| Micro-channel |
 |
|
|
|
|
|
| |
| Clinical study of high frequency questions: how is informed consent process recorded? |
| |
| Author：中國銘鉉 企劃部 Release Time：2017-8-22 11:24:32 Number Browse：673 |
| |
The key to the GCP on August 22 is the protection of the subjects, so problems related to informed consent may be a serious problem. Now subjects without a signed informed consent to participate in the clinical research of events already very rare, but addresses the issue of informed consent, record the problem in the process of informed consent, for example, in China is still a very common problem. In other words, it is not enough to have subjects sign informed consent, and the process of informed consent must be recorded in the original medical record. The process of informed consent is not recorded in the original medical records, and is still one of the most frequently found problems in inspections and inspections at home.
There are no direct rules
Why does the process of informed consent have to be recorded on the subject's original medical records? Which rule of GCP is this?
In fact, whether it is a Chinese GCP (drug clinical trials and the quality control standard), was ICH E6 (ICH GCP), or rules of American 21 cfr50 (the protection of the rights and interests of the subjects), all have no direct regulation says the process of informed consent must be recorded on the original medical records of patients. The requirement for this point is only in the us regulations of 21cfr312.62, which are mentioned in the requirements of the researchers for the custody of clinical research data.
21cfr312.62 (b) Case History (medical records) : in the History of the subject, each subject must be recorded prior to the involvement of the clinical study, the informed consent has been obtained. Therefore, we can understand that this process must be recorded in the patient's medical records. However, in the same section of the statute, it is also noted that informed consent forms have been signed and are also part of the medical history.
So, now that you can see the date signed in the informed consent form that was signed, is it necessary to record it again in the history of the patient?
Based on understanding of relevant regulations
It is based on understanding of GCP and regulations that the process of "informed consent must be recorded in the original medical records". Why is there such a requirement? We can find the answer from relevant regulations and guiding principles.
1, ICH GCP
The ICH GCP 4.8.10 sets out 20 content that must be in the informed consent form, but these contents do not reflect the process of obtaining informed consent.
4.8.3 the researchers shall not force subjects to participate in clinical studies. 4.8.7 rules in obtaining informed consent before, must give the participants or the legal representative of the enough time to understand the details of the study, the inquiring about problems, so as to decide whether they really want to participate in this study. The subject or his legal representative received a satisfactory answer to all the questions they raised. 4.8.11 the subject should also obtain a signed informed consent form before participating in the clinical study.
Due to the above points are all belong to the requirements of GCP, and this time may not be reflected in the main body of the informed consent, so the process of informed consent must be recorded in the original medical records of patients, otherwise it can't reflect in the same patient when talking about informed consent to the above points. While some well-designed informed consent covers the above points, it is better to record informed consent processes in the original notes.
2, 21 cfr50
21 cfr50. 20 part is related to the general requirements of informed consent, must also mentioned to participants or their legal representative enough opportunity to consider whether to participate in clinical research, let patients with and without proper induction force patients to participate in the study to minimize the possibility of participating in clinical research.
21 cfr50. 27 part is about the record of informed consent and also mentioned in (a) must give participants a signed copy of informed consent, (b) before signing the informed consent in the subjects, the subjects must be given the opportunity to read the informed consent.
Therefore, from the understanding of this regulation, the regulation also stresses the process of informed consent.
3. GCP of China
Article 14 of GCP in China also mentioned that the subject should be given sufficient time to consider whether to participate in the experiment. Article 15 mentioned: informed consent form after full and detailed explanation of the trial. These are similar to the ICH GCP and us regulations.
What is a qualified process record
Anyhow, record the process of informed consent, originally should be from an international professional clinical research company audit inspection, found that can also be found from the official visit, but the specific source has been difficult to textual research. In any case, this has gradually become the norm, as well as the standard operating procedures and inspection report templates of many companies. If the process of informed consent is not recorded, it will be an audit.
So, what is the record of a qualified informed consent process? There is no uniform standard. In general, at least to record the participants or the legal representative there's plenty of opportunity to consider whether to participate in clinical research, the process of informed consent, give patients the chance to read the informed consent, and asking questions related to the clinical research. After signing the informed consent book, give the patient a copy, etc.
|
| |
Previous article：The holder may produce, sell and sell the drugs on its own or by commission
Next article：The new health reform policy is gradually returning to rational market
|
| |
|
|
