While many clinical researchers have been doing their best to keep trials moving forward remotely amid the coronavirus pandemic, everyone is eager for their sites to reopen.
In the United States, the announcement of the President’s three-phase plan for reopening the country indicates we may see some teams returning to work soon. This will happen slowly, based on the trajectory of the virus in each state and at the direction of public health experts and government officials.
In the rush to make up for lost time, your research teams might be tempted to return to work before they’re ready. When your research teams return to work and your sites reopen, the safety of your patients and your staff must remain your top priority. Once you have determined it’s safe to reopen your sites or offices, establish clear policies for how staff should conduct their research activities once they are permitted to return. Although we don’t have a specific timeline, there are some steps you can take now to prepare.
Follow these recommendations, based on guidelines from the Centers for Disease Control And Prevention.
The CDC has been recommending employers practice safe distancing in the workplace, including:
- Implementing flexible hours (such as having employees work in shifts)
- Allowing at least six feet between desks or workspaces
- Limiting the number of people who congregate in common areas, such as breakrooms or conference rooms
With the above in mind, what should you be thinking about in terms of your clinical research activities?
Making Changes To Sites To Allow For Safe Distancing During Monitoring Visits
Consider what adjustments you can make at your sites to minimize close contact during monitoring visits. For instance, you may need to:
- Set up private conference rooms or work areas for monitor(s), away from staff and patients
- Prepare study records and product in advance and designate a specific “drop off” area to avoid frequent exchanges between your staff and the monitor
- Resolve queries via telephone or web conference even when you are in close proximity to the monitor
- Require monitors to wear masks when visiting your site
Completing Site Initiation Visits
Think about how study start-up activities can continue to progress- once Sponsors can move forward, they will want to work with you to complete these activities quickly!
- Obtain study documents and work with your site staff to complete any necessary forms (e.g. agreements, Delegation of Authority Log, etc.) ahead of the site initiation visit
- Consider whether some/all training can be conducted remotely (e.g. protocol, EDC, eTMF)
- If on-site training is necessary (e.g. the investigational device requires hands-on training), determine if this can be done on a rotating basis for each investigator instead of a large group of research personnel being trained together at once
Ensuring Patient Safety During Study Visits
Make sure your sites are well-stocked with soap, hand sanitizer, and cleaning supplies. Employees should be instructed to wipe down and disinfect shared surfaces often. Continue to remind employees to practice frequent handwashing and discourage handshakes.
Brainstorming ways to manage informed consent and other protocol requirements requires flexibility and ingenuity. Consider the following:
- Rearrange patient waiting rooms and common areas to ensure safe distancing.
- When possible, conduct follow-up visits remotely and limit face-to-face contact with patients to only essential procedures.
- Determine if some study procedures can be completed via telephone, such as reviewing current medications, or via mail, such as completing subject questionnaires.
- Consider additional trainings and expanded delegations so fewer study staff need to interact with patients during an in-person study visit.
- Assess which data is crucial to obtain while also keeping in mind the risks associated with an on-site visit based on the individual patient
Getting Back to Business as Unusual
Many clinical researchers are accustomed to frequent travel and may be eager to return to it when it’s safe to do so. It’s important to keep in mind that when clinical research sponsors, investigators and site coordinators return to work, we will be returning to a “new normal.” You should continue to evaluate upcoming trips, such as monitoring visits and investigator meetings and make informed decisions in regards to exposing yourself and others to COVID-19. In some cases, remote monitoring or electronic trial master file audits may be the best option. When determining whether research activities can take place remotely vs. on-site, take into account the following:
- Are you able to provide/gain direct access into an institution’s Electronic Medical Records (EMR) system? If so, how challenging and time consuming is that process?
- Can source documents be accessed/provided via a secure file-sharing system, such as Box, ShareFile, etc.? Or does source need to be manually de-identified and sent to monitors for review?
- Does your study utilize an electronic Trial Master File (eTMF) where regulatory documents can be uploaded/viewed remotely? Do you need access to hard copies of documents to scan for the monitor/sponsor to review?
We have seen many ways that sites, sponsors, and monitors have collaborated to find creative solutions to the questions above to ensure some measure of continuity throughout this challenging time. The tremendous responsibilities sites and sponsors have to protect their employees while we all work together to protect patients in clinical trials has become even more evident now in light of the coronavirus pandemic.
The IMARC team takes this responsibility seriously. We can help you navigate this “new normal” by assisting with remote services, training your team, or helping you plan your next steps.
Contact us to learn more about how we can help.