Part 2: QA and monitoring roles
Quality assurance (QA) in clinical trials consists of planned and systematic activities, which are aimed at ensuring that the trial and the generation, recording and reporting of trial data conform to the protocol, good clinical practice (GCP) guidelines and all other applicable regulatory requirements.
Quality assurance (QA) in clinical trials includes planned and systematic activities to ensure that trials are conducted in accordance with protocols, good clinical practice (GCP) guidelines and all other applicable regulatory requirements, and to generate, record and report trial data.
Research that does not follow high quality standards will produce invalid data. This is also immoral, because it may put research participants at risk. (The protection of the safety, rights and well-being of research participants is discussed in the introduction, institutional review committee, informed consent and participants' safety and adverse events module. )
Research that is not conducted according to high quality standards will produce invalid data. This is also immoral, because it may put research participants at risk. (The protection of safety, rights and welfare of study participants is discussed in the introduction, institutional review committee, informed consent form and participants' safety and adverse events module. )
The audit conducted by the US Food and Drug Administration (FDA) found that there were several problems in the research.
The audit conducted by the US Food and Drug Administration (FDA) found several common problems in the study.
High-quality data is essential to ensure the correct interpretation of the research results. Hasty or incorrect data can lead to misleading conclusions. Careful attention to quality standards also ensures the timely completion of the research. Completing high-quality research in time can bring effective new treatments to customers faster, thus bridging the gap between research and practice.
High-quality data is essential to ensure the correct interpretation of the research results. Hasty or incorrect data may lead to misleading conclusions. Careful attention to quality standards also ensures the timely completion of the research. Complete high-quality research in time, and bridge the gap between research and practice by providing effective new treatments to customers faster.
All members of the project team are responsible for quality assurance.
All members of the agreement team are responsible for quality assurance.
Although it is common to transfer the responsibilities and functions related to quality assurance and monitoring to CRO, the organizer is ultimately responsible for implementing and maintaining the quality assurance system. (ICH GCP 5. 1. 1) This responsibility includes supervising all quality assurance systems and any test-related functions performed or managed by other parties (i.e. CRO or CRO subcontractors) on behalf of the organizer (ICH GCP 5.2.2).
Although it is common to transfer the responsibilities and functions related to quality assurance and monitoring to CRO, the organizer is ultimately responsible for implementing and maintaining the quality assurance system. (ICH GCP 5. 1. 1) This responsibility includes supervising all quality assurance systems and any test-related functions performed or managed by other parties (i.e. CRO or CRO subcontractors) on behalf of the organizer (ICH GCP 5.2.2).
Investigators and every member of the programme team should do their duty to ensure that the trial is conducted according to the highest possible quality standards.
Researchers and every member of the project team should perform their duties seriously and thoroughly to ensure that the experiment is carried out according to the highest possible quality standards.
Click to view the clinical trial network (CTN)? Related content
Click to view the related contents of Clinical Trial Network (CTN).
The organizer is responsible for ensuring the integrity of the test and making a risk-based monitoring plan. As the sponsor of all the studies carried out by the network, NIDA CTN has handed over the supervision responsibility of all monitoring to the Clinical Coordination Center (CCC).
The organizer is responsible for ensuring the integrity of the test and making a risk-based monitoring plan. As the initiator of all the studies carried out by the network, NIDA CTN has handed over the supervision responsibility of all monitoring to the Clinical Coordination Center (CCC).
CCC has formulated a systematic, prioritized and risk-based (ICH GCP E6(R2) 5. 18.3) monitoring plan for each CTN study. The plan is customized for each test, and describes the strategies, methods, responsibilities and requirements for monitoring the test (ICHGPCE6 (R2)1.64). In addition, the plan provides operational guidelines to ensure the quality and completeness of data collected under the CTN Protocol. The document also ensures the consistency of CTN research in multiple research sites and schemes. The monitoring plan:
CCC has formulated a systematic, priority and risk-based (ICH GCP E6(R2) 5. 18.3) monitoring plan for each CTN study. This plan is customized for each test, and describes the strategy, methods, responsibilities and requirements of monitoring test (ICH GCP E6(R2) 1.64). In addition, the plan also provides operational guidelines to ensure the quality and completeness of data collected under the CTN Protocol. The document also ensures the consistency of CTN research in multiple locations and schemes. The monitoring plan:
Ⅰ. Emphasize the monitoring of key data and processes.
Ⅱ. Ensure the quality and integrity of clinical research of CTN.
III. Ensure the protection of human participants.
Ⅳ. Promote cooperation between treatment and researchers in CTN base.
1, emphasizing the monitoring of key data and processes.
2. Ensure the quality and integrity of CTN clinical research.
3. Ensure the protection of human participants.
4. Promote cooperation between CTN field treatment and researchers.
The chief researcher (Li) is a specific researcher role and is fully responsible for the whole research. LI convened a project team to assist in all aspects of research, development and operation. In other studies other than CTN, this role may be regarded as the main researcher.
The main researcher (Li) is a specific researcher and takes full responsibility for the whole research. Li convened a project team to assist in all aspects of research, development and operation. In other studies besides CTN, this role may be regarded as the main researcher.
The project leader (or protocol coordinator) is Li's "right-hand man" who is responsible for coordinating and carrying out daily research work. The project leader is a member of the project team and the main contact person for the whole research-related issues. Other roles and responsibilities of the protocol team usually include but are not limited to the following:
The project leader (or agreement coordinator) is Li's "right-hand man" and is responsible for coordinating and carrying out daily learning activities. The project leader is a member of the agreement team and the main contact person for the whole research problem. Other roles and responsibilities of representatives in the agreement team usually include but are not limited to the following:
I. Data management
Second, the quality assurance
Third, training
IV. Regulatory Affairs
1, data management
2, quality assurance
Step 3 cultivate
4. Regulatory affairs
Node PI (or grantee) is another CTN-specific role, which is responsible for the research performance of NIDA at his or her node. He or she conducts research at the node together with the node staff, the main field researcher and the chief researcher. Node PI is responsible for ensuring the smooth progress of research at its node, and taking appropriate measures to assist field PI and main researchers when necessary. Other responsibilities of the node PI include:
Node PI (or assignee) is another CTN-specific role, which is responsible for NIDA's research achievements at its nodes. He or she cooperates with the node staff, the site chief researcher and the chief researcher to conduct research at the node. Node PI is responsible for ensuring the smooth progress of this node's research, and taking appropriate measures to assist the on-site PI and the chief researcher when necessary. Other responsibilities of the node PI include:
I. Appoint on-site PI and research coordinator.
Second, manage the node budget and personnel.
Ⅲ. Designate a supervisor to visit the research points in the node for quality assurance.
Ⅳ. Ensure that researchers receive appropriate training to carry out research.
ⅴ. Ensure that all necessary IRB approvals are obtained for the study and all applicable laws and regulations are followed. Understand the policies of his or her institution/university and ensure that the node abides by these policies.
1. Appoint field PI and research coordinator.
2. Manage the budget and personnel of the node.
3. Assign a supervisor to the research site of this node for quality assurance.
4. Ensure that researchers receive appropriate research training.
5. Ensure that all necessary IRB approvals are obtained for this study, and all applicable laws and regulations are observed. Understand the policies of his or her institution/university and ensure that the node abides by these policies.
The monitoring plan specifies the monitoring strategy, the monitoring responsibilities of all interested parties, various monitoring methods to be used and the reasons for using these methods. It also describes the monitoring program, the types of access, the contents involved in these accesses, and the number or percentage of each type of file to be monitored. These procedures can be further defined on the basis of the scheme according to the purpose, design, scale, complexity and main result indicators of the test (ICH GCP E6(R2) 5. 18.3).
The monitoring plan specifies the monitoring strategy, the monitoring responsibilities of all interested parties, the monitoring methods to be used and the reasons for using these methods. It also describes the monitoring program, the access type, the contents involved in the access process and the number or percentage of various files that need to be monitored. These schemes can be further defined according to the purpose, design, scale, complexity and main results of the experiment (ICH GCP E6(R2) 5. 18.3).
According to the GCP guidelines, "the applicant can choose the combination of on-site monitoring, on-site monitoring and centralized (remote) monitoring, or choose centralized monitoring alone under reasonable circumstances ... The centralized monitoring process provides additional monitoring capabilities, which can supplement or reduce the degree and/or frequency of on-site monitoring and help to distinguish reliable data from potentially unreliable data without verifying all source data" (ich GCP 5./kloc- The basic principle of the selected monitoring strategy is recorded in the monitoring plan.
According to the GCP Guidelines, "the organizer can choose on-site monitoring, the combination of on-site monitoring and centralized (remote) monitoring, or under reasonable circumstances, the centralized monitoring process can provide additional monitoring capabilities, which can supplement or reduce the scope and/or frequency of on-site monitoring and help to distinguish reliable data from potentially unreliable data without verifying all source data" (ich GCP 5.18 The basic principles of the selected monitoring strategy have been recorded in the monitoring plan.
Generally speaking, on-site monitoring is needed before, during, after or after the experiment, and remote monitoring can be carried out at any given research site. In many cases, research monitors may visit each site after the first one or two participants register, and then arrange follow-up visits according to multivariate criteria, such as registration rate, amount of data to be reviewed, site performance and other considerations.
Generally speaking, on-site monitoring is needed, and remote monitoring can be carried out at any given research site before, during, after or after the experiment. In many cases, research monitors may visit each site after the first or two participants register, and then arrange follow-up visits according to multivariate criteria such as registration rate, retrospective data volume, site performance and other considerations.
The research monitor conducted on-site visits according to the procedures described in the monitoring plan and the good clinical practice (GCP) guidelines.
Research monitors conducted on-site visits according to the procedures described in the monitoring plan and good clinical practice guidelines (GCP).
Good clinical practice guidelines stipulate that the sponsor is responsible for selecting monitors and ensuring that the following standards are met (see ICH GCP 5. 18.2).
According to the good clinical practice guidelines, the organizer is responsible for selecting monitors and ensuring that they meet the following standards (see ICH GCP 5. 18.2).
ⅰ. The inspectors have been properly trained and have the scientific or clinical knowledge needed for fully monitoring the test. The qualifications of monitoring personnel shall be recorded.
Ii. The inspector is fully familiar with the research drug, protocol, written informed consent and any other written information about the experiment to be provided to the research participants, sop, GCP of the organizer and applicable regulatory requirements.
1. The guardian has received appropriate training and has the scientific or clinical knowledge needed to fully monitor the test. The qualifications of monitoring personnel shall be recorded.
2. The guardian is fully familiar with the test drug, protocol, written informed consent and any other written information about the test provided to the research participants, the SOP, GCP of the sponsor and applicable regulatory requirements.
The quality assurance/research supervisor performs the following research activities:
The Quality Assurance/Research Supervisor performs the following research activities:
I. Conduct initial, mid-term and closing visits.
Ⅱ. Conduct centralized monitoring as appropriate.
Iii. Provide training on specific problems of the protocol and good clinical practice when necessary or appropriate.
Ⅳ. Follow up the problems found in the early supervision visit.
ⅴ. Submit reports to the organizers and other applicable parties as required.
1. Start, temporary and end visits.
2. Centralized monitoring (if applicable).
3, when necessary or appropriate, provide training on specific issues and good clinical practice.
4. Follow up the problems found in the early supervision visit.
5. Submit reports to the organizer and other applicable parties as required.
The monitoring responsibility is described in detail in ICH GCP 5. 18.4. Click here to view the summary.
The monitoring responsibilities are described in detail in ICH GCP 5. 18.4. Click here to view the summary.