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Table 1 Recommendations for managing clinical trials during a pandemic

From: Managing clinical trials during COVID-19: experience from a clinical research facility

Leadership Priority setting within host institutions/clinical research facilities that research is an essential service and a necessary part of the solution to the public health crisis
Mobilisation of the team and organisation of flexible work schedules for the full team to maintain study flow, as well as facilitate staff who have childcare issues due to the closing of childminding facilities. Rotations and back-up staff schedules are also necessary to allow for the fact staff may need to self-isolate. Ensuring all staff are not on site together to minimise the possibility of contraction of the virus is critical.
Ongoing risk assessment due to the rapidly changing environment and public health advices.
Encouragement, motivation and energising staff through regular communication and providing social support.
Communication Communication strategy within the host institution/clinical research facilities to keep staff engaged.
Establishment of virtual meetings by Skype/Zoom/MS Teams study training sessions, and for sharing information and mitigating risk.
Daily conference calls should take place between the trial team, so the workload is distributed amongst all staff equally. Subject-specific issues can also be discussed during this time.
All emails should be cc’d with all nurses to ensure no data is lost in the event of staff becoming unwell.
Establishment of an online telephone group for the team, e.g. WhatsApp, which is critical for the social support of staff.
Establishment of virtual meetings by Skype/Zoom/MS Teams study for virtual coffee/social support (non-work related activities).
Maintaining contact with other research centres is important to troubleshoot as well as provide moral support in an evolving crisis.
An extra level of collaboration is required between the medical staff and the trial manager to facilitate conducting remote visits and safety assessments prior to IMP distribution.
Regular communication with trial monitors is essential.
Ethics Establishment of an expedited ethics approval locally is paramount as a change in protocol is required in order to ensure studies can proceed.
Email integrity is crucial at this time as there are a lot of emails going to participants and separately going to sponsors and this may inadvertently cause an error in sharing identifying information or sharing information with staff who should remain blinded.
Technological supports Establishment of remote access for many systems, e.g. establishment of remote access to the hospital laboratory system and also ITU to monitor COVID-19 patients remotely.
Access to a secure shared drive to store trial documents so they can be accessed remotely and securely as most work is done from home.
Remote access for CRF Manager room booking so that staff can work in the hospital and keep a safe distance from each other.
Online GCP programme is necessary.
There may be difficulty printing emails due to restrictions of office space. A study folder should be created, and all documents stored there until access to a printer is available.
Engagement with regulatory authorities Supplying ongoing IMP to participants is vital. This will need to be carefully considered to maintain the blinding of the sponsor, i.e. not providing names and addresses, to maintain research integrity, and to ensure safety of both staff and participant at all times.
Receipt of IMP should be verified by staff via phone call to the participant, or the participant’s parents if a minor.
Shipments should be clustered so as to limit staff time in the hospital and thus protect their safety. Deliveries should be limited to specified days also.
Participant engagement Contact with participants to ensure retention is critical.
A study phone should be carried by one member of the team to cover 24/7 contact from trial participants. This should be shared amongst the trial team, i.e. trial managers, research nurses, PIs and co-PIs.