I reached the hospital today at 8:35 am sharp.
The reason for reaching so early, you ask? Wait, let me narrate the eventful day I had today...
Early in the morning, at 5:22 am, my phone started ringing frantically. First I thought that it was my usual morning alarm and chose to ignore it, but the phone just wouldn’t stop. I jumped out of my bed to answer the call.
It was the wife of one of our patients. This patient – let’s call him XYZ - has been enrolled on a prostate cancer trial for the last couple of months. The wife was crying and was trying to explain something in what seemed to be half Kannada and half Hindi. I realized that something must have gone wrong, so I tried to pacify her with a few consoling words and asked her what exactly had happened. Her husband had a high fever and had fallen unconscious moments ago, she said.
I quickly instructed her to bring him to the hospital and assured her that I would inform the doctor on duty as well as the PI (Principal investigator), so that they would decide the further course of action.
I called up the hospital casualty and informed the doctor, as promised. I tried to call the PI as well, but finding his phone switched off, sent him a detailed text message instead.
I had a quick glance at my Outlook and realized that there was a monitoring visit and two mandatory trainings that I was supposed to attend today. If this was not enough already, I had three patient visits scheduled for and had planned to look at an IP accountability in my spare time... It was going to be a busy day, indeed!
Taking into account the emergency with patient XYZ as well as all the tasks I had lined up for the day, I settled for two slices of bread for breakfast. I got ready as quickly as humanly possible, and after grabbing a quick cup of tea, started for my workplace. Luckily, the traffic was modest and I punched in at 8:35.
I inquired about the patient’s room number only to find that he was in the ICU since his vitals were compromised. I went there, went over his file, made a note of important medical events, spoke to a relative of his and went to meet the PI’s assistant.
On my way there, I made a mental note of reporting this incidence as an SAE (Serious Adverse Event). I requested the assistant to inform me the moment the PI came around, so that I could get the required details about the event from him.
By the time I returned to my desk, it was already 9:20. I thought of going through the site master file once, to facilitate the monitoring visit that was planned for today. Just as I started going through the pages, one of the PI’s - a paediatrician - called and informed me that one of his patient’s parents wished to come for an informed consent today and that I should accompany him for the consent process. When I gathered that the child was merely four, “no assent form required”, I said to myself. I instructed our office assistant to set up the video recorder for recording the consent of the patient’s parents, who came shortly after. They turned out to be educated and well informed, putting an end to the need of calling an LAR (Legally acceptable Representative).
In the meantime, the monitor came. I greeted him and showed him into the monitoring room. I handed over all study-related files to him and told him that I would be available to clarify any queries that might arise.
My desk phone rang and the assistant doctor informed me that the PI under whom XYZ was admitted was finally on his round. I practically banged the phone into the receiver and rushed to the ICU. XYZ’s initial reports had arrived with the conclusion: Absolute Neutropenia... No wonder he had such a high fever. The doctor prescribed him antibiotic and ordered more investigations. He informed me that we would defer the patient’s next chemo cycle by at least two weeks.
I went back to my workplace to be informed that a patient whose visit had been due was waiting for me in the waiting lounge. I smiled at him and asked him about his health. I quickly glanced over the printout of an excel sheet pinned above my desk to mentally refresh everything that needs to be done on visit 4. Then I instructed the study nurse accordingly and asked the patient to complete all required investigations and sampling.
After a while, he returned the empty strip, and I dispensed him the next lot of medicines, that would last him till his next visit. I went to the monitoring room next, after seeing the patient off. By that time monitor had couple of questions he needed resolved by me, and I sat down to do just that.
It was almost 1:45 pm now, and I realized that I had not had my lunch yet. I went to the canteen, where I had to wait in a long queue. By the time my turn came, my mobile rang, informing me that the parents of the aforementioned four year-old had come for consenting.
I asked the canteen guy to parcel my food to carry with me to my office and bought a Cadbury Dairy Milk for the little patient who had come to participate in the trial.
The PI came after a bit and we started informing the parents about the study, schedule, safety information, visits, blood draw, et cetera. Quite naturally, they had a lot of concerns and questions about the study and randomization procedure,which were duly clarified by the PI, who never lost his patient, unaffected bearing once, although he had been through this at least a hundred times before. Finally after about an hour and a half later, the ICF was signed. I checked it thoroughly to make sure everything was in order, gave one copy to the parents and went to complete IC documentation. Before leaving, I instructed our office assistant to save the video recording and keep the encrypted copy as per our SOP. This process has taken almost two hours and our little patient was fast asleep on a small couch in the waiting area by the end of that time. I handed chocolate that I had bought for him to his parents.
Finally, I had my lunch at 4 pm. The rest of the day was relatively less busy. One of the patients who was to come for a scheduled visit rang, requesting me to allow him to come the next day instead. Luckily, a visit window was open for that time, and I granted his request, reminding him not to miss it.
A third patient whose visit was scheduled came on time, but because it was a follow up visit, there was hardly much to be done.
I quickly glanced at the SAE notification communication and went to the PI’s OPD to get his signatures. I managed to sneak in between two of his appointments and my work was done in 10 minutes.
I went back to my desk and decided to complete my mandatory online trainings. I logged in and completed one training. Just as I was finishing it, the monitor called me for closing remarks. I decided to complete the other training on a later date, updated my calendar and went to the monitoring room.
It was 7:30 pm when I finally shut my PC down.
That was a typical day for me, as a CRC. However hectic my schedule might be, at the end of the day, I feel satisfied, self actualised, like I have contributed my share for a greater cause... and that is what drives me to face the next day with equal zeal and enthusiasm.
-Manjiri Joshi, CCRA
Director, Ukaat Consultancy and Services Pvt Ltd.
Senior Consultant, Sahyadri Clinical Research & Development Centre
manjirinitin@gmail.com
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