跳至主要内容

How to ensure data quality and accuracy in non-clinical data exchange?

 


Ensuring data quality and accuracy in non-clinical data exchange requires multi-party collaboration and implementation of measures. It is very important to ensure the quality and accuracy of data in non-clinical data exchange. Here are some suggestions and methods:

1. Define clear data quality standards: Before data exchange begins, participants should clarify data quality standards, including requirements for data integrity, accuracy, consistency, authenticity, and legality. These standards should be consistent with the purposes of data exchange and the requirements for data use.

2. Data quality inspection: During the data exchange process, participants should conduct data quality inspection, including inspection of data integrity, accuracy, consistency and legality. These checks can be performed manually or using automated tools.

3. Data verification and verification: After receiving the data, the receiving party should verify and verify the data to ensure that the data meets quality standards. These verifications and verifications can include inspections of data format, content, logical relationships, etc., as well as comparisons with other data sources.

4. Use standardized data processing methods: Participants should adopt standardized data processing methods to ensure the consistency and accuracy of the data processing process. This includes standardized processes and methods for data cleaning, organization, and analysis.

5. Training and personnel quality improvement: Participants should provide training and personnel quality improvement plans to ensure that staff have the necessary data processing skills and knowledge and can understand and comply with data quality standards and data processing procedures.

6. Establish a data quality monitoring and improvement mechanism: Participants should establish a data quality monitoring and improvement mechanism, regularly assess the quality and accuracy of data, and discover and solve data quality problems. This includes mechanisms for establishing data quality assessment indicators, conducting regular data quality assessments, and tracking and resolving data quality issues.

7. Establish communication mechanisms and collaboration processes: Participants should establish effective communication mechanisms and collaboration processes to ensure timely communication and resolution of data quality and data processing issues between parties. This includes measures such as holding regular meetings, establishing communication channels, and developing collaboration processes.

In short, ensuring data quality and accuracy in non-clinical data exchange requires joint efforts and collaboration from all parties, including defining clear data quality standards, conducting data quality inspections, adopting standardized data processing methods, training and personnel quality improvement, Establish data quality monitoring and improvement mechanisms as well as establish communication mechanisms and collaboration processes.

评论

此博客中的热门博文

What is preclinical testing?

In the process of  preclinical testing  of a compound or biological agent into a drug, the compound involved must go through the testing phase. First, we need to identify potential targets that can treat the disease. Then, a variety of compounds or preparations are screened out. Any compound that has shown potential as a drug for the treatment of this disease needs to be tested for toxicity before clinical testing to reduce the possibility of injury. preclinical testing What is the basis of preclinical testing? According to US Food and Drug Administration (FDA) regulations, a series of tests are required before a new drug is approved for use. In the first stage, basic research determines a hypothetical target for the treatment of a certain disease, and then screens small molecules or biological compounds to discover any substance with the potential to treat the disease. Then, a  preclinical research  phase followed, before which, as described above, the potential toxicity of the compou

Inventory of the three major in vitro pharmacokinetic research methods

  The metabolic properties of a compound are an essential factor in whether or not it can be used as a drug in the clinical setting, so pharmacokinetic studies of newly synthesized compounds are required in drug development. In vitro incubation with liver microsomes, recombinant CYP450 enzyme lines, and in vitro incubation with hepatocytes are some of the more common in vitro drug metabolism methods. 1. In vitro incubation method with liver microsomes The metabolic stability and metabolic phenotypes of candidate compounds in different species of liver microsomes are good predictors of the metabolic properties of compounds in vivo. They are practical tools for evaluating candidate compounds in the pre-development phase of drug development. Liver microsomes include rat liver microsomes, human liver microsomes, canine liver microsomes, monkey liver microsomes, and mouse liver microsomes. In in vitro incubation of the liver, microsomes are the "gold standard" for in vitro d

Enzyme Activity Assay Service

  Enzymatic assay Lance Assay Alphascreen Assay Z’-LYTE Assay Adapta Assay Kinase-Glo Assay ADP-Glo Assay Ligand Binding Assay ELISA Assay HTRF Assay Enzyme activity assays  are laboratory methods for measuring enzymatic activity. They are vital for the study of enzyme kinetics and enzyme inhibition. Enzyme units : Amounts of enzymes can either be expressed as molar amounts, as with any other chemical, or measured in terms of activity, in enzyme units. Medicilon provides various  enzyme activity assays  for  kinases , phosphatases, proteinases, deacetylase, peptidase, esterase, and other enzymes. Our line of well-characterized immunoassays and biochemical kits ensures accurate and reproducible results. Enzyme is a  large category of bio-molecules  that catalyze various biological processes including metabolic processes, cellular signaling and regulation, cell division and apoptosis. Enzymatic reactions convert substrate molecules into chemically modified molecules products with high sp