Important Updates

New eConsent Implementation Guidance & Tools

The eConsent Initiative has developed practical guidance and tools describing potential implementation considerations and eConsent components. Check out our eConsent Initiative Asset page for more info.

New Common Protocol Template Materials and Video!

The Common Protocol Template Initiative launched its tech enabled protocol template in alignment with the FDA and NIH. Check out our CPT Initiative Asset page for helpful materials and our brief overview video.

New Implementation Tools and Guidance Papers for the CDT Initiative

The CDT Initiative now has new implementation tools and guidance papers available via download.

Optimizing the Use of Electronic Data Sources in Clinical Trials

The eSource Initiative published its first landscape paper, Optimizing the Use of Electronic Data Sources in Clinical Trials. Read it here.

Infographic: QMS Initiative’s Conceptual Framework

This infographic reviews our conceptual framework for a clinical QMS. Take a quick look and then read our latest article in TIRS.

Check out our new PSoC Initiative mission video

Our PSoC Initiative video describes the expected benefits for the clinical trial industry.

Common Protocol Template Now Available

Resources for our new Common Protocol Template is now accessible via download

The PSoC Initiative’s Database Update

New White Paper on the Development and Implementation of a Pharma-Collaborative Large Historical Control Database.

The RBM Initiative Presents New Risk Indicator Library

We have a new Risk Indicator Library from our Risk Based Monitoring Initiative. Check it out!

Data De-identification & Anonymization White Paper From the Data Transparency Initiative

Review our Model Approach to Data De-identification and Anonymization of Individual Patient Data in Clinical Studies