Clinical Research Emergency Response Guide

First protect the life safety and legitimate rights and interests of the subjects, then maintain the bottom line of research ethics and compliance, and finally complete the integrity and traceability of the research data - without any exceptions.

Believe it or not, the first reaction of a new CRA when encountering a serious adverse event (SAE) is to review the plan and check the reporting process. By the time he has completed half of the plan, the prime time for rescue has passed. Last year, our center was conducting a phase I trial of an anti-tumor monoclonal antibody. One subject was out of breath after 30 minutes of administration, and his blood oxygen dropped directly to 87. The young CRA who had just joined the field took out the case report form and started to record it. The PI grabbed him and said, "Save the patient first, and we will talk about the recording later." ”Later, when this group of people reviewed the results, they even had a quarrel. The quality controller who came from an agency office felt that even if he was rescued, he had to have a dedicated person to synchronize the records, otherwise the data would not comply with the regulations. ； The PI with a clinical background slapped the table directly: “What’s the use of compliance if there are no people? ”In fact, there are no unified requirements for the processing scale of this scenario in the industry. The NMPA's updated guidelines in 2023 only mention "ensuring data traceability." As long as the subsequent supplementary recording includes cross-verification of medical staff participating in the rescue, and is clearly marked with "supplementary recording" and the specific time, neither processing method will be judged as a violation.

I always have a printed emergency address book stuffed in my bag. From the PI, the ethics secretary, the director of the institutional office to the contact person at the 120 emergency center, everything is printed on it. When something happens, I can take it out and type. It is three times faster than flipping through the address book on my mobile phone. Don’t laugh, your hands will shake in real emergencies and you can’t even slide your phone away. Last time, the little CRC I was taking care of encountered a subject who went into anaphylactic shock. She stood on the edge and burst into tears. It was the old nurse who reacted first and pushed the ambulance. Later, I told her that it’s okay to cry. After crying, call 120 first, then call me. Everything else will be discussed later. No one blames you.

In addition to this kind of SAE that is directly related to human life, there are many less eye-catching emergencies that can bring the entire research to a halt if not handled well. Last month, the refrigerator of a central pharmacy in the West District tripped in the middle of the night. The temperature of the experimental drugs stored at 2-8°C rose to 10°C. When the administrator came in the morning and saw it, he was shocked. The first reaction was not to blame the CRA. He first moved all the experimental drugs to the backup refrigerator. Remember the transfer time, the location of each box of drugs, and the time before the transfer. After taking the latest temperature reading, we asked an electrician to investigate the cause of the trip. Finally, we asked a statistician to evaluate with the sponsor to make sure that the duration of the batch of drugs affected by temperature did not exceed the threshold of the stability data before continuing to use it. If we panic and hide it first, problems will arise when the subjects use it, and the entire project will be cancelled.

Oh, by the way, there is another type of emergency involving privacy, which is much more troublesome than medicine breaking or data being lost. Previously, a CRC at a center encountered a subject who was found to be pregnant after a screening. The girl was not married yet, and her best friend was accompanying her at the time. The CRC quickly said, "You can't join the group because you are pregnant." The girl fell out on the spot and almost sued for invasion of privacy. When encountering this kind of thing, the first principle is to remove the irrelevant personnel first and communicate with the subject alone. If you want to notify your family or work unit, you must first obtain her written consent. I don’t know how many newcomers have stepped into this trap.

Nowadays, many newcomers always think that they have to memorize a whole set of SOPs for emergency response. In fact, it is really unnecessary. I have been working in clinical research operations for 8 years, and I have seen too many people rush to find documents and leaders beforehand, which in turn delays the most important things. Of course, I don’t want you to be reckless. Within 24 hours after the emergency response, you must compile the entire process into a written record. Who did which step, what time point, and whether there are any special circumstances. Write them all clearly. Whether it is for ethics reporting or follow-up drug regulatory review, things written in black and white are always more effective than words.

In fact, there is no perfect guide. Clinical research is a job of dealing with people, and there are so many variables that you can’t imagine. When you are really unsure about something, just touch your chest and ask three questions: Have the safety and rights of the subjects been compromised? Is there any ethical violation? The first two are no problem. If you think about data and compliance, you will basically not make any mistakes in principle. After all, we are in this business fundamentally for people, not for those piles of forms that are taller than people.