Discuss the difference between an adverse event and an important adverse event

Recording and Reporting of Serious Adverse Events (SAEs) Serious adverse events refer to serious events that occur in the course of clinical trials, regardless of whether they are related to the trial drug: Death Life-threatening reactions Incapacity or disability Prolonged hospital stay Teratogenicity Once a serious undesirable event occurs, a special serious adverse event reporting form should be filled in in accordance with national regulations, and reported to the local State Food and Drug Administration, the reporting unit within 24 hours. Ethics Committee, and the Hospital's Medical Administrative Leadership Department. Corresponding rescue measures should be taken immediately for serious adverse events, and serious adverse events, their rescue process and outcome should be recorded in detail in the serious adverse events column of the CRF. Analyze the correlation between the serious adverse event and the investigational drug, and write a written summary report of the serious adverse event and submit it to the local State Food and Drug Administration and the above relevant parties.

An adverse event (AE) is any unexpected symptom, sign, laboratory finding, or other adverse medical occurrence after an investigational drug, whether or not related to the drug. Serious adverse events (SAEs) specifically refer to the need for hospitalization**, prolonged hospital stay, disability, impairment of work ability, congenital malformations, or even life-threatening or death. The main difference is in this "serious".

monitor-w, shine005 colleagues, you may be mistaken, I am talking about important adverse events and not serious adverse events, there is a difference between the two! Thank you for participating in this topic.

It's usually related to the primary or secondary endpoints. For example, if the trial needs to monitor hepatotoxicity, a three-fold increase in liver function is likely to be treated as an important adverse event. Specifically, depending on the requirements of the program, there are also such as severe vision loss after taking the drug, which is compared with the baseline If the subject's vision falls from to Shenma, look at the program requirements Sometimes this definition will be required by the regulatory authorities, and some are required by the sponsor.

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I would like to ask a friend who has used the IVRS system to dispense medicines, have you specifically looked for a company that stores and dispenses drugs when you do experiments? I've heard Cong Boren say that the drugs in international multi-center clinical trials are generally stored by specialized companies and distributed to various sites. Do you know about this type of company?

Can you recommend a few? View the original post

Adverse event: is an adverse medical event that occurs after a patient or a participant in a clinical trial receives a drug, but does not necessarily have a causal relationship with **. According to the requirements of the GCP, regardless of whether there is a causal relationship with the investigational drug, the investigator should record all adverse events in the original record and copy them into the case report form.

Adverse events also included an increase in the number and severity of disease that was present prior to the start of the study. Serious adverse events: Events such as hospitalization**, prolonged hospitalization, disability, impact on work ability, life-threatening or death, and congenital malformations occur during the clinical trial.

Significant adverse event: refers to any adverse event other than a serious adverse event that results in the use of targeted medical measures (e.g., discontinuation, dose reduction, and symptomatic**) and significant abnormalities in haematology or other laboratory tests.

The bai*** of the drug, also called the paradu

Reaction refers to the DAO that occurs when the drug is taken at a normal dose.

Specialized has no other related roles. These effects are also part of its pharmacological effects, such as atropine, which has an antispasmodic effect on the muscle tissue of the gastrointestinal tract and also has the effect of dilating the pupil. When patients take atropine** gastrointestinal pain, it is easy to have blurred vision***.

Adverse drug reactions include the first (side reactions) of drugs, as well as the toxic effects (toxic reactions) of drugs; Adverse effects are only a subset of adverse drug reactions. Under normal circumstances, the degree of drug is mild, and if someone has a high degree of disease, it is necessary to consider using other drugs. Patients taking a certain drug for the first time, generally starting from a lower dose, after taking it carefully pay attention to the efficacy, whether there is ***; If the efficacy is not obvious, the dose can be increased appropriately, but the maximum dose can not be exceeded.

After increasing the dose, it is necessary to closely observe whether there are adverse reactions.

Bad drug copying should generally refer to the period of taking the drug.

Some adverse reactions due to different human characteristics will have detailed instructions on the instructions.

Adverse drug events:

1.There is a problem with the quality of the drug itself, which causes harm to the human body after taking it.

2.The patient has an allergic reaction to the drug due to physical characteristics and causes injury.

3.There is no clear group of people who use the drug or who is contraindicated, resulting in adverse reactions after patients take it.

4.The dosage of the drug is not clearly labeled, resulting in the adverse consequences of overdose by the patient.

Self-check the name of the enterprise: (seal).

Self-inspection of the nature of the enterprise: production enterprises, operating enterprises, medical institutions

Item: Number Self-check content Self-check result Remarks.

1. The person in charge of the enterprise is familiar with the "Administrative Measures for the Monitoring and Re-evaluation of Adverse Events of Medical Devices (Trial)".

2 The establishment of a medical device adverse event monitoring institution by the enterprise Yes or no

3. The company has sent people to participate in the training of the "Management Measures for the Monitoring and Re-evaluation of Adverse Events of Medical Devices (Trial)".

4. The enterprise has organized internal training on the "Administrative Measures for the Monitoring and Re-evaluation of Adverse Events of Medical Devices (Trial)".

5 "The company shall establish a practical and feasible medical device adverse event monitoring system, which mainly includes: 1. The responsible department for the monitoring of medical device adverse events;

2. Training and assessment system for employees of "Management Measures for Monitoring and Re-evaluation of Adverse Events of Medical Devices (Trial)";

3. Procedures for monitoring and reporting adverse events of medical devices. "Yes No

6. Enterprises shall establish adverse event files or ** for medical devices according to their own actual conditions. Yes No

7. Collect and keep the laws, regulations, rules and regulations related to the monitoring and re-evaluation of adverse events of medical devices, as well as the relevant provisions of the food and drug supervision and administration department on adverse events of medical devices. Yes No

Self-check date: YYYYYYYYYYYYYYYYYYYYYYYY

Serious adverse event: defined as an unanticipated clinical event occurring at any dose: death; life-threatening; Need for hospitalization** or prolongation of current hospitalization**; Result in persistent or significant loss of function, or result in congenital malformations or birth defects.

Significant adverse event: refers to any adverse event other than a serious adverse event that results in the use of targeted medical measures (e.g., discontinuation of medication, dose reduction, and addition of other important **) and significant abnormalities in haematology or other laboratory tests.

In the domestic GCP, there is no definition of this important adverse event.

In ICH GCP, you can learn the definition of E1-E2F. To correct the notion that clinical presentations, abnormalities in clinical symptoms, abnormalities in laboratory test results, and other adverse events reported spontaneously by the participants, severity and drug relevance should be determined. Your definition itself is confusing, so you should jump out, understand it, and then go back to the question itself and write an answer to deal with the expert who asked the question.

Generally, the sponsor will focus on observing and monitoring the corresponding events based on the safety knowledge accumulated in the early stage, and set a pre-defined area of concern in the plan.

Don't be fooled by the self-compiled personalized terms in the domestic summary report, which are all personal opinions invented by experts themselves and cannot be widely used.

Adverse event (AE): An unforeseen medical event that occurred at the time the participant received the drug** or the study, but there was not necessarily a causal relationship with the drug used. Events can be symptoms, signs, and laboratory abnormalities.

Adverse drug reaction (ADR).

When an adverse event is evaluated and is reasonably related to the drug being studied, it is called an adverse effect of the drug.

The key difference between the two is whether it is related to the investigational drug.

Serious adverseevents are medical events that occur at any dose that are difficult to manage, whether or not related to **. Including the following situations: 1Death; 2.life-threatening;

3.resulting in the patient's hospitalization or prolongation of hospitalization; 4.Causes permanent or significant disability and functional impairment;

5.Causes congenital anomalies of teratogenesis; , affect the ability to work, or cause congenital malformations; 6.Other.

Official noun explanation:

An adverse event can be any unexpected or uncomfortable symptom, sign, disease, or event that may cause physical harm, temporarily associated with, the drug or medical device, but not necessarily causally related to the drug or medical device.

Adverse reactions refer to the occurrence of harmful reactions unrelated to the purpose of the drug in the process of drug prevention, diagnosis or disease according to normal usage and dosage. Its specific occurrence conditions are to use drugs in normal doses and normal usage, and the content excludes reactions caused by drug abuse, overdose and misuse, non-compliance with the prescribed methods and quality problems.

To put it simply, adverse events include adverse reactions and have a large scope. An adverse event is any discomfort that occurs during a clinical trial. For example, the patient has a car accident, a broken bone, an unexpected operation, etc.

Not necessarily related to the trial. The adverse reaction is that after the use of the test drug, there is a reaction unrelated to **, and the investigator judges that it must be related to the drug. For example, if the subject has nausea and vomiting after taking the drug for abdominal pain, the researcher thinks that it must be related to the drug, which is an adverse reaction and an adverse event.

I have a question in mind, first of all, the relationship between the two diagnoses of peptic ulcer and gastrointestinal tumor. Ulcers should be a symptomatic diagnosis, while tumors are a symptomatic diagnosis. There is a good chance that the ulcer is just one of the symptoms of this tumor.

If this is the case, then in fact, whether it is an ulcer or a tumor, SAE is actually a thing. According to the principle of medical diagnosis, if one diagnosis can be explained, there is no need for multiple diagnoses. Therefore, if this is the case, I think it is necessary to issue a correction report to modify the diagnosis of peptic ulcer to such and such a tumor (in the case of a pathological section of Shentong as the confirmed diagnosis).

If the tumor has not been diagnosed, it is necessary to wait for confirmation before making a correction report. If this tumor has nothing to do with this ulcer in terms of ** or symptoms. There are two cases, one is that if the hospitalization is prolonged due to the tumor, then it is a new SAE

Second, if the hospitalization is not prolonged because of this. Then, the tumor should not belong to SAEsBecause according to several situations of SAE, first of all, it leads to hospitalization, if the tumor has nothing to do with the ulcer, then the hospitalization is not valid, because the patient's hospitalization is not due to the tumor, if it is said that it is life-threatening or death, this is not in line, you can say that the tumor is not cured well, and in the end, cachexia may die of multi-organ failure, but it is by no means immediately life-threatening, so it is not compliant.

Other permanent disability, congenital diseases, etc., are also not eligible. Even if there is a special provision in the plan, I personally believe that it should be the end event, not SAEThe definition of SAE should be consistent around the world (personal humble opinion, table loss of eggs).

The above is purely even"Nonsense", ask an expert for correction. View the original post