0
What is reconciliation and safety data reconciliation in clinical data management?
Wiki User
∙ 15y ago
What happens, once patient experiences any serious adverse event at investigational site then the investigator is suppose to fill SAE form and send it to the drug safety department of the company, and there the drug safety department will enter that SAE form in their safety database. At the same time investigator have to mention that serious adverse event in the CRF of that patient and then send it to the clinical data management dept. CDM role is to merge or reconciliate the safety database and clinical database of that particular patient in the oracle clinical dabase system.
Wiki User
∙ 15y ago
Reconciliation in clinical data management refers to comparing data from different sources to ensure consistency and accuracy. Safety data reconciliation specifically involves comparing safety data between different databases, such as adverse event reports and laboratory data, to identify discrepancies or inconsistencies. This process helps ensure data integrity and patient safety in clinical trials.
Add your answer:
Earn +20 pts
Where can one find information about enterprise data management?
You can find information about enterprise data management from sources such as industry publications, conferences, webinars, online courses, professional associations (e.g., DAMA International), and consulting firms specializing in data management. Additionally, resources like research reports, whitepapers, and case studies from reputable organizations can provide valuable insights into best practices and trends in enterprise data management.
What is the fullform of DBMS?
The full form of DBMS is Database Management System.
What is Storing data in one place is called?
Storing data in one place is called centralization. This can help streamline data management, increase efficiency, and improve data consistency.
What are the documents and procedure used in an AIS to collect and process transaction data?
Documents used in an AIS to collect transaction data include invoices, receipts, and purchase orders. The process involves data collection, data input, data processing, information storage, and data output in the form of reports and financial statements. Procedures such as data validation, reconciliation, and internal controls are put in place to ensure the accuracy and reliability of the processed data.
What is the meaning of the term data domain?
A data domain refers to a specific category or field within a dataset that represents a particular aspect of the data. It helps organize data into logical groupings for easier management and analysis. Examples of data domains include customer information, financial data, and product details.
What has the author Susanne Prokscha written?
Susanne Prokscha has written: 'Practical guide to clinical data management' -- subject(s): Clinical Pharmacology, Clinical trials, Data Collection, Data base management systems, Data processing, Database management, Drugs, Information management, Methods, Organization & administration, Testing
What companies offer clinical data management?
There are many companies all over the world that offer clinical data management. These vary from the very large corporations such as IBM, to SGS and QAS.
What software can be used to store clinical data?
A clinical data management software system (CDMS) is used to store clinical data. It is specially designed software built to reduce the possibility of incorrect data entry due to human error.
What industries use a clinical trial management system?
The clinical trial management system is used in biochemical, pharmecutical industries and clinical research institutions. The system itself is used to correlate large amounts of data concerning the clinical trial.
When are researchers specifically required by NIH policy to describe Data and Safety Monitoring?
For all clinical trials
What is data cleaning in clinical data management?
Data cleaning is where the data may have missing data such as gender and the data manager has to go back to the source to find the data or data is incorrect and has to be corrected back at the source.
What are the duties of clinical trial data management?
The duties of the clinical trial date management is to keep track of everything that takes place during a clinic trial. This ranges from how the patient feels and all their symptoms to documenting concerns.
What has the author Alison Cornish written?
Alison Cornish has written: 'A web-based clinical data management system for serious adverse events data'
What does DCRP stand for?
DCRP stands for Decentralized Clinical Research Platform. It is a platform that leverages blockchain technology to provide secure and transparent data management for clinical research studies.
What services do eClinical Solutions offer?
Some of the services that eClinical Solutions offer include clinical reporting, data standardization, electronic data capture, and end to end data management.
What is batch validation in clinical data management?
batch validation is a programmed validation to achieve valid data. its done after data entry and before data cleaning. batch validation can be over night process or day process.
What does a clinical data manager do?
The job of a clinical data manager is to ensure that statistical data and results from clinical trials gets recorded accurately. The clinical data manager must record information about the effects of medication on patients, as well as experimental data and any issues with a study.
