Identify potential barriers to inspection readiness in relation to site inspections in clinical trials.

Opening your clinic in the morning requires assurance that all equipment and Point of Care Tester (POCT) materials are available and functioning properly. What quality assurance measures would you have in place for your office?

When a patient with suspected pneumonia is admitted, it is expected that blood cultures and a chest X-Ray are done right away. This assures quicker and more accurate diagnosis or confirmation of diagnosis. (1) identify the performance improvement opportunity; (2) determine whether the issue is mostly related to a structure or process aspect or the interaction between the two; (3) explain the performance measure you would focus on along with the data you would collect; and (4) any benchmarks you would follow.

The primary purpose of random assignment in a clinical trial is to    help ensure that study subjects are representative of the population   help reduce detection bias   help ensure the study groups are comparable pre-intervention   facilitate adherence to the intervention   facilitate measurement of the outcome variable   all of the above