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 ACRO 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…
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JReview and SpotFire Comparison: Feature Jreview Spotfire Graphic Patient Profile End-User can create on the fly. Require IT Support help Patient Review Tracking Keep track of patients reviewed. Not Available. Tabular Patient Profile Spreadsheet-view with ‘New Data’ hightlights Not Available. Formated Patient Profile PDF-view. Similar SAS output. Can be scheduled as Batch-run Not Available. Patient…
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Oh Oh! that’s what you hear from the folks who does the Serious Adverse Event Reconciliation. Fight (and politics) between the DM and PV never could reconcile. So does the SAE Reconciliation. Hospitalization but Resolved. – DM said Nooo, it wasn’t. Onset of Renal Failure is after Prior Dose. – PV denied. Six categories of…
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Food and Drug Administration is not a Cop. Its your Mom! FDA wants to make sure you are doing the right thing. To keep the FDA in loop, you have to keep tweeting your status periodically viz. Periodic Safety Update Report (PSUR), Developmental Safety Update Report (DSUR), SUSAR, Council for International Organizations of Medical Sciences (CIOMS), Serious Adverse-event Report,…
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