TO ALL PRCTRC INVESTIGATORS AND COORDINATORS:
Following the institutional and government directives for a gradual increase of activities while ensuring the safety of participants, investigators and personnel, we now move to Phase 4 of the PRCTRC Protection & Prevention Plan for the COVID-19 Emergency. In addition to the protection measures implemented during phase 3 of our plan, this phase includes the following changes:
Beginning June 2nd:
We will increase the number of rooms in use, the number of studies, and the number of participants that we will serve.
Within the same clinical area in the PRCTRC that we provide for on-site visits and evaluations, a total of five treatment rooms will be available for daily use. Following an hourly schedule of visits, this will allow us to support 5 to 10 studies per day, depending on the needs of each study and the length of each participant’s visit and/or number of interventions. To continue complying with the physical distancing rules, we will distribute the personnel and spaces in the following way:
- 5 Investigators – one per treatment room
- 5 Participants – one per treatment room (at one time)
- 2 PRCTRC research nurses – at the vital signs room, the phlebotomy room, the counter, or the supervisor’s office.
- 4 Study Coordinators – specific areas will be assigned for the coordinators that need to be present during the subjects’ visit period. This will ensure that everybody will be in a specific area and avoid having people in the common areas or hallways. No personal items should be left at the assigned space since these will be rotated from day-to-day.
This arrangement will represent having a maximum of 16 persons in the clinical area at the same time. To avoid agglomeration in this area, it is very important that each person remains in the assigned room or area.
Investigators may use their assigned time slots to conduct follow-up visits or recruitment visits for new participants.
Phase 3 stated: “At any one time, only one to two research staff members (investigator and one coordinator/research assistant) will be allowed per clinic”. For Phase 4, since many of our active studies need the collaboration of a multi-disciplinary group, this rule will no longer apply.
- To maintain our measures to protect investigators and study subjects from potential exposure or contagion, the PRCTRC staff members will continue with the process of disinfecting the common areas and rooms upon arrival (7:00-7:30 am), prior to any investigators or participants using the areas. To have enough time to prepare the facilities for you, we ask that your earliest arrival at the Center is after 7:20-7:30 am. Likewise, we ask you to set your first participant to arrive at 8:00 am; this way, you will have time to prepare your working area, records, and dress-up with PPE.
- Monitoring visits by personnel from outside Puerto Rico will continue on hold. Monitors that are locally based can visit the PRCTRC facilities from 8:00 am to 1:00 pm, by prior arrangement with the administration.
- Several PRCTRC support cores are providing support using remote strategies. Investigators can contact the Biostatistics and Epidemiology Core, Regulatory Knowledge and Support, and Pilot Project Program PRCTRC Staff by email to request their support.
- At present, the PRCTRC does not have personnel for support in the Dental area to ensure appropriate protection for investigators or participants. Dental procedures will continue on hold.