Our Output

1.     We added a welcome letter to explain the purpose of the Informed Consent Form, and to emphasize the fact that participation is voluntary. It helps potential study participants feel that this document is designed with them in mind.
2.     We visually formatted a table of contents to help the reader navigate information in a manner more intuitive to them. While all key regulatory requirements for informed consent are provided, the tiered delivery of information gives the readers autonomy to choose when to look deeper into a topic.
3.     We used visual charts and diagrams throughout the Informed Consent Form to visualize the content and help break down complex concepts.
4.     We created support materials to explain how the ICF fits into the larger clinical trial context. The “Study participant’s discussion guide to cancer clinical trials” provides background information about cancer clinical trials in general, and equips potential study participants with important questions that they might want to ask their study team. The “Study participant’s contact sheet” provides an overview of the clinical trial participant’s study team, and identifies those individuals who are directly and indirectly involved in their care.

SAFTINA and KURASITAL are fictional drugs, and do not exist as treatment for any kind of medical condition(s). Any similarity to actual drug development program(s) (past, present, or future) by Bristol Myers Squibb or any other organization is entirely coincidental.