Adapting investigational drug services during a pandemic: Recommendations for future preparedness from the Hematology/Oncology Pharmacy Association Investigational Drug Services Special Interest Group

Abstract

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Navigating the challenges of clinical trial professionals in the healthcare sector

“…Some specifications about the pharmacist’s responsibilities in CTs are described in the GCP ( 3 ), which defines the need for dispensing records kept at the pharmacy and notes that an investigator should delegate responsibility for the storage and accountability of investigational products to an appropriate pharmacist. In the United States, the Code of Federal Regulations defines issues related to investigational product management ( 163 ).…”

“…Site qualification visits, site initiation visits, sponsor monitoring visits during a clinical trial, mailing of oral investigational products to patients, and virtual sponsor audits have been widely implemented following the coronavirus disease 2019 (COVID-19) pandemic outbreak and are now standards. Its use must be adapted to the characteristics of each CT and patient ( 163 ).…”