The industry wide Signal detection challenge is to identify Drug Drug Interaction for a Serious Adverse Event. Well…. it is not that challenging when it is just Drug and Drug and an Event. The challenge comes if it is Drug Drug Drug Drug and Event and Lab value.
Let us discuss in details…. in the meantime,watch this interesting TED talk
Non-Interventional Study = Medicinal product is prescribed in the usual manner (Example: Acetaminophen only)
Interventional Study = Participants are assigned to receive one or more interventions so that researchers can evaluate the effects of the interventions. (Study medication (Acetaminophen ) with Cantaloupe juice and Aspirin)
Commonly used abbreviations in Pharmaceutical Industry
Academic Research Organization CDMoP
Clinical Data Monitoring Plan CRA
Contract Research Associate CRO
Contract Research Organization CSR
Clinical Study Report CTTI
Clinical Trials Transformation Initiative DM
Data Manager DMon
Data Monitoring – All raw and source data review activities by a sponsor that guarantee the protection of trial subject safety and privacy as well as provide assurance that the clinical data meet quality requirements and are fit for purpose. This includes direct (on site) review and verification but also distributed or centralized intra- and inter-site data checks in order to identify trends, signals etc. These activities are usually documented in one or more manuals or plans (such as the CDMoP, DMP, SAP, etc.) DMP
Data Management Plan DSci
Data Science –Analytical role enabling the creation of data products that tackle all aspects of a problem, from initial data collection and data conditioning to drawing conclusions across programs EMA/GCP/INS
European Medicines Agency Good Clinical Practice Inspectors Group FDA
Food and Drug Administration GCP
Good Clinical Practices GxP
Abbreviation for the basket of regulatory guidance for clinical, laboratory, and manufacturing practices
Good Pharmacovigilance Practice
Intent to Treat IVRS/IWRS
Interactive Voice/ Web Response System QA
Quality Assurance QC
Quality Checks Risk-Based Approach rSDV
Reduced Source Document Verification SDR
Source Document Review – Process of holistic review of documentation for patient data as indicated by the protocol, e.g. real subject, documents maintained, investigational product. SDV
Source Document Verification – Process of point-to-point verification of site data entry values between source and database SAP
Statistical Analysis Plan
Its a component of OBIEE (Oracle Business Intelligence Enterprise Edition) where a developer can create a layout (just the layout) for complex-layout report.
The following report has two totals at the bottom. This is simple, why to use BI publisher for it? Well, its just an example of Row-level columns. Report can have All Concomitant drugs separated by comma (,) as a row level column.
Its a reporting environment for Argus safety application. Oracle integrated the OBIEE (Oracle Business Intelligence Enterprise Edition) an Oracle report development tool with Argus application for reports creating and publishing.
Drag and drop User interface lets the User choose the column needed to build a simple report.
Complex reports (meaning the output format is busy) can be built via BI Publisher.