Many clinical researchers are still doing their work behind closed doors. Despite being in the middle of the pandemic, they have tried to keep their trials or tests going remotely and they would want to open again fully. It is not the researchers alone who are eager for the research sites to open. Other stakeholders, including interns, have found themselves in that dilemma.
For instance, in the U.S., the three-phase plan for reopening the country indicates that researchers may return to work soon. As your research teams are preparing to return to their work stations, the safety of patients and staff must be a top priority. Clear policies for how your staff will be conducting their research activities once they are safe to return are needed. The following safety measures can allow the safe reopening of research sites:
Recommendations from the Centers for Disease Control and Prevention
Safe distancing in the workplace is one of the safety policies that have to be in place in the working areas. It will reduce contact between people at their work stations, hence making them safe. Safe distancing will be possible by doing the following:
- Employees should be working in shifts, thus limiting the number of people within the working site.
- The number of people congregating at the conference and break rooms should also reduce.
Changing the Design of the Sites to Allow for Safe Distancing During Monitoring Hours
Your research site should have a new design to minimize close contact during monitoring hours. For instance, you may consider doing the following:
- Setting up private working areas or conference rooms for monitor(s) away from your patients and staff.
- Resolving queries through web meetings and telephones even if you are close with the monitor.
- Wearing of masks by monitors when visiting the site.
Complete Your Site Initiation Visits
It would be best if you strived to think about how the study start-up activities will continue to progress. It will enable your sponsors to come in and help you finish the following activities quickly.
- Obtain the study documents and work with your staff to complete the forms.
- Conducting all pieces of training remotely (e.g., EDC, protocol, eTMF)
Ensuring Patients are Safe During Study Visits
Proper sanitation should always be in place within your site, and washing of hands with soap and water should be a norm within site. Some of these other protocols should also be in place:
- Rearranging of patients’ waiting rooms and common areas to ensure safe distancing
- Limit face-to-face contact by conducting follow up visits remotely
Changing the Schedule of Your Business
This is an era of “new normal”; hence things will be conducted differently. It would be best if you considered whether the research activities would be taking place remotely or onsite. The following should be considered:
- Can you gain access to the institution’s Electronic Medical Records and how challenging is the process?
- Are source documents accessible, and can they be securely shared through ShareFile or Box?
By following the measures mentioned above, the reopening of research sites will be possible, and the research will also be conducted efficiently. It would be interesting to hear what companies like Predictive Oncology (NASDAQ: POAI) are doing to resume full operations after the worst of the pandemic is behind us.
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