Related Experiment Video
Updated: Mar 28, 2026
08:01
Biobank for Translational Medicine: Standard Operating Procedures for Optimal Sample Management
Published on: November 30, 2022
5.9K
Clinical Data Interchange Standards Consortium Standardization of Biobank Data: A Feasibility Study
Izumi Sato1, Yohei Kawasaki2, Kazuki Ide2
11 Department of Clinical Study and Informatics, Center for Clinical Sciences, National Center for Global Health and Medicine , Tokyo, Japan .
Biopreservation and Biobanking
|December 23, 2015
Summary
Japan
Area of Science:
- Biobanking and Data Standards
- Medical Informatics
- Clinical Data Management
Background:
- The National Center Biobank Network (NCBN) in Japan collects biological specimens and health data.
- Standardization of NCBN data formats is crucial for broader accessibility.
- International data standards facilitate data sharing and interoperability.
Purpose of the Study:
- To assess the feasibility of aligning NCBN data elements with international standards.
- To map NCBN data to the Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM).
Main Methods:
- Investigated 202 data elements collected by the NCBN.
- Mapped NCBN data items to the CDISC SDTM structure.
- Assessed the coverage of SDTM requirements by NCBN data.
Main Results:
- All 202 NCBN data elements could be mapped to the CDISC SDTM.
- NCBN data fulfilled 50%-70% of SDTM domain requirements.
- Demonstrated the possibility of standardizing biobank data using CDISC standards.
Conclusions:
- Standardization of NCBN biobank data to CDISC standards is achievable.
- Further consideration is needed for incorporating additional data items.
- Expert review is recommended to refine standardization efforts.
Related Concept Videos
01:13Bioequivalence studies: Biowaivers
388
In certain scenarios, in vitro dissolution tests can replace in vivo bioequivalence studies. This is particularly true when a drug product, though available in varying strengths, maintains proportional similarity in its active and inactive ingredients. In such cases, the need for in vivo bioequivalence studies for lower strength variants may be waived, provided dissolution tests and in vivo studies on the highest strength yield satisfactory results.Bioequivalence can be indicated through...
388
01:15Bioavailability Study Design: Healthy Subjects Versus Patients
208
Bioavailability studies are essential for evaluating a drug's therapeutic efficacy and understanding its absorption patterns under various physiological conditions. Conducting such studies on target patient populations provides more relevant data by simulating real-world disease states. However, practical challenges often necessitate the use of young, healthy adult volunteers as study subjects.Patients may exhibit altered drug absorption patterns due to the effects of the disease itself,...
208
01:16Bioequivalence Data: Statistical Interpretation
324
The statistical interpretation of bioequivalence data is a significant aspect of pharmaceutical research. Bioequivalence refers to the absence of any significant difference in the rate and extent to which the active ingredient in pharmaceutical products becomes available at the site of drug action when administered at the same molar dose under similar conditions. This helps determine if different drug products have similar absorption rates, ensuring their interchangeability.Statistical...
324
01:23Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
529
Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
529
01:11Bioavailability Study Design: Single Versus Multiple Dose Studies
335
Bioavailability studies are essential for understanding how a drug is absorbed, distributed, metabolized, and excreted in the body. These studies assess the extent and rate at which the active pharmaceutical agent becomes available at the site of action. The design of bioavailability studies can involve single-dose or multiple-dose regimens, each with distinct advantages and limitations.Single-dose studies are the preferred approach due to their simplicity and reduced drug exposure for...
335
01:12Statistical Software for Data Analysis and Clinical Trials
1.8K
Statistical software is pivotal in data analysis and clinical trials by providing tools to analyze data, draw conclusions, and make predictions. These software packages range from simple data management applications to complex analytical platforms, supporting various statistical tests, models, and simulation techniques. Their significance lies in their ability to handle vast amounts of data with precision and efficiency, enabling researchers to validate hypotheses, identify trends, and make...
1.8K