Real-world evidence and externally controlled trials play increasingly critical roles in achieving marketing authorizations for drugs undergoing research and development, but sponsors must navigate a diverse body of regulatory guidance documents to prepare for successful regulatory engagements.
This column provides an overview of the Health Insurance Portability and Accountability Act's (HIPAA’s) key data privacy and security measures, along with some steps organizations engaged in clinical research can take to ensure they are in compliance.
Many times, individuals who have triumphed over frightening, or even near-death, situations will say that the experience has given them a new and more positive outlook on life. Allison Massari, a two-time survivor of such scenarios, has an additional and unique insight—and it’s on the patient experience. She celebrates how healthcare professionals have an “exceptional power to transform lives,” and will share her perspective on how compassionate care can be incorporated into clinical research in a Signature Series keynote session tailored for attendees of ACRP 2025 in New Orleans, La., in April.
In light of recent actions by the federal government, ACRP reaffirms our steadfast dedication to supporting you—our association of more than 17,000 members, 11,000 credentialed professionals, and 40 chapters who thrive on collaboration and community, and who champion the safe, quality, and ethical conduct of clinical research.
If there’s one thing clinical researchers can count on when it comes to regulations and guidance from governing bodies, it’s change. In Q4 of 2024 alone, new guidance documents were drafted or finalized on a number of topics.