What is the difference between safety database and clinical database?
What is the difference between safety database and clinical database?
Actually this is a bit complicated since the clinical research database usually holds both serious adverse events (SAEs) and also non-serious adverse events (NSAEs). The safety database usually only holds, from clinical trials, SAEs only (or a few NSAEs which happen to accompany the SAEs in each case).
What is database lock in clinical trials?
The process of locking a clinical trial database is an action taken to prevent further changes to the database. Once the database is complete and clean the database is locked to prevent further changes to the data and the analysis may be performed.
What is safety database in pharmacovigilance?
A pharmacovigilance safety database is the central repository for individual case safety reports or ‘ICSRs collected for a company’s medicinal product(s) from all sources globally.
What is a clinical database?
Clinical databases consist of observational data collected on patients who meet specific criteria. Single institution databases frequently are used to profile patient accrual. In cases of rare diseases or unusual procedures, multicenter databases are required to amass sufficient information for study.
Why SAE reconciliation is required?
An SAE-Reconciliation meeting is often necessary to discuss the discrepancies and determine if they are acceptable or decide on the appropriate course of action.
What does it mean to reconcile data?
Data reconciliation (DR) is a term typically used to describe a verification phase during a data migration where the target data is compared against original source data to ensure that the migration architecture has transferred the data correctly.
What is a lock in a database?
A database lock is used to “lock” some data in a database so that only one database user/session may update that particular data. So, database locks exist to prevent two or more database users from updating the same exact piece of data at the same exact time.
What are the types of lock in database?
At the table level, there are five different types of locks:
- Exclusive (X)
- Shared (S)
- Intent exclusive (IX)
- Intent shared (IS)
- Shared with intent exclusive (SIX)
What is safety reconciliation?
The process of comparing key safety data variables between the drug or device safety SAE database and the clinical database in order to identify any discrepancy, determine whether a discrepancy is acceptable or not and, if acceptable, document the discrepancy.
What is Argus safety System?
Oracle Argus is a comprehensive pharmacovigilance platform which enables pharmaceutical companies and clinical trial organizations to make faster and better safety decisions, optimize global compliance, and easily integrate risk management.
What is an example of clinical data?
The data collected includes administrative and demographic information, diagnosis, treatment, prescription drugs, laboratory tests, physiologic monitoring data, hospitalization, patient insurance, etc. Individual organizations such as hospitals or health systems may provide access to internal staff.
When would you use clinical data?
Clinical data is used by public and private payers for cost-effectiveness research and assistance with optimal reimbursement decisions; healthcare organizations store increasing quantities of clinical data for internal applications realizing that this data could soon become a very valuable asset.
Why is clinical database locked in clinical trial?
The data validation is done by data managers (DM) who query the Site personnel or investigator in case of any discrepancy found. This overall process is called data management. Why Clinical Database is locked? During a clinical trial, a lot of effort goes into data management before “final database is lock” or the “hard lock” happens.
Is the clinical research database the same as the safety database?
Actually this is a bit complicated since the clinical research database usually holds both serious adverse events (SAEs) and also non-serious adverse events (NSAEs). The safety database usually only holds, from clinical trials, SAEs only (or a few NSAEs which happen to accompany the SAEs in each case).
How is clinical data stored in a database?
Historically, the most common mechanism for long-term clinical data storage has been to extract the final data from the clinical data management system into SAS® datasets.
Are there other databases that hold safety data?
The problem arises when there are other databases that hold safety data. Fundamentally any database that is used to collect safety data, where the data is ultimately going to be submitted to a health authority (FDA, EMA etc.), must be secure and validated.