.sapjam.com/groups/V6DNNXT1ZN1xRM1VUUmsws/documents/qTwQ3R6QWeGB5B6E2nZibT/video_viewer

For information regarding handling potential SARS-CoV-2 samples (Laboratory Practices and Techniques), please see “The American Biological Safety Association Considerations for Handling Potential SARS-CoV-2 Samples”
•	Available in Confluence:  https://confluence.jefferson.edu/display/JCRI/Jefferson+COVID-19+Active+Clinical+Trials?preview=/78166921/84381631/Lab_ABSA2020_Covid-19-dr3%20(1).pdf
•	Available in myJeffHub Jefferson Enterprise Clinical Research Community:  COVID-19 Internal Resources

Resources:
COVID-19 Infection Prevention Guidelines for Ambulatory/Outpatient Sites (If not piggy-backing onto clinical visits)*
*This information is sourced directly from JEFFERSON MEDICAL GROUP COVID-19 AMBULATORY PRACTICE RAMP-UP REFERENCE GUIDE Phase 1, Last Updated: May 8, 2020 
This document is meant to provide generalized guidance for infection prevention in outpatient settings during the COVID-19 pandemic. We understand that all sites are different. For example, sites may not have a single point of entry where temperature screening and masking can be done upon arrival. Therefore, some of the recommendations may not be possible or applicable at every site. 
Patient’s Arrival at Building Point of Entrance (if staffing is available) 
 Patient will be called prior to their appointment and screening questions asked 
 Single point of monitored entry/screening (if available) 
•	Entry point greeter will wear a surgical mask and face shield 
•	We prefer that patients come alone to their appointment. If not, there should be a minimum number of caregivers accompanying the patient, preferably no more than 1 
•	Patient and caregiver(s) will wear their own mask upon entry or will be provided a surgical mask (Bandanas are not considered an appropriate mask) 
 Recommend maximum of 3 persons in an elevator Patient’s Arrival and Rooming at Practice Site Office 
 A face shield (and surgical mask) must be worn by all front-line staff members involved with intake and registration of patients 
 A face shield (and surgical mask) should be worn outpatient practice site clinical staff members 
 Patient and caregiver(s) will be provided a mask if not already masked (see above) 
 Screening questions will be asked to patient and visitor(s): 
•	Have you been diagnosed with COVID-19 in the last 21 days 
•	Have you been in close contact with a COVID-19 patient in the last 14 days 
•	Do you have any of the following: cough, shortness of breath, fever, headache, chills, sore throat, repeated shaking with chills, new loss of taste or smell, muscle pain 
NOTE: Patients with previous COVID-19 diagnosis are considered no longer infectious if it has been 21 days or more since their diagnosis and they have minimal or no symptoms 
 Temperature check, if desired by practice site (fever defined as >100.4o F) 
 All patients should be roomed as soon as possible 
 If patient/caregiver(s) screen positive (symptomatic), or are febrile, individual practice sites can decide to (options): 
•	Immediately room patient (and make sure they are wearing a surgical mask) 
o	Check-in should be completed in the exam room 
o	Medical staff should wear full PPE (gowns, gloves, N95 masks, and face shields) in these rooms 
o	Patient and caregiver(s) should remain masked during the entire visit (except during exam or treatment as indicated) 
•	Place patient in the waiting area, 6 feet apart from staff and other patients, awaiting exam room placement (if no other option is available)  
•	Reschedule patient visit 
•	Other (as preferred by the practice to include telehealth)
•If screen is negative (asymptomatic) for patient and caregiver(s), they should remain masked and can wait in the waiting room, appropriately distanced from staff and other patients
NOTE: Sites can refuse to see patients who refuse to wear masks, assuming they have been advised prior to the visit of our masking policy.
Completion of Patient Visit
• For patient and/or visitor(s) who screen positive (symptomatic) 
• Checkout should take place in the exam room 
• Patient and visitor(s) should leave with mask in place until they leave the practice site 
• For patient and visitor(s) who screened negative (asymptomatic) 
• Checkout can take place at the checkout area (or in the patient room, if desired) 
• Patient and visitor(s) should leave with mask in place until they leave the practice site 
Room Cleaning 
• The room cleaning procedure is the same for symptomatic and asymptomatic patients 
• For asymptomatic patients, surgical mask, face shield, and gloves are recommended 
• PPE for room cleaning for COVID-19 positive and/or symptomatic patients should include N95 mask, face shield, gloves, and gown (see table below) 
• After patient exits exam room or procedure area, please use hospital approved disinfectant to wipe all surfaces in room (paying special attention to high touch surfaces) 
• Let surfaces stay wet for recommended amount of time as indicated by the disinfectant 
• Sign should be visibly posted acknowledging room cleaning 
• All trash may be disposed into the regular trash unless items soiled with blood or body fluids 
• Ensure hand sanitizer is available and encourage patients use as exiting 
*For additional cleaning instructions, please refer to “Ambulatory/Outpatient Sites Cleaning (05/27/20)”
•	Available in Confluence:
•	Available in myJeffHub Jefferson Enterprise Clinical Research Community:  COVID-19 Internal Resources

Tips to Reduce Office Exposure 
• Eliminate or minimize use of office waiting room and crowding at check-in/out
 • Maximize physical distancing while in the office (6 feet apart) 
• Direct rooming from check-in/arrival 
• Alternate areas for seeing COVID+ and suspect patients, if possible 
• Suggested options (need to fit in with your practice needs): 
•	Spacing out in-person visits 
•	Mix in virtual visits with in-person visits or some sessions completely virtual 
•	Extended hours (7A-7P, Saturday hours) 

SOCIAL DISTANCING GUIDELINES (Capacity Management and Workflow Updates) 
These parameters will help ensure social distancing efforts are maintained to provide a safe environment for our patients and employees:
 All practices should implement direct rooming to the full extent possible in an effort to eliminate patients sitting in the waiting room. 
 All visits (office and telehealth) should be confirmed with patients manually by phone. 
•	Telehealth outreach should continue as it has over the past several weeks. 
•	Office visit confirmations should include scripting (sample scripts to follow) to notify patients of precautions we are taking, as well as promote MyChart functionality to complete registration and check-in virtually so less personal contact is needed once they arrive at the office. 
 Guests/Visitors should be eliminated to the extent possible. A notice should be included in automated and manual appointment reminders. Exceptions will need to be made for medical necessities.

STAFFING GUIDELINES
 Staffing levels should ramp-up in line with visit volumes. 
•	Many of the centralized functions supporting COVID-19 efforts at testing sites and in the hospitals will be needed indefinitely. Prior to pulling back staff that have been redeployed to support those areas, staff that have been using ETO should be brought back. 
•	Staffing requirements to support a changing mix of in-person and telehealth visits should be analyzed regularly, with adjustments made as needed. 
 Extended hours will need to be staffed without offering overtime. Overtime is not approved until further notice.

Worksheet to assist with evaluation and prioritization of individual studies:

Essential Trials:  “Essential to the participant’s wellbeing and or health”                                                       Moderate Potential for Direct Benefit (Non-Essential) Trials  
Trials not critical to the health of the participants
We have not identified any strategies to mitigate this. We might need new SOPs or other major changes in this area.

Legend:

Departmental Priorities

	

Scientific Importance:
				
Importance of funding:
				
Priority according to Sponsor:
				
What’s the impact of closing the study?
				
Current status of study:
				
Projected number of participants over time?

Feasibility:

	

Can all procedures be performed remotely or virtually? 				
Is a hybrid model, with goal of limiting in-person time/exposure possible?	 			
What ancillary services would be needed?
				
Research staff interactions with subjects and with other staff 
				
Considerations for staff and participant safety (PPE)