Table of Contents
What is line listing in clinical trials?
It summarizes how case reports were selected for inclusion in the line listings. Line listings provide key information on all SARs (blinded and unblinded) reported from the sponsor’s studies during the reporting period. The data is organized by trial and then by System Organ Class (SOC).
Where does information on a line listing come from?
The information that goes into a line list is generally collected on a questionnaire. The important elements from the questionnaire are then used to create a line list. The data obtained during a case finding can provide clues about the outbreak and potential risk factors associated with illness.
What is a line listing?
The line listing is one type of epidemiologic database, and is organized like a spreadsheet with rows and columns. Typically, each row is called a record or observation and represents one person or case of disease.
What is the importance of line listing?
A line listing allows information about time, person, and place to be organized and reviewed quickly. It is also a good way to keep track of different categories of cases. For example, cases can be entered into the line listing as possible, probable or confirmed (laboratory- confirmed, clinically confirmed or both).
What is the purpose of a line list?
Line lists can also be extracted from database systems such as Microsoft Access, Epi Info, and Epi Data. These database systems offer more features to minimize data entry error when used by well-trained personnel.
What does Susar stand for?
SAR is the abbreviation for Serious Adverse Reaction, and SUSAR for Suspected Unexpected Serious Adverse Reaction.
What is the value of line listing in epidemiology?
A line listing is a table in which important information is recorded on each person who is ill with gastroenteritis in an outbreak. This information will assist you in keeping track of sick residents and staff, enabling you to implement control measures to stop the outbreak spreading.
What is listedness in pharmacovigilance?
, Trained physician working for pharmacovigilance. Listedness is done while assessing a case in pharamcovigilance for a approved/marketed product from a labelling document i.e. SmPC or PIL or package insert.
Where can a line listing report be dynamically generated?
A line listing report can be dynamically generated from PV databases such as Clinevo Safety, Argus, ArisG, and other available safety databases. What is the salary scenario in pharmacovigilance sector?
What is a Lineline listing?
Line listing is a report which can be generated dynamically from PV databases like Oracle Argus and Clinevo Safety. They help PV professionals to identify the cases reported for a specific product or specific country or for a specific date range.
What are the short term courses in drug safety and pharmacovigilance?
Master of Science in Drug Safety and Pharmacovigilance Short Term Courses Short Term Program in Base SAS Short Term Program in Clinical Data Management and Oracle Clinical Short Term Program in Clinical Research Nursing Advanced SAS Clinical with CDISC, SDTM and ADAM