You want to keep your trial on track, but physical distancing and travel restrictions have made it difficult. Fortunately, IMARC has experience providing remote services.
Research coordinators can bind the clinical research process together to ensure that a trial is efficient and compliant.
With subject safety, protocol and regulatory compliance, and quality data collection being at the forefront of their crucial role, research coordinators truly are vital to clinical research.
Topics: Research Coordinators
As monitors, we spend a decent amount of time preparing for the visit – before we even head out the door. On the road, we’ve noticed that the most effective coordinators tend to be those who also prepare for the visit. Spending an extra hour or two before the visit can decrease the amount of queries, follow-up items and even the length of the visit itself. Before your next monitoring visit, consider asking yourself these five questions:
Topics: Research Coordinators, Clinical Monitors
The informed consent process is arguably one of the most important parts of a clinical research study. From the Principles of ICH GCP: the rights, safety, and well-being of the trial subjects are the most important considerations and should prevail over interests of science and society. Proper informed consent ensures that the patient is aware of the risks and requirements of being in a research study and has voluntarily agreed to participate in research. The regulations, CFR part 50 also cover the importance, rules and process of informed consent.
Topics: Informed Consent, Research Coordinators, GCP
The relationship between a clinical research monitor and site coordinator can play a major role in ensuring data integrity and compliance with applicable regulations. Positive relationships can foster timely data entry, rapid resolution of queries, and adherence to FDA regulations. On the other hand, strained relationships can delay data entry, prevent resolution of queries and lead to sites being less inclined to follow regulations. The coordinator-monitor relationship is critical to the research process as it serves as a link between sponsors, investigators, and regulatory authorities.
Topics: Monitors, Research Coordinators, Improving Relationships
Binders, huge files, and tons of paper….this is what researchers have become accustomed to. Some Sponsors have allowed sites to house certain items electronically, most often communication either emails between the site and Sponsor or IRB communication. But more often than not Sponsors require these items to be printed and housed in files or binders.
Topics: Research Coordinators, Regulatory Binder, Sponsors
During a training module this week, a group of monitors were discussing the importance of back-up coverage. Monitors that are conducting visits in the field know that juggling schedules can be very challenging. To provide thorough and consistent monitoring, experienced monitors are assigned to a clinical trial or a study team. Next, training is extended into the therapeutic area of research and sponsor specific trainings including SOPs and monitoring plans. But what about back-up coordinators - are they trained and ready?
Topics: Research Coordinators, Clinical Monitors, Clinical Research