January 15, 2018

Common Rule Confusion Clouds Industry Preparedness

As the January 19 implementation date of the revised Common Rule approaches, the question remains as to whether or not implementation of the revised rule will be delayed — leaving many feeling uncertain.

The Pulse on Study Conduct

Educate yourself on new therapeutic areas

Medical knowledge for the vast assimi­lation of clinical research guidelines is necessary for anyone entering the field. The diverse regulatory landscape requires us to stay abreast of changes that impact patient safety data. It is a multifaceted learning process with educational requirements that vary by role. We should never expect anyone to have every answer, or to know everything about a protocol/therapeutic area. That sets an unreal­istic standard that undermines performance.