An SME biotechnology company wishes to perform exploratory research assays in-house using human samples obtained from ongoing clinical trials and healthy volunteers. The samples include blood and serum. No DNA analysis will be performed on these samples. The in-house laboratories do not operate to a defined quality standard. However, standard operating procedures are in place to make sure that samples are only used within patient consent and that a sample handling system is in place to mimic a GCP laboratory as much as possible. In all cases the clinical samples are being sent from the clinical trial site to a GCP compliant central laboratory first. The purpose of the testing is to improve understanding of clinical data generated, investigate mechanisms of action and understanding of biomarkers. Given procedures are in place to mimic GCP sample handling and the exploratory nature of the work, is a GCP accredited laboratory considered a requirement to perform such analysis?

The company confirms that:

Patient consent regarding sample handling and testing will be obtained as appropriate
Patient confidentiality and anonymity will be maintained at all times.
The exploratory analyses are not part of any primary and secondary study end points
Data is not required for registration package or Clinical Study Reports but may be included in publications.