You're a clinical program lead. A site PI wants to enroll a patient who, you believe, doesn't clearly meet inclusion criteria — but borderline. The sponsor wants enrollment up. What do you recommend and to whom?

Question

Answer

Stay specific. One example, told well, beats three told fast. Make your decisions visible — what you chose between. End on what changed, for whom.

You're a clinical program lead. A site PI wants to enroll a patient who, you believe, doesn't clearly meet inclusion criteria — but borderline. The sponsor wants enrollment up. What do you recommend and to whom?

Practice more