Research Compliance

COVID-19 Pandemic: An opportunity in digital transformation for research teams

COVID-19 has significantly impacted research study operations, particularly in the realm of IRB meetings and processes. The pandemic necessitated a rapid shift to virtual meetings using platforms like Zoom and Google Meet. While digital technologies provided flexibility for remote work and virtual subject enrollment, studies requiring physical presence faced challenges. Key Solutions offers recommendations and best practices to navigate these changes, including provisions for virtual visits, remote monitoring, and protocol flexibility.

COVID-19 Pandemic: An opportunity in digital transformation for research teams Read More »

eRA, IRB

Transitioning your stem cell research from complexity to compliant: More progress with minimal paperwork

In a digital age, laboratories can revolutionize their compliance infrastructure with digital compliance solutions. These solutions enhance collaboration, streamline documentation, and simplify the review, approval, and audit lifecycle of research work. This is especially crucial for stem cell research, which must meet stringent regulatory requirements. Key Solutions offers a comprehensive SCRO module that facilitates compliance for stem cell research by providing complete version control, audit trails, and integration with other compliance modules.

Transitioning your stem cell research from complexity to compliant: More progress with minimal paperwork Read More »

Compliance, eRA, Research Compliance
Post Approval Monitoring

Post Approval Monitoring- Comprehensive and Integrated Research

Post Approval Monitoring (PAM) is crucial for ensuring that research involving humans and animals adheres to regulatory requirements. PAM involves the IRB and IACUC, which set guidelines for research protocols to protect subjects. Key Solutions offers integrated PAM software that streamlines compliance processes, allowing researchers to focus on their work while maintaining adherence to protocols. The software’s features include assigning inspections, recording processes, and ensuring compliance with IRB and IACUC standards, enhancing the credibility and effectiveness of research.

Post Approval Monitoring- Comprehensive and Integrated Research Read More »

Compliance, eRA, Research Compliance
Common Rule

The Common Rule

Human Subjects Research: Individuals who are the subjects of research will be asked to contribute their time and assume risk to advance the research enterprise, which benefits society at large. U.S. federal regulations governing the protection of human subjects in research have been in existence for more than three decades. The Department of Health, Education,

The Common Rule Read More »

Common Rule, IRB

A Fast-track approach to COI process automation

Existence (or assumption) of a Conflict of Interest (eCOI) has the potential to jeopardize a research project and tarnish the reputation of the research organization conducting the investigation. An important part of research administration is to eliminate existence of COI before it can have a damaging effect on the study being performed. As a part

A Fast-track approach to COI process automation Read More »

Conflict of Interest, Research Compliance
IRB

Improving IRB Performance

Institutional Review Boards (IRBs) are assigned with the critical job of reviewing, approving, and monitoring research involving humans. One of the main responsibilities of an IRB is to protect the rights and welfare of human subjects from harm – be it physical or psychological. With such responsibility resting on their shoulders, it is imperative that

Improving IRB Performance Read More »

IRB, Research Compliance

Quick Guide To Biosafety Management

Biosafety can be defined as the application of information, techniques, and equipment to prevent potentially infectious and/or hazardous biological materials from harming people and the environment. Biosafety measures delineate the conditions under which biohazardous materials and agents can be safely handled. Biohazardous materials could be microorganisms, toxins, body fluids, controlled substances, allergens, carcinogens, oncogenic matter,

Quick Guide To Biosafety Management Read More »

Institutional Biosafety Committee, Research Compliance
Scroll to Top