The normal day to day operations of all sectors have been affected by the outbreak of COVID-19, and it has made most non-essential employees resort to working from home. The medical industries have not been spared, and this has stalled a lot of clinical research. Clinical visits and schedules have also been cancelled due to this pandemic. However, clinical researchers can remain productive during this crisis through the following ways:
Engage in Training and Re-training
If it has been long since you reviewed the Code of Federal Regulations, this is the best opportunity to undertake some in-depth training. Your team should be trained on the fundamentals of good Clinical Practice to ensure that they are well equipped. The training can be done virtually under the FDA rules and regulations. Once the training on the basics is over, keep brushing on current protocols to improve your skills in handling your ongoing projects. Furthermore, start documenting what protocol requirements may be impacted during this moment. Finally, consider reviewing your study protocols for the upcoming projects to make your team active once normalcy returns.
Engage in Data Entry and Remote Monitoring
It would be best if you took advantage of this time to catch up on data entry and query resolutions for the earlier neglected projects. Besides, work on encrypted file-sharing technology to help you in facilitating remote monitoring visits. You may also assist your research sites with data entry and verification. Also, consider utilizing telehealth to monitor your subjects’ status in the electronic medical record for unreported events. Though your operations may change during this crisis, patients’ safety should always be given the first prominence.
Trial of Master File and Auditing
Clinical researchers are always the best when it comes to keeping records in an organized way. However, if you had piled documents waiting to be processed, ensure they are worked on and updated. Also, have an audit on your electronic naming conventions that are inconsistent and update your Trial Master File. Consider even requesting vendor audits on your Trial Master File to ensure your bioresearch monitoring is ready. Audits from an outside vendor will have an independent review and give you an accurate image of your clinical research study.
Standard Operating Procedures Review (“SOP”)
Your firm’s standard operating procedures are designed to provide the framework for a proper functioning and efficient workplace. Furthermore, when SOPs are well documented, they offer a good foundation for the execution of clinical trials. Well documented SOPs will also help your institution in prioritizing human subject protection. You should also refresh your understanding of the FDA requirements and have a good look again at your institution’s SOPs. Ask yourself if they have included appropriate provisions to promote a well-executed clinical study. If your SOPs are vague and outdated, accountability at your workplace will be inhibited. Therefore, your institution should have a standard and well laid standard operating procedure for accountability and productivity. There is no doubt that seasoned players in the biomedical field, such as DarioHealth Corp. (NASDAQ: DRIO) are taking full advantage of this lull in activity to fine-tune their backend operations.
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