Why Keep HIPAA Separate from the Informed Consent Form
HIPAA is important to the informed consent process, and oftentimes, a standalone document is the most beneficial approach.
Regulatory Trends in Cell and Gene Therapies
Recent signals have indicated the FDA plans to provide greater support for cell and gene therapy research.
Understanding FDA’s Draft Guidance on Ethical Considerations for Involving Children in Clinical Trials
Until the 1980s, children were excluded from research studies. Now, FDA provides draft guidance on ethically including kids in trials.
FDA’s September 2022 NPRMs: What They Mean for Academia and Industry
FDA’s new NPRMs would harmonize certain IRB regulations with the HHS Common Rule. Find out what this could mean for sites and sponsors.
Modernizing Site Feasibility and Selection
An important decision impacting a multi-faceted study startup process is determining which sites to partner with for study conduct.
Unpacking IRB Innovations for Decentralized Clinical Trials
Ethical oversight committees continue to innovate to keep pace with the rapid changes and evolution of research conduct.
How Paper and Electronic Source Data Meet ALCOA-C Principles
ALCOA ensures source data is safe and effective, but how does it differ for data collected on paper vs. electronically?
Strategies for Successful Site Selection in Clinical Trials
While clinical trial site selection aids in a trial’s success, it’s critical to maximize the study's time, resources, and funds.
Keys to Unblocking the Innovation Bottleneck in Research
As the clinical trial industry has evolved in the past decade, it’s invited more complexity into operations and workflows.
Informed Consent Writing Tip Sheet
Informed consent is a centrally regulated protection for research participants. Learn the regulatory requirements for providing it.
How the IND 30-day Hold Impacts Clinical Trial Activities
Find out what research activities can and cannot be conducted during the Investigational New Drug (IND) 30-day hold period.
Streamline Study Startup with Improved Site Selection & Feasibility
Identifying the best prepared and performing sites for a study is essential to success. Explore strategies to improve site selection and feasibility.