1) Careful and rigorous, with the ability to deal with emergencies;

2) Good medical professional knowledge, familiarity with GCP and CET-6, and the ability to learn and master new knowledge quickly;

3) Good efficient communication skills, independent working ability and team spirit.

Excellent CRA should be added to the above:

1) sincerely love clinical research and continue to work hard for it;

2) Excellent enterprises (top 500 or excellent CRO) have more than 3 years CRA working experience and have completed more than 2 clinical trials;

3) Have a solid and rich medical background and continue to pursue advanced studies in this field.

2) How to screen hospitals?

My understanding is how to judge whether the site in the base is suitable for clinical trials. )

Mainly refers to four factors:

1) Whether the main researchers or researchers in the center have relevant qualifications and experience (including familiarity with clinical drugs and GCP training, etc.);

2) Whether there is enough time to complete the test on schedule;

3) Whether there are enough pathogens to complete enrollment on time;

4) Whether there are enough test equipment and instruments.

Reasonable fees, good cooperation, reliable quality and convenient travel search are conducive to smooth registration and marketing.

Abide by the duties of clinical researchers required by GCP; Have enough time to ensure the implementation of the test; I am interested in the research value of my new drug clinical trial project, and regard the trial as a serious scientific exploration activity; Be able to complete the participants' entry plan on time; Should not participate in other competitive test projects of new drugs of the same disease at the same time; Honesty and integrity, rigorous work, team guarantee.

3) What are the basic principles of 3)GCP?

My GCP principle

1 The implementation of clinical trials shall conform to the ethical principles derived from the Helsinki Declaration, GCP and applicable management requirements.

Before starting the experiment, we should weigh the foreseeable risks, inconveniences and expected benefits of individual subjects and society. Only when the expected benefits outweigh the risks can clinical trials begin and continue.

The rights, safety and health of subjects are the most important considerations, which should be higher than the interests of science and society.

The existing non-clinical and clinical data on the experimental drugs should be sufficient to support the proposed clinical trial.

Clinical trials should have a solid scientific foundation and a clear and detailed test plan.

The implementation of clinical trials should follow the experimental scheme approved/recognized by IRB)/ ICE in advance.

The duty of a qualified doctor or dentist is always to provide medical care for the subject and make medical decisions on behalf of the subject.

Everyone involved in the implementation of clinical trials should be qualified to complete his or her expected tasks in education, training and experience.

Every subject should get a freely given informed consent form before participating in clinical trials.

10 all clinical trial data should be recorded, processed and stored so as to accurately report, interpret and check the data.

1 1 The confidentiality of records that may identify objects shall be protected, and the privacy and confidentiality provisions shall be observed in accordance with applicable management requirements.

12 test drugs shall be manufactured, transported and stored in accordance with the applicable good manufacturing practice (GMP). Test drugs should be used according to the approved scheme.

13 a program system should be established to ensure the quality of all aspects of testing.

4) What measures should be taken for patients who are slow to join the group?

Regarding the progress, there are two problems: the progress is slow; The progress of each center is uneven. (Fast progress will naturally not be a problem)

1. Progress is slow

The solution to the slow progress depends on the cause of the slow progress. Some people think that slow progress means fewer patients and inspectors can't help it. In fact, we can analyze the reasons for the slow progress and some possible solutions:

1. 1 No patients.

No patients are a common saying among researchers. For our inspectors, we should pay attention to the fact that this sentence may be true or false. If it's a lie, we'll discuss it later. Let's look at the truth first. Even if it is true, it is not necessarily true to pay attention. The reason is that saying that there are fewer researchers and fewer patients does not mean that there are fewer patients in this center. Maybe the researcher you are looking for only participates in your research in his own name, that is, he is the only one collecting cases. He may be out of the patient group every day or most of the time, may have surgery, or may only see the clinic for two and a half days a week (we have seen him). At this time, you have to investigate the situation, and you can't just go to the director, the general doctor who doesn't participate in the experiment, or even the nurse to help you get the necessary information. For example, can you know whether there are really no patients, when and in which season there are more patients, and what kind of patients are mainly local or foreign? Naturally, it is not easy for outsiders to join the group. After understanding, if you think it is possible to advance the progress, you need to mobilize the enthusiasm of the whole department, even the enthusiasm of nurses (in fact, it is easy), and the work will go on. By doing this, progress will come up.

Another reason is that the researcher's persuasion ability is poor or he himself doesn't approve of drugs or research. For example, he thinks that research is to experiment with patients. The truth is that it is not that there are no patients, but that patients are unwilling to join the group. At this time, you need to do a lot of persuasion work. For centers with few clinical trials, it is essential to pay attention to early training, which must reflect the characteristics of research drugs (each drug has its own characteristics). If you can't do this, you can only impress researchers in other ways. At the same time, as an inspector, I must agree with the research and have confidence. In fact, many of our domestic clinical studies are drugs that have been listed abroad, and many cases belong to regional and ethnic confirmatory studies. The other is to compensate patients and promote patients to join the group. Be cautious about this method. I'm not talking about paying. If a student-dominated group thinks it is possible to promote joining the group, I might as well give it a try, but be cautious in other cases. Because it makes sense that China people don't give money, once they give money, patients will think that you are lying to him, which leads China people to suspect that there is definitely nothing good in it. But it doesn't mean not to give it. You can consider some small gifts, even some printed materials about this kind of disease, popular science knowledge such as diet and life (this is sometimes a good idea, so try it).

Let's consider the real situation: there are no patients, and there are even fewer patients in this center (this department, not just this researcher). There are deeper reasons, such as the academic strength of this center is not strong, the beds in the ward are not enough, and the number of outpatient visits is small; There is also the peak season. Many diseases are seasonal. Although it is not typical, it actually has a great influence on the research. Like the clinical practice of antibiotics, respiratory tract infections are easy to enter the group in autumn and winter. Another example is seasonal allergic rhinitis. This should be considered before the project is implemented. Make arrangements in advance, don't rush to get the front stage ready, and then rush hard, wasting energy. Even holidays should be taken into account, such as the traditional festival in China: Spring Festival. As a project manager, you should spare at least one month. If your data entry is for students or your statistician is for students, then you should take both winter and summer vacations into account, if the budget is the entry work that needs to be done to complete the case observation at that time. Of course, in addition to the above, there are other factors that affect the absence of patients, such as moving in the hospital (don't think this situation is rare, someone may have encountered it) and ward decoration. All these factors, in addition to preparing in advance, have to find another way. Adding a center is one way, but it needs re-filing and ethical review (see the regulations of leading hospitals, sometimes it only needs to be filed, because adding a center is not the main factor of ethical review).

Job advertisement. Recruitment advertisements can be divided into in-hospital and out-of-hospital (I named them myself, hehe). In fact, outside the hospital refers to the media, and the general cost is more cost-effective, such as newspapers. As the name suggests, the hospital can be expanded. As for how to expand, I'll sell it here and leave a room for thinking.

1.2 robbing patients (no lies about patients)

Robbing patients is the most common situation in reality, and it is also the most troublesome situation. First of all, a center has multiple drugs for the same indication at the same time. Compared with antibiotics, cephalosporins, quinolones and aminoglycosides have been developed in recent years, all of which are aimed at the same patient group: respiratory tract infection and urinary tract infection. If one is a pill and the other is an injection, it will be easy. Because the tablets are mostly patients with mild infection. If a few of them are injections, the problem will be big. In addition, several manufacturers produce the same medicine in the same center. Although this situation is not allowed by the state, it still exists. Because there are too many approved manufacturers, such as pazufloxacin. If this situation is found in the preparatory stage of the project, it needs to be considered: Do you need to change the base? Can the clinical department control it? How to control it? Is the source of patients mainly inpatient or outpatient? Are there enough beds? To paraphrase a sentence: "early detection, early prevention and early treatment", hehe (there are not many ways! )。 If it is discovered during the project, it must be clear that CRA is essentially a service. Monitoring is an end, not a method. The same species should put pressure on the clinic because it is not allowed by relevant laws and regulations. Different varieties, but not more than three for the same indication. Whether you can change it or not, you have to do a good job in service and get the recognition of your work from researchers. There are not many methods, but this is the core.

2. Progress is uneven. That is, some centers are fast and some centers are slow.

Transfer the case. This situation appears in the randomized design of central blocks, but not in the randomized design of large centers (that is, each center randomly has no fixed number of cases, but arranges random numbers and drugs by telephone, which is rarely done at present). The transferred cases have the following problems:

How many cases have been handed over?

How many cases does the slow moving center guarantee to be statistically significant?

How to turn?

Generally speaking, the block is random, so the number of transferred cases is also transferred between the centers in the block. The purpose is to ensure that the trial-control ratio of each center after transfer is 1: 1. There is no fixed statement on how much transfer is appropriate. However, the number of cases in each center should not be too small, which will lose the significance of multi-center clinical practice. Note: The significance of multi-center clinical practice lies in ensuring the diversity of sample sources. As for the minimum number of effective cases in the sub-center, what is the statistical significance? Note: Each center is not required to be statistically significant. At present, it is no longer required to write a sub-center summary report (but a sub-center statistical report is required). The centers with few cases can only make a statistical description. But we can't have more than 40 cases in one center and only 4 cases in another center.

Another point to note is that statistical significance is not equal to clinical significance. No statistical significance does not mean no clinical significance. The key depends on how to explain it, how to design the scheme and the characteristics of the disease.

Remember one thing: the purpose of multi-center is to ensure the diversity of sample sources. We can't transfer the case to a multi-center clinic, which loses the significance of multi-center.

5) Document requirements for starting clinical trials?

Document requirements for starting clinical trials (I think this question can be used to answer "What are the main documents for clinical trials"):

1) certification (SFDA certification, IEC certification)

2) Test documents (test plan, ICF, recruitment advertisement and project plan, CRF, IB and all relevant revisions and supplements that have passed the ethics).

3) Sign contracts (researcher contracts, financial regulations)

4) medication list (receiving list and distribution record of experimental drugs, etc.). )

5) Laboratory documents (normal range, quality control certificate, etc. )

6) Resumes, registration forms and relevant documents of researchers.

7) Forms and operation specifications of the Company (audit report, audit registration form, etc.). )

6) What is the difference between adverse reactions and adverse events?

The key to the difference between the two is whether it is related to experimental drugs. Adverse events (AE): Unforeseen medical events that occurred during clinical trials, but may have no causal relationship with the drugs used. Events can be symptoms, signs, laboratory abnormalities and temporary diseases that may be related to experimental drugs. Adverse Drug Reaction (ADR): refers to the harmful reactions that have nothing to do with the purpose of drug use or are unexpected under the normal usage and dosage of qualified drugs. When an adverse event is evaluated and determined to be related to the drug being tested, it is called an adverse drug reaction.

7) How does 7)CRA help researchers retain subjects?

This has a lot to do with doctors and the government. As far as the research I am monitoring now is concerned, different sub-centers in the same area are very different. In the same city, its culture and people's values on medicine are the same, but there are great differences in compliance between the two companies. The compliance of one family is even less than 20%, and the other family has not dropped off and lost the visit. The reason is the doctor. First, whether the hospital has established a good follow-up system. Some hospitals will require patients to come back to the clinic regularly or irregularly, while others will not care whether the patients return to the clinic or not. Second, it is the medical literacy of hospital doctors themselves. If their medical level is not high, people will never look back. Third, it is the communication level of doctors and the degree of relationship with patients. On the one hand, look at the doctor's medical ethics, on the other hand, look at his communication skills. Some doctors can basically treat patients well, at least patients will not resist; But some people are gloomy all the time. It seems that everyone owes him money, which makes them unhappy, and the patient will not hang him when he leaves the hospital. Fourth, patients' cognition of regular outpatient service still needs doctors to do it, which is the popularization of basic medical awareness, and doctors are duty-bound. Five, the government (real medical insurance and real people's hospital). Sixth, the government (let the people have money and real purchasing power).

8) What are the responsibilities of researchers and inspectors?

What are the responsibilities of researchers?

1) Be familiar with the protocol, conduct clinical trials in strict accordance with the protocol, and participate in the revision of the protocol when necessary;

2) Familiar with the characteristics and usage of experimental drugs;

3) Assist the respondent to obtain IEC approval;

4) Responsible for obtaining the informed consent signed by the subjects;

5) Ensure that the test site has good conditions, including sufficient personnel and appropriate facilities;

6) There are enough pathogens to complete the enrollment of subjects on time;

7) There are enough events to complete the clinical trial on time with good quality and quantity, and submit the qualified and accurate clinical trial report (multi-center trial, the main researcher is responsible for the completion of the report). Of course, researchers must have the education, training and clinical experience needed for specific experiments.

What are the duties of auditors?

First of all, the test preparation confirms that the site has the conditions for testing:

Staffing and training, complete equipment, sufficient pathogens, researchers familiar with experimental drugs, clinical programs and related documents.

Second, the test has begun.

1) Make a visit plan.

2) Confirm that the subjects have signed ICF, and learn about the registration and exam progress.

3)SDV: Confirm that the test data and general report format are true, complete and accurate, and save the original files.

4) Confirm AE and SAE records and meet the reporting requirements.

5) Verification of experimental drugs: whether they are stored, distributed and recycled according to regulations, and make detailed records.

Three, the end of the test to recover drugs, save the test data, help to report the test data and results of monitoring purposes:

1) ensure that the trial follows the clinical protocol, GCP and relevant management regulations.

2) Protect the rights and safety of subjects.

3) The test records and reported data are true, complete and accurate, and are consistent with the original data.

9) How to manage the experimental drugs in the experiment? When will experimental drugs be allowed to be sent to the hospital?

1) Strict management: ensure that it is only used by subjects, and ensure the compliance of subjects through drug counting.

2) Person in charge: The principal investigator shall designate personnel to manage and record the receipt, distribution, storage, recovery and destruction of drugs (including positive control substances and placebos) in detail. Drugs should be stored in a safe that meets the storage conditions. In a double-blind trial, drugs should be distributed in random order.

3) Effective counting: After the test, the subjects are required to return the remaining drugs and used drug packaging boxes for counting. After obtaining the approval of SFDA and IEC, the experimental drugs can be sent to the hospital.

10) How to design the scheme? What does this plan include?

The clinical trial scheme mainly includes: the scheme is a document describing the purpose, design, method, statistics and implementation of the trial, and usually gives the experimental background and theoretical basis. In short, the plan describes in detail how to carry out the clinical trial, including the purpose and design of the trial, the selection and exclusion of patients, the evaluation index of safety and effectiveness, how to take drugs, how to analyze data and how to deal with adverse reactions.

1 1) What's the difference between a serious adventure and a serious adventure? How to report it?

Serious adverse events () refers to any dose of refractory medical events, whether related to treatment or not.

Including:

1) died;

2) Life-threatening;

3) Causing the patient to be hospitalized or prolonging the hospitalization time;

4) Causing permanent or severe disability/dysfunction;

5) Causing congenital abnormality/deformity, affecting working ability, or, causing congenital abnormality;

6) others.

Serious adverse events's report: In addition to taking immediate emergency measures for the subjects, researchers must immediately report to the organizers and IEC, and report to SFDA safety supervision department within 24 hours. Usually, the SFDA registration department also needs to report.