Managing Risk - continued

“Gray-area” Requests (including protocol waivers)

“Gray-area” requests refer to directives to perform activities in areas where current regulations provide vague or no guidance. These requests can be complicated, particularly within the many outsourcing models utilized by Sponsors and CROs which are surrounded by inconsistently interpreted regulations regarding delegation of authority.

Regardless of the Sponsor or CRO size, the demands of today’s competitive business environment and safety-sensitized consumer market create tremendous pressure on industry professionals to deliver—and to deliver more and more quickly. The joint effort of the Sponsor and CRO partner in the best case, produces a marketable product, from which the Sponsor derives significant income. However, the CRO’s motivation in the interaction is significantly different, as its only sellable products are staff and reputation (as viewed by the Sponsor organizations for which they render services).

This variance of motivation that exists between Sponsor and CRO may present difficulties, particularly given the trend toward increased outsourcing. These “gray-area” requests come more frequently from newer/smaller companies without institutional historic wisdom mandating caution regarding interpretation of product development regulations.

“Protocol waivers” represent an excellent example of a “gray-area”—operational staff are caught between perception of regulations, reality of service delivery, and precedent. Formally documented policies dictating that which is appropriate in resolving these situations before they occur are a critical component of a well formulated Risk Minimization strategy.

Waivers

Until the early 2000s, the construct of “protocol waivers” was universally understood, and commonly accepted within the industry.

“Protocol waivers” have fallen out of favor for a variety of reasons including the abandonment of the ITT analysis for registration, as well as the public’s sensitization to situations in which