What is a Univariate? − A discrepancy automatically created by OC during Data Entry or Batch Loading − When the data entered is not the expected data according to the specified attributes. − Data Type and Partial Date are the only types of univariates for which we can modify the question attributes to influence the…
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Oracle Clinical stores all values to questions in a table called the Responses table. The responses are stored either in Value_Text or Exception_Value_Text. − Data is stored in VALUE_TEXT if the data type, length, format and value is valid. − Data is stored in EXCEPTION_VALUE_TEXT if the data type, length, format or value is not…
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Discrete Value Group: − Set of valid responses to a question − Used when a list of choices is offered on the CRF Checkboxes on the CRF page may be drop-down inTAO − Created and assigned to a question at the Glib level − 3 types of DVGs: Internal DVGs Alpha DVGs Thesaurus DVGs
Adverse Event comparison report: To show recently added and updated (follow-ups) AEs since the last the PSUR. Highlight the PTs with a change of >= 5% from the current PSUR period compared to the previous PSUR period. PTname, Count of PTs – Current, Count of PTs – Previous, Count of PTs since the Day 1,…
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Frequency by System Organ Class: SOC, PT, Count of PTs
Provide Cumulative frequency listing for the following PTs: Renal failure LFT Abnormal Provide number of Cases for each PT, the source of that Case (clinical, Post-Marketing , etc.), and the Causality. Columns: Preferred Term, Source, Causality, Number of PTs. Renal Failure Spontaneous Related 10 Renal Failure …
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Simple clicks would show a colorful graph of Patient Profile. The best part is, scroll through the Days (visits) to see if Treatment Emergent AEs. Attachments: Sample GPP report.
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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The Periodic Safety Update Report (PSUR) is required as part of the FDA Post Marketing Drug Risk Assessment (PMDRA) program. The PSUR report is evolving with the ICH initiatives and the February 2004 FDA Guidance for industry. Sample PSUR is attached.
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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