Bruyndonckx, Robin http://orcid.org/0000-0002-4217-2869
Polkowska-Kramek, Aleksandra
Liang, Caihua
Nuttens, Charles
Tran, Thao Mai Phuong
Gessner, Bradford D.
Begier, Elizabeth http://orcid.org/0000-0002-1287-5416
Funding for this research was provided by:
Pfizer
Article History
Received: 4 December 2023
Accepted: 22 February 2024
First Online: 18 March 2024
Declarations
:
: Aleksandra Polkowska-Kramek, Robin Bruyndonckx and Thao Mai Phuong Tran are employees of P95 Epidemiology and Pharmacovigilance, which received funding from Pfizer to develop this protocol and manuscript. Elizabeth Begier, Caihua Liang, Charles Nuttens and Bradford D. Gessner are Pfizer employees and may own Pfizer stock.
: The study prioritizes the ethical protection of human subjects by using anonymized structured data, negating the need for patient consent. To ensure compliance with ethical standards, local legal or regulatory colleagues are consulted regarding the necessity of IRB/IEC approval or waivers and relevant documentation is forwarded to Pfizer. The study is conducted in accordance with legal, regulatory and scientific requirements, adhering to the Good Epidemiological Practice guidelines issued by the International Epidemiological Association.