What is a chain of custody in clinical trials or investigations?

• A. Documentation showing custody and control of specimens/data; ensures integrity and admissibility.
• B. A log of who has used the data in the study.
• C. A permit to conduct the trial.
• D. A patient consent form.

Answer: (A)

Chain of custody is the documented, unbroken record of how a specimen or data has been kept, handled, and transferred from collection to final disposition. In clinical trials or investigations this means capturing every step: who collected the sample, when and where it was collected, how it was labeled, who stored or transported it, how it was stored (conditions, security), and who accessed or analyzed it along the way. This continuous trail ensures the integrity and authenticity of the material or data and supports its admissibility in audits, investigations, or court proceedings. The description that matches this idea is the documentation showing custody and control to maintain integrity and admissibility.

A log of who has used the data is related to data governance, but it does not by itself establish the full custody trail for specimens or evidence. A permit to conduct the trial pertains to regulatory approval, not the chain of custody. A patient consent form concerns ethical participation, not the handling and transfer of evidence or data.