Clinical research emergency response guide pdf

> [Core conclusions first] This guideline PDF can directly cover more than 90% of the emergency situation handling needs in the entire clinical research cycle. The core handling principles are "subject safety first, compliance bottom line is not loose, and the entire chain leaves traces." It contains 4 types of core scenario handling flow charts and 12 directly applicable reporting templates. All content is derived from the summary of more than 3 years of practical experience of GCP centers in 17 tertiary hospitals across the country, and there is no empty theory.

When I first started doing CRC two years ago, I encountered something that left a deep impression on me: On the third day after taking the experimental drug, a subject with advanced lung cancer fell while riding an electric bike to buy groceries and suffered an open fracture and was sent to the emergency department. At that time, the PI was holding an academic conference out of town, and the ethics secretary couldn’t get through on the phone. My hands were shaking while I stood in the emergency corridor. I turned out this guide and scanned two pages before I could stabilize myself. Come down - first communicate with the emergency doctor to try not to use antibiotics that may interfere with the metabolism of the trial drug, and simultaneously make an emergency call to the sponsor's medical department. All calls are recorded. The subsequent SAE report includes all the emergency registration forms and payment vouchers at that time. In the end, the compliance red line was not violated at all, and the subjects recovered well.

To be honest, no one will follow the rules and regulations when encountering an emergency. This guide has marked the most panic-provoking scenarios. The first priority items marked in red are all related to the safety of the subjects, and there are not so many false requirements. Of course, there is also a point that has been controversial in the industry for a long time: regarding the time limit for reporting SAEs, the SOPs of some leading pharmaceutical companies require that SAEs that may be related to the trial must be reported to ethics, NMPA and all participating research centers within 24 hours. There are also many grassroots GCP centers that believe that it is clearly not necessary to Relevant SAEs (such as the above-mentioned fracture after falling while riding a bicycle) can be reported within 72 hours to avoid excessive use of administrative resources. Both views are supported by practical cases. You can adjust according to the requirements of your own center. The guide also includes two reporting templates corresponding to timeliness, which can be filled in directly.

In addition to such situations that are directly related to personal safety, there are also emergencies that may not seem serious, but would be a compliance red line if stepped on. Last year, something went wrong in our center: the research nurse went around for a week and mixed up the labels of the blood sample tubes of two subjects. It was only discovered during the centrifugation that someone asked not to quietly re-appoint the subjects for another blood sample? Don't be ridiculous. If you really do this and are found out by supervisors, it is data fraud, which directly concerns the center. Just follow the deviation handling process in the guide: seal the mixed samples separately as soon as possible, write down clearly the time when the deviation occurred, the people involved, and the possible scope of impact, report it to QA and ethics, then explain the situation to the subjects and retake blood, and have the subjects sign for confirmation throughout the process. In the end, except for a supplementary training for the research nurse, no problems occurred. By the way, a reminder, do not use private WeChat for all such communications, but use the work number designated by the center, otherwise you will not be able to find a place to cry when filing.

Oh, yes, there is another scene that many people did not expect: sudden public events led to the shutdown of the center. For example, during the epidemic a few years ago, many subjects were locked at home and unable to come for visits. There are no completely unified standards for this part of the treatment in the industry: some centers directly arrange remote visits, and the experimental drugs are sent to the subjects' homes via cold chain, and the entire process is videotaped to confirm taking the medicine.； Some centers have directly suspended trials due to compliance considerations, and then notified subjects to come back after the lockdown is lifted. The guides for both methods list the corresponding supplementary informed consent templates and logistics trace requirements. You can choose according to your needs.

If you ask, are there any situations that are not covered by the guide? There must be, after all, there are always more bugs in clinical research than you expect. Last month, I met a subject who suddenly lost contact after being enrolled in the group. No one answered the phone after I called him three times. His emergency contact person was his wife, but he couldn't be contacted. I went through the checklist in the guide and finally found the person through the community committee. It turned out that he secretly went to visit relatives in other places and forgot to come back for a visit. Later, our center also specially updated the ICF template and added an authorization clause for contacting the community after losing contact, which can be regarded as filling a loophole.

To put it bluntly, emergency response is like driving in an unexpected situation. The first reaction is to apply the brakes to save others, rather than first read the traffic regulations. However, after applying the brakes, you should report to insurance and determine the responsibility. You must not run away. This guide comes with a root cause analysis template at the end. Fill it out every time you deal with an emergency. After half a year, you will be able to put together an exclusive manual suitable for your center, which is better than any external experience. By the way, the pdf is an editable version, and all the templates in it can be modified according to the SOP of your own center, so there is no need to copy them rigidly.