Ways to Streamline Informed Consent Process in Clinical Trial Startup
At a busy research site, a clinical trial is ready to launch — but it’s stuck in limbo over a […]
Informed Consent
The Regulatory Binder Checklist For Clinical Trial Sites
A regulatory binder is essential for managing clinical trial documents, ensuring regulatory compliance, and facilitating audits. It organizes critical documents;
Optimizing Your Human Research Protection Program: The Role of Quality Training
As research institutions are designing studies and recruiting participants for them, they must maintain compliance and ensure their study is
Developing and Implementing a Successful eConsent Process
eConsent simplifies the consenting process for research staff and participants, improving quality and reducing audit issues, especially in hybrid studies.
Why Now is the Right Time to Adopt eConsent
eConsent streamlines trial participation, allowing remote access and minimizing paperwork errors, benefitting both research staff and participants alike.
Why Keep HIPAA Separate from the Informed Consent Form
The research informed consent form (ICF) is designed to provide prospective participants with the necessary information to make an informed
FDA’s September 2022 NPRMs: What They Mean for Academia and Industry
On September 28, 2022, the Food and Drug Administration (FDA) released two Notices of Proposed Rulemaking (NPRM). These notices proposed
Informed Consent Writing Tip Sheet
Crafting informed consent forms requires balancing regulatory compliance with participant understanding, ensuring consent is both meaningful and legally sound.
Regulatory and Ethical Considerations for eConsent in Research
IRB oversight, identity verification, and comprehension checks are critical in eConsent, ensuring ethical and legal standards while improving participant understanding.
Enhancing Research Conduct Using eConsent
eConsent in clinical trials enhances participant understanding and flexibility but requires careful planning, regulatory compliance, and IRB coordination to ensure success.
Short Form Consents and the Unexpected Non-English Speaking Participant
Short form consents provide a crucial bridge for unexpected non-English speaking participants, ensuring informed consent remains accessible when translations aren’t readily available.
Beginner’s Guide to eTMF, eISF, and Regulatory Research Documents
Efficient document systems like eTMF and eISF enhance compliance and streamline document management, helping sites and sponsors ensure secure, organized trial records.