Have You Incorporated the Core Competency Domains into Your ePortfolio?

In a wide-ranging ACRP 2016 Meeting & Expo presentation on the value of developing and sharing electronic portfolios (ePortfolios) devoted to demonstrating your clinical research skills and accomplishments to current and potential employers, several experts today raised the utility of using the ePortfolio format for documenting and explicitly tying your experiences to the eight core […]

Consent Concerns Slow Clinical Trial mHealth Adoption

MHealth technology is moving too quickly for regulatory bodies to keep up, according to panelists at the ACRP 2016 Meeting & Expo in Atlanta today. Adoption has been slow in part because consent issues remain fuzzy, said Phillip Coran, Senior Director Quality and Regulatory Affairs at Medidata Solutions. "We're still at a pretty early stage […]

Flawed Site Business Strategy Can Hit Physicians, CROs in the Wallet

The decision-makers in doctors’ offices and contract research organizations (CROs) too often let their enthusiasm for winning a study cloud their business judgment, warns Sabrina Ramkellawan, vice president of operations at Apollo Applied Research. “They need to ask some clear-headed questions before signing any agreement,” Ramkellawan stresses. For example, if a sponsor offers a competitive […]

Placebo Effect Puts Cannabis Clinical Trials at Risk

As if the political, bureaucratic, and moral issues weren’t enough to contend with, clinical trials involving cannabinoids are also struggling with significant placebo effect issues, says Ethan Russo, medical director at PHYTECS. “It’s an increasing challenge that requires the use of innovative trial designs,” he says. There is a perception among the public that cannabis […]

Wide Array of State Laws Can Trip Up CRAs, Sites

The age of consent for a clinical trial is 16 in Texas and 18 in most other states. However, in Minnesota, a pregnant or married person of any age is legally eligible. Welcome to the sometimes bewildering maze of disparate state laws governing good clinical practice (GCP) in trials across the country. “Practitioners don’t always […]