Oncology studies present unique challenges to clinical researchers and auditors in meeting FDA compliance expectations due to aspects such as high mortality rates and extensive source documentation.
Audits of study sites operating under an IND are focused on site compliance with both ICH-GCP and FDA regulations. The objective of the audit is to assess patient safety and data integrity, and secondly ensure that investigator sites are inspection ready. Sites must have a good understanding of the industry standards in place to ensure compliance. These standards include: good clinical practices based on ICH and good documentation practices encompassed in the ‘ALCOAC’ standard. When an oncology site is conducting a study under an FDA IND, it is valuable for the investigator and staff to know the subtle differences between ICH GCP and FDA regulations, and to be aware of the additional challenges unique to oncology studies due to the setting and nature of these trials.
There are four types of letters issued as a result of an FDA inspection, three of which indicate non-conformances that require a quick and professional response with appropriate explanation of corrective and preventive action (CAPA) plans. An auditor may assist investigational sites in learning how to avoid a Form FDA-483 and non-conformance letter by ensuring appropriate implementation of industry standards.
By understanding of the challenges of conducting oncology clinical research and the expectations unique for FDA regulations, oncology study teams are able to be optimally prepared for both a sponsor audit and/or an FDA inspection.