Best Practices in Pre-Screening Includes Use of Technology
Explore the benefits of pre-screening potential participants before they move on to the informed consent process.Read more
Beginner’s Guide to Medicare Coverage Analysis
Medicare coverage analysis evaluates how clinical research protocol items and services are billed per federal agency guidelines.
Developing and Implementing a Successful eConsent Process
As the industry continues to shift from brick-and-mortar trials to more convenient hybrid formats, eConsent proves to be useful.
Privacy Regulations Impact on Global Clinical Trial Endpoint Adjudication
Endpoint adjudication committees must keep up with rapidly developing requirements as they receive potentially identifiable research data.
Why Now is the Right Time to Adopt eConsent
A valuable tool for both sites and participants, now is the right time for sites to adopt an eConsent platform.
Beginner’s Guide to Budget Negotiation
Proper trial financing ensures internal costs are covered, facilitates better negotiation, and leads to higher compliance in trials.
Beginner’s Guide to Single IRB Mandates
More governing bodies are starting to opt for single institutional review board (sIRB) review as a way to streamline research operations.
Medicare Coverage Analysis Worksheet
Determine whether your trial meets the requirements of the National Coverage Determination (NCD) for Routine Costs in Clinical Trials.
Your Guide to sIRB Mandates
sIRB regulations and policies have been announced and implemented to help address the challenges of conducting clinical trials involving multiple research sites.
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Understanding FDA’s Draft Guidance on Ethical Considerations for Involving Children in Clinical Trials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 Now, FDA provides draft guidance on ethically including kids in trials.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.