Today was day 2 of the GMP FACT inspection. My day started out rather slow because the inspector was not there when I arrived. Thus, I was able to shadow a coordinator whose job was to keep parents of potential clinical trial participants updated. I watched as she answered emails with questions from the parents. Much of the work was repetitive, often involving repeating the same information back to recipients. Many of the people who contacted the coordinator were very well informed. I learned that there are websites as well as facebook groups that are created to inform the public about these trials. Because Duke has a policy where they cannot voluntarily reach out to patients, the people interested in these studies have to proactively seek out such opportunities.
In the afternoon, I shadowed Dr. K as she and her team received the results of the GMP inspection. Though I had heard from others that this particular inspector was very thorough, I can only agree with the others. The inspector had caught onto every detail. They even went as far as to examine the labels of storage bins, saying that they needed to be dated and timed. Afterward, I observed as Dr. K ordered a prescription for a patient. This particular patient needed an antibiotic for an infection. Based on the patient’s weight and age, Dr. K calculated the dosage needed. I ended my day by helping sort through old patient files. Most of these files were from past clinical trials and needed to be sorted as a backup.
Overall, these past days were very enlightening. I was able to see the whole process of caring for a patient and am inspired to learn more about the medical field.