The FDA’s Good Clinical Practice Program (GCPP) fields dozens of questions each year related to completing and signing the Form FDA 1572 — Statement of Investigator. The following are some of the questions GCPP has received recently with answers from the program’s senior analysts. Read More

Sites can add depth to their research teams by creating specialized positions and potentially free up existing staff to take on more trials. The challenge is in site managers or directors convincing site leadership — typically vice presidents — that the gains outweigh the costs. Read More

Although decentralized trial (DCT) approaches have been largely responsible for keeping trials afloat during the pandemic, a major drawback for sites has been not only the number of vendors they require but also sponsors’ failure to consult the sites that will work directly with those technology and service providers. Read More

Sites should take an “all-hands-on-deck” approach to protocol review, engaging all study team members to ensure they’re taking on trials that are well-designed, operationally feasible and devoid of as many pitfalls as possible, according to one expert. Read More