June 6, 2016

ACRP Training and Development is hosting a live webinar on how to streamline over-reporting to IRBs.

IRBs are over-burdened with reports not required by federal regulation. Study sites are often confused about reporting requirements and err on the side of "caution" by over-reporting.

June 3, 2016

The FDA has released new guidance with regards to the use of electronic health record data in clinical research. You can find the guidance using the link below:

June 3, 2016

Explore the statutory and regulatory provisions governing FDA standards of safety and effectiveness, including its flexibility in applying the standards. This webinar will focus on the four types of clinical outcome measures: Patient-reported outcome (PRO), clinician-reported outcome (ClinRO), observer-reported outcome (OBsR), and performance outcome (PerfO).

May 12, 2016

Find out what's going on within the industry with the ACRP blog!

Lack of standardized competence putting clinical trials at risk
https://acrpblog.org/2016/05/10/lack-of-standardized-competence-putting-...

January 19, 2016

Do you have questions about the Trial Master File Reference Model? The TMF Reference Model provides standardized taxonomy and metadata and outlines a reference definition of TMF content using standard nomenclature.

October 29, 2015

It's always difficult as a Sponsor to delegate specific tasks to a CRO. However, when looking at it from an overall point of view, it is always good to review to obligations under 21 CFR Part 312 and ICH GCP E6 when transferring responsibilities. Below are some regulatory guidance to consider: