Product Details

Voicing Site Hopes and Frustrations with EDC

Investigative sites are highly receptive to the promise of EDC solutions. However, current trials that use EDC technologies appear to be increasing workload, are fraught with technical problems, lack adequate training and support, and often involve paper-based approaches in anticipation of EDC failures. Sponsors and CROs report higher levels of sensitivity to investigative site EDC needs and capabilities. More than 25% of sites report that sponsors are increasing grant amounts to compensate for additional workload. And nearly 60% of sites report that their experience with EDC factors into sponsors’ site selection decisions.

Projecting HIPAA’s Impact

The majority of investigative sites report that they are prepared to be HIPAA compliant under the mandated Privacy Rule. Sites have focused their preparation on personnel training, creating new standard operating procedures and establishing new internal roles and functions. In clinical research, HIPAA is most expected to impact the informed consent process and patient recruitment. Variations in interpreting the HIPAA Privacy Rule are contributing to high levels of uncertainty and confusion that may result in delays and increase the likelihood of HIPAA non-compliance.

Also in this issue:

• Emerging CRA Specialization in Europe
• Eye On: Urinary incontinence