Part 2: Guidelines for Good Clinical Practice
Part 3: Other federal regulations?
Part IV: Summary of main points?
Good clinical practice (GCP) is an international ethical and scientific standard for biomedical and behavioral research involving human participants. The purpose of this guide is to provide a unified standard for the European Union (EU), Japan, the United States, Canada and Switzerland, so as to promote the mutual acceptance of clinical trial data by regulators.
Good clinical practice (GCP) is an international moral and scientific standard for biomedical and behavioral research involving human participants. The purpose of this guide is to provide uniform standards for the European Union (EU), Japan, the United States, Canada and Switzerland, so as to promote the mutual acceptance of clinical trial data by regulators.
The current system of good clinical practice has developed, partly because of the revelation of severe abuse of research participants in the past. The exposure of these events has provided a great impetus for the formulation of laws and ethics to protect human research participants.
At present, the development of a good clinical practice system is partly to deal with the serious abuse of past research participants. The exposure of these events has provided a great impetus for the formulation of laws and ethics to protect human research participants.
This kind of training is very important for all staff involved in clinical research and ensures that they understand the principles adopted in the research.
This kind of training is very important for all staff involved in clinical research and ensures that they understand the principles adopted in the research.
? GCP is widely accepted and expected in all studies involving human participants.
? GCP is not specific to a certain protocol, but universal and applicable to all protocols.
? GCP is widely accepted and expected in all studies involving human participants.
? GCP is not specific to a certain protocol, but universal and applicable to all protocols.
Anyone directly involved in the design or implementation, supervision or management of research involving human participants, including research site staff, support personnel, contractors, subcontractors and consultants who perform key research functions, should complete GCP training. Non-researchers who provide standard care or other services unrelated to research in research centers should be encouraged to complete GCP training, but they are not required to do so.
Any person directly involved in designing or conducting, supervising or managing research involving human participants, including research site staff, reserve personnel, contractors and subcontractors? Consultants who perform key research functions should complete GCP training. Non-researchers who provide standard nursing or other non-research related services at the research site should be encouraged? Complete GCP training, but they are not required to complete it.
This course is self-paced and takes about 4-6 hours to complete. The staff of the National Institutes of Health need to complete this course every three years to ensure that all researchers understand the development of GCP, such as changes in federal regulations on protecting vulnerable research participants, electronic data or privacy protection. Encourage others to consult and follow the guidelines of their institutions, regulators and other oversight committees on recertification requirements.
The course will take about 4-6 hours to complete. NIH affiliates must complete courses every three years to ensure that all researchers keep up with the development of GCP, such as the protection of vulnerable research participants, electronic data or privacy protection in federal regulations? Small change. We encourage others to consult and abide by the recertification of their systems, oversight and other oversight committees? Requirements.
Good clinical practice (GCP) guidelines were developed jointly with the International Committee for Standardization (ICH). GCP Guide integrates many of the same principles stipulated in the early medical ethics guidelines, and provides a framework for conducting research involving human participants fairly and scientifically. The ICH GCP (R 1) guide is dated 10,1June 1996, published in the Federal Gazette of the United States on 1997, and revised to R2 version on1KLOC-0/September 9, 2065. These guidelines apply to all research involving human research participants.
Good clinical practice (GCP) guidelines were developed jointly with the International Coordinating Committee (ICH). GCP guidelines integrate many of the same principles stipulated in early medical ethics and provide a framework for fair, scientific and reasonable research involving human participants. ICHGCP (R1) published in June 1996 was published in the Federal Register of the United States in June, and was revised to R2 on June 20th165438+1October 9th. These guidelines apply to all research involving human research participants.
The purpose of the ICH GCP guide is twofold:
Ensure that the rights, safety and confidentiality of clinical trial participants are protected.
? Ensure that the data collected in clinical trials and the reported clinical trial results are accurate and credible.
The purpose of the ICH GCP guide is twofold:
Ensure that the rights, safety and confidentiality of clinical trial participants are protected.
? Ensure that the data collected in clinical trials and the reported clinical trial results are accurate and credible.
The principles in this guide can be applied to all clinical studies involving human participants, such as clinical studies involving research products, marketed drugs, medical devices or behavioral interventions.
The principles in this guide can be applied to all clinical studies involving human participants, such as clinical studies involving research products, marketed drugs, medical devices or behavioral interventions.
Federal Regulations (CFR) is the compilation (systematic arrangement) of regulations published in the Federal Register by the executive departments and agencies of the US government. The principles of good clinical practice (GCP) are codified in several chapters or titles of CFR. Failure to comply with these regulations may lead to suspension of research and fines and penalties.
The Code of Federal Regulations (CFR) is a compilation of laws and regulations (systematic arrangement) published by the administrative departments and agencies of the United States government in the Federal Gazette. The principles of good clinical practice (GCP) are compiled into several chapters or titles of CFR. Failure to comply with these regulations may lead to suspension of research and fines.
Researchers and clinicians participating in clinical trials need to be familiar with at least the following chapters of CFR, which are directly related to research involving human participants:
Researchers and clinicians participating in clinical trials should be familiar with at least the following chapters of CFR, which are directly related to research involving human participants:
[2 1 CFR 1 1] This section specifies the processing of electronic data and electronic signatures when using electronic data acquisition system. It is enforced by the US Food and Drug Administration (FDA). For more information about 2 1 CFR 1 1, please click here.
2 1 CFR 1 1 This section specifies the processing of electronic data and electronic signatures when using electronic data acquisition system. It is enforced by the US Food and Drug Administration (FDA). For more information about 2 1 CFR 1 1, please click here.
[2 1 CFR 50] This section, implemented by the US Food and Drug Administration, specifies the informed consent procedure, and lists the elements of informed consent, exceptions to general requirements and other relevant information. (See related materials in the informed consent module. ) For more information about 2 1 CFR 50, please click here.
2 1 CFR 50 This section is enforced by FDA, and specifies the informed consent procedure, elements of informed consent, exceptions to general requirements and other relevant information. (See related materials of informed consent module) For more information about 2 1 CFR 50, please click here.
[2 1 CFR 54]？ This section is enforced by FDA to manage the conflict of interest of researchers. For more information about 2 1 CFR 54, click here.
2 1 CFR 54 This section is enforced by FDA to regulate the conflict of interest of investigators. For more information about 2 1 CFR 54, click here.
[2 1 CFR 56] This section is enforced by FDA, and specifies the membership, responsibilities and operation of IRB. (See the relevant materials of the Institutional Review Committee module. ) For more information about 2 1 CFR 56, please click here.
2 1 CFR 56 This section is enforced by FDA, and specifies the members, responsibilities and operations of IRB. (See related materials in the Institutional Review Committee module) For more information about 2 1 CFR 56, please click here.
[2 1 CFR 3 12] This section is enforced by the US Food and Drug Administration (FDA) to regulate the research behavior involving the use of experimental new drugs. (See related materials of experimental new drug module. ) For more information about 2 1 CFR 3 12, please click here.
2 1 CFR 3 12 This section is enforced by the FDA, and specifies the research behavior involving the use of experimental new drugs. For more information about 2 1 CFR 3 12, please click here.
[2 1 CFR 3 14] This section is enforced by the FDA and specifies the application procedures for new drug approval. For more information about 2 1 CFR 3 14, please click here.
2 1 CFR 3 14 This section is enforced by the FDA and specifies the application procedures for new drug approval. For more information about 2 1 CFR 3 14, please click here.
[42 CFR 2 and 42 CFR 2a] These are confidentiality regulations and fall under the jurisdiction of DHHS Department of Health and Human Services. Section 2 deals with the confidentiality of records of patients with alcohol and drug abuse. Section 2a deals with the protection of research participants' identity entities. (See related materials in the Confidentiality and Privacy module. ) For more information about 42 CFR 2 and 42 CFR 2a, click? Here you are.
42 CFR 2 and 42 CFR 2a These are confidentiality regulations under the jurisdiction of the Department of Health and Human Services (DHHS). Section 2 deals with the confidentiality of records of alcoholics and drug addicts. Section 2a deals with protecting the identity of research participants. (Please refer to related materials in the Confidentiality and Privacy module) For more information about 42 CFR 2 and 42 CFR 2a, please click here.
[45 CFR 46] This regulation also regulates the membership, functions and operation of the Institutional Review Board (IRB). In addition, it includes general requirements for informed consent and codifies additional protection for vulnerable participants. Subpart A of this regulation is also called general rules. It was recently revised and will take effect on 20 18. Subparts b, c and d include provisions for pregnant women, children and prisoners in the study. It is implemented by DHHS Human Research and Protection Office. For more information about 45 CFR 46, please click here.
45 CFR 46 These Regulations also apply to the membership, functions and operation of the Institutional Review Board (IRB). In addition, it also includes the general requirements of informed consent, and formulated additional protection measures for vulnerable participants. Subpart A of this regulation is also called general rules. It was recently revised, and 20 18 came into effect. Parts B, C and D include the provisions on pregnant women, children and prisoners in the study. The project is implemented by DHHS Human Research and Protection Office. For more information about 45 CFR 46, please click here.
[45 CFR 160 and 45 CFR 164] These are the privacy rules of the Health Insurance Portability and Liability Act (HIPAA), which are enforced by the DHHS Civil Rights Office.
45 CFR 160 and 45 CFR 164 These are the privacy rules of the Health Insurance Portability and Liability Act (HIPAA), which are enforced by the DHHS Civil Rights Office.
Research involving the use of controlled substances must comply with the regulations of the Drug Enforcement Administration of the United States (2 1 CFR 1300).
Research involving the use of controlled substances must comply with the provisions of the United States Drug Administration (DEA) (2 1 CFR 1300).
In addition to the Commissioner's Office, the Food and Drug Administration (FDA) also supervises scientific activities in four areas. These areas include medical products and tobacco, food and veterinary drugs, global regulatory operations and policies, and operations. Scientific research involving drugs is subject to FDA regulations. In addition to regulating the use of new research drugs (2 1 CFR 3 12) and the listing of drugs (2 1 CFR 3 14) mentioned in Part 3 of this module, FDA regulations are also applicable to Good Manufacturing Practices (GMP), such as:
In addition to the Director's Office (OC), the Food and Drug Administration (FDA) also supervises scientific activities in four areas. These areas include medical products and tobacco, food and veterinary, global regulation and policy, and operations. Scientific research involving drugs is subject to FDA regulations. In addition to regulating the use of experimental new drugs (2 1 CFR 3 12) and the listing of drugs (2 1 CFR 3 14) mentioned in Part 3 of this chapter, FDA regulations are also applicable to good manufacturing practice (GMP), such as:
[2 1 CFR 2 10] Current good manufacturing practices for drug production, processing, packaging or preservation; ?
2 1 CFR 2 10 current good manufacturing practices for manufacturing, processing, packaging or storing drugs;
[21cfr211] good manufacturing practice.
2 1 CFR 2 1 1 current good manufacturing practice.
Another federal law is the Health Insurance Portability and Accountability Act (HIPAA) privacy rules and HIPAA security rules, which protect the privacy of research participants and their personal health information. (HIPAA is discussed in more detail in Confidentiality and Responsibility. Privacy module, part 8).
Another federal law is the Health Insurance Portability and Accountability Act (HIPAA) privacy rules and HIPAA security rules to protect the privacy of research participants and their personal health information. (HIPAA will be discussed in detail in Part 8 of the Privacy and Privacy module).
The policy of NIH regulates grant management. For more information about the NIH funding policy, please visit the website? Here you are.
The policies of the National Institutes of Health regulate the management of grants. For more information about NIH subsidy policy, please refer to the website.
Countries, states, cities and institutions can implement additional policies to protect human participants. These policies may impose stricter requirements than federal regulations. Where stricter policies have been promulgated to protect local human participants, researchers must always ensure that their research is designed and conducted in a way that meets local and federal requirements.
Countries, states, cities and institutions can implement additional policies to protect human participants. These policies may impose stricter requirements than federal regulations. If stricter policies are formulated to protect local human participants, researchers must always ensure that the design and implementation of their research meet local and federal requirements.
I good clinical practice (GCP) is an international ethical and scientific standard for the design, implementation, execution, monitoring, auditing, recording, analysis and reporting of clinical trials. This standard guarantees that:
I subjects' rights, safety, health and confidentiality are protected.
Two. The data collected in clinical trials and the reported clinical trial results are reliable and accurate.
1 Good Clinical Practice (GCP) is an international ethical and scientific standard for clinical trial design, implementation, execution, monitoring, auditing, recording, analysis and reporting. This standard guarantees that:
(1) The rights, safety, welfare and confidentiality of the subjects are protected.
(2) The data collected in clinical trials and the results of clinical trial reports are credible and accurate.
Ⅱ. The current system of good clinical practice has developed, partly because of the revelation of severe abuse of research participants in the past.
2. At present, the development of good clinical practice system is to deal with the serious abuse of research participants in the past to some extent.
ⅲ. Good clinical practice guidelines provide a framework for fair and scientific research involving human participants. Therefore, all trials should be conducted in accordance with good clinical practice (GCP), and all researchers should be trained in GCP and keep the status quo.
3. Good clinical practice guidelines provide a framework for fair, scientific and reasonable research involving human participants. Therefore, all trials should be conducted in accordance with good clinical practice (GCP), and all researchers should be trained and keep GCP up to date.
Ⅳ. All key personnel who submit applications for competitive or non-competitive projects involving human research participants to the National Institutes of Health must be trained to protect human research participants.
4. All key personnel who submit applications for competitive or non-competitive projects involving human research participants to the National Institutes of Health must receive training to protect human research participants.
5. The Code of Federal Regulations is the compilation (systematic arrangement) of laws and regulations published in the Federal Gazette by the administrative departments and agencies of the United States government. The principles of good clinical practice are codified in several chapters or titles of CFR. Failure to comply with these regulations may lead to suspension of research and fines and penalties.
5. The Compilation of Federal Regulations (CFR) is a compilation of laws and regulations (systematic arrangement) published by the administrative departments and agencies of the United States government in the Federal Gazette. The principles of good clinical practice are coded in several chapters or titles of CFR. Failure to comply with these regulations may lead to suspension of research and fines.
ⅵ. Countries, states, cities and institutions can implement additional policies to protect human participants. These policies may impose stricter requirements than federal regulations. Where stricter policies have been promulgated to protect local human participants, researchers must always ensure that their research is designed and conducted in a way that meets local and federal requirements.
6. Countries, states, cities and institutions can implement additional policies to protect human participants. These policies may impose stricter requirements than federal regulations. If stricter policies are formulated to protect local human participants, researchers must always ensure that the design and implementation of their research meet local and federal requirements.