Introduction

The rapid spread of unexpected COVID-19 since early 2020 has had a huge impact on all human being's life and has been disruptive to a wide range of industries. It is no exception to the clinical study industry. The impact is so profound that it is felt in many processes of the work, such as subject enrollment, subject follow-up, investigational drug shipment, data collection and data cleaning, etc. So how do we code with the pandemic and deliver our work smoothly? This article discusses briefly how CRA can better manage a site under the normalization of pandemic situation from 3 aspects, including scientificity, efficiency and speed.

Scientificity

Clinical trials are scientific and rigorous research activities that must comply with relevant laws and regulations. To do a good job in clinical trials, many "bottom lines" shall not be broken, especially under the normalization of pandemic situation, such as taking photos of subjects' medical records and disseminating them without the approval of the study site; or disseminating them after having gained the approval of the study site but without relevant documents being desensitized. CRA serves as a key supervisor of trial progress and quality in a study site. It's even more challenging for him/her to manage remotely under the normalization of pandemic situation. In the face of this situation and in line with the scientific and compliance requirements, CRA can provide remote and timely communication, online training and operational guidance on the operation of the process and the problems that arise in the site, such as the investigator's timely collection of medical conditions of the enrolled subjects, consultation with the project team, consultation with the medical team and review of relevant literature, and remote communication and guidance within the scope of scientific operation; for daily file submission, data entry, questioning and answering and SAE reporting, CRA can sort out and summarize problems in a timely manner and remind CRC or the investigator to solve them.

Efficiency

The clinical study industry has undergone a radical change in efficiency in nearly 7 years since the "722 event". Today's clinical trial operations have been rapidly upgraded from traditional research methods. Various high-tech equipment, digital systems and management software have been successively applied to all aspects of clinical trials. The 21st century has seen rapid changes in science and technology, and the clinical research industry has gradually entered into a digital era. eMonitoring and other digital intelligence software, the remote monitoring system we currently use on our platform, is more efficient than traditional paper cases, test report forms, or desensitized documents sent via mail. CRA can seamlessly access the center's clinical trial data center CDR/RDR by the remote monitoring system, perform remote monitoring and data cleanup, and keep up with the site's situation. Advanced digital system helps sponsors complete clinical trial studies more quickly and efficiently, thus shortening the time for new drug registration and marketing.

Speed

Under the normalization of pandemic situation, where site investigators cannot get to work in time, subjects cannot come to the hospital for follow-up, and neither CRC nor CRA can enter the hospital freely, it is the most urgent to find a quick and perfect follow-up method to ensure the rights and interests of the subjects. Subject follow-up is not available, investigational drug shipment and distribution are obstructed, and some clinical trial data collection is missing. Based on company-level business continuity plans or clinical study guidelines during the COVID-19 pandemic, CRA may communicate and discuss solutions remotely with investigators, ethics committee, institution, medical team, and project team, and discussion resolution can be submitted either remotely or on-site by the investigator to the institution and/or ethics committee for the record, including subject transfer to the study site, completion of follow-up, laboratory tests, dosing at a hospital other than the clinical trial site (level II and above with GCP qualification), or delayed dosing, or express delivery of investigational drugs (including direct-to-patient (DTP) mode), etc. In terms of data collection, we also use eCOA on our company's platform to complete data collection by taking photos and desensitizing the uploaded data, filling in the scoring scale, etc., and returning it to EDC.

Summary

Under the normalization of pandemic prevention and control at home and abroad, clinical trials, clinical monitoring and site management through traditional methods can no longer meet current requirements. In order to maintain or improve the progress of clinical trials, reasonable and compliant open thinking, reform and innovation should be made under the premise of protecting the rights and interests of subjects and safeguarding the quality of clinical study. It's necessary to always pay attention to the requirements of pandemic prevention and control of the site and the real-time release of national laws and regulations. Close communication with the site investigators should be maintained, with a focus on investigational drugs supply, subject follow-up, subject medication and subject safety.

The last point is also very important. "Nothing happens without documentation " means that, the project needs to be well documented and archived as it is being carried out and communicated.

Small Elixir Family classroom, a tiny assistant for fragmented learning around you Currently, we are calling for articles and those whose article is selected can get a prize Welcome to recommend yourself or others Share knowledge Accomplish each other