Protocol Diagnostic 101: How to assess your protocol for implementation risks
Protocols are like babies…and no one wants to tell someone their baby is ugly.
But, when sponsors are so closely focused on the protocol, sites bear the brunt of overly complicated and/or unrealistic elements that remain in poorly written (a.k.a “ugly”) protocols. This burden not only leaves a sour taste in your site’s mouth but also leaves your study execution and data at risk. Protocol comprehension touches your study from day one and has the power to make or break your study timelines and budgets.
- Review tactics and approaches dissecting protocols for clarity, consistency and true operational feasibility, so that sites are able to execute the study — reducing risk, deviations and amendments
- Critique (“analysis”) of some poorly written protocols (“Protocol Bloopers”) while learning what potential rewrites could look like
- Discuss the effectiveness of proactive approaches and the available tools to mitigate or prevent the compounding effects of having an ugly protocol
- Beth Harper Chief Learning Officer at Pro-ficiency
- Jennifer Lee VP, Clinical Operations and Data Management at Elevar Therapeutics
- Robyn Griffith VP Clinical Science & Operations, HPV and Oncology at Inovio Pharmaceuticals, Inc