PPTA Donor History Questionnaire

The PPTA Donor History Questionnaire represents nearly a decade of collaborative work on the part of PPTA staff and member companies, working in conjunction with the AABB, which is an international organization of blood banks, and the U.S. Food and Drug Administration, that has resulted in standardized forms that are intended to be used to obtain medical histories from donors of source plasma, a starting material for the manufacture of plasma protein therapies. PPTA member companies operate more than 400 International Quality Plasma Program (IQPP)-certified source plasma donation centers across the United States. Additionally, PPTA is hosting an implementation workshop on June 14, 2010 in Reston, Virginia in connection with the Plasma Protein Forum.

The U.S. Food and Drug Administration (FDA) maintains all officially recognized versions of the Donor History Questionnaire (DHQ).  At this time, FDA has not officially accepted the PPTA DHQ but has provided “preliminary” approval. FDA has termed this as "preliminary" approval due to the guidance development process, which may result in changes to the questionnaires and/or accompanying materials before final publication.  FDA currently is developing draft guidance, which will be published for public comment over the next several months.  Companies that implement the PPTA DHQ materials, before issuance of FDA final guidance, must submit materials as a Prior Approval Supplement (PAS). Additionally, it will be necessary to review the FDA final guidance once published to ensure that companies are in compliance. Once final guidance has been issued, companies will be able to implement the PPTA DHQ and report the change to FDA in their annual reports.

PPTA Donor History Questionnaire Version 1.0* October 2009

Full-length DHQ 1
Full-length DHQ 2
Full-length Directions for Use
Abbreviated DHQ
Abbreviated Directions for Use
Medication List
Risk Poster 1
Risk Poster 2
Travel Poster 1
Travel Poster 2

*This version has NOT been officially recognized by the FDA.