Abbreviated Donor History Questionnaire: Background and Introduction. Sharyn Orton, Ph.D. OBRR/CBER/FDA Blood Products Advisory Committee March 2005. Background. AABB Donor History Questionnaire Task Force 2001: TF submitted to FDA a proposal to revise the full length questionnaire
Sharyn Orton, Ph.D.
Blood Products Advisory Committee
AABB Donor History Questionnaire Task Force
Concept has always been endorsed by FDA:
1. Does the committee agree that the proposed study design (exclusive of sample size) is adequate to reasonably demonstrate equivalence (or lack of equivalence) between the two capture questions on the abbreviated questionnaire, and the 17 specific questions on the full-length questionnaire?
2. If yes, does the committee agree that the proposed sample size is adequate?
3. If no, what alternative study design and/or sample size does the committee propose would be adequate?