Over the past few weeks, the entire world has been focused on the COVID-19 pandemic. With over two hundred thousand confirmed cases and counting, this global crisis has been affecting socio-economic environments and industries across the board, including the research industry.
Clinical research coordinators and monitors have experienced cancellations of on-site visits at clinical research sites worldwide and sponsors and CROs alike have canceled international travels for their employees. Visit cancellations have been affecting monitoring plans, which can result in protocol or SOP deviations and have a negative impact on the data verification that would normally be conducted on-site.
In addition to hospitals canceling site visits, patient appointments have either been rescheduled or additional evaluations have been conducted from temperature checks to pre-visit phone calls to ascertain patient wellness prior to their arrival at the research sites. In instances where a patient is turned away due to a cough or runny nose, there may be a missed or additional visit and non-related adverse event (AE) reports. These special circumstances may lead to multiple ICF revisions, deviations, as well as inconvenience for the patient.
In order to minimize risks while maintaining data quality, it is recommended that clinical research professionals utilize electronic data capture (EDC) systems. With risk-based approaches requiring the adoption of a combination of both centralized and on-site monitoring, these steps should be taken before it becomes a necessity. Since monitors’ on-site visits are largely focused on ensuring the quality of study documentation, assessing drug accountability, and confirming the sites’ familiarity with the protocol, use of EDC systems is crucial in order to capture these details and maintain data quality. In addition, source data verifications (SDVs) can and should be performed via an EDC. By not using an EDC system, clinical research coordinators may be overwhelmed with time-consuming tasks such as altering existing report templates, de-identifying source documents, and utilizing email and fax machines. These consequences may ultimately impact the quality, cost, and efficiency of clinical research endeavors.
Furthermore, with an EDC system, eCRFs can be used to upload consent forms, which may contain test material distribution and collections. In addition, EDC systems enable clinical research professionals to conduct compliance checks and validations, and the tools help ensure that only personnel listed on the delegation can perform the assessments.
To learn about how Castor can partner with your organization in decentralizing trials so they can continue running during this pandemic, get in touch with our team at [email protected].
