Managing Investigational Devices According to GCP Requirements

Question 1

Blinded Trial

Answer 1

a trial divided into more than one experimental group where subjects are not told which group they are assigned. For example, subjects in one group might receive Device A and subjects in another group might receive Device B, and none of the subjects are told which devices they have received.

Question 2

Randomized Trial

Answer 2

a trial in which subjects are randomly (by chance) assigned to one of two or more arms of a clinical trial. Occasionally placebos (or “sham” controls and procedures) are utilized, but this is obviously more difficult in device trials than in drug trials.

Question 3

limits on device propagation

Answer 3

The sponsor is required to ship the investigational device only to qualified investigators participating in the investigation.
The devices must also be stored in a secure location that is accessible only to authorized personnel
Each product should be accounted for through use of the protocol-specific investigational product accountability log

Question 4

double blinded

Answer 4

neither the investigator nor the subject knows which treatment the subject is to receive.

Question 5

device accountability

Answer 5

Device accountability is reconciled by reviewing the paper trail:

Shipping records showing receipt of the investigational device
Records showing usage of the device with subjects
Reconciliation records for unaccounted-for devices
Final disposition records