Khoppenworth: /* 1.8.4 Downloading a Dataset for Further Analysis */

2023-09-12T15:51:42Z

1.8.4 Downloading a Dataset for Further Analysis

← Older revision		Revision as of 15:51, 12 September 2023
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	Please note that selecting the Adverse Drug Reaction will enable the Dashboard and Patients tab.		Please note that selecting the Adverse Drug Reaction will enable the Dashboard and Patients tab.



	You are able to now view a 2 by 2 table illustrating relative risk and 95% Confidence Interval for the selected reaction.		You are able to now view a 2 by 2 table illustrating relative risk and 95% Confidence Interval for the selected reaction.
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	· 95% Confidence Interval for the associated medication		· 95% Confidence Interval for the associated medication
	=== 1.8.4 Downloading a Dataset for Further Analysis ===		=== 1.8.4 Downloading a Dataset for Further Analysis ===
	Select the '''Download Data''' tab and then click the '''Download Dataset''' button to able to download a comprehensive dataset of patient clinical data in XLSX format for importation into a third-party statistical tool.		Select the '''Download Data''' tab and then click the '''Download Dataset''' button to able to download a comprehensive dataset of patient clinical data in XLSX Excel format for importation into a third-party statistical tool.

	{\| class="wikitable"		{\| class="wikitable"
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	\|}		\|}
			The Excel file password is: rcAHtHx&pN6cE3kL

Khoppenworth: /* 1.8.4 Downloading a Dataset for Further Analysis */

2023-09-12T15:41:37Z

1.8.4 Downloading a Dataset for Further Analysis

← Older revision		Revision as of 15:41, 12 September 2023
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	= ~~5 Analytical~~ Portal =		= Analytical Portal =
	At the '''Home Page''' of the Analytical Portal''',''' you will be presented with the following options:		At the '''Home Page''' of the Analytical Portal''',''' you will be presented with the following options:

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	· '''Analyst.''' An analytics user is able to assign terminology, set causality and run analysis on collected data.		· '''Analyst.''' An analytics user is able to assign terminology, set causality and run analysis on collected data.
	\|}		\|}


	{\| class="wikitable"		{\| class="wikitable"
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			== Spontaneous Reporting ==
	~~'''1 '''~~

	== ~~1.1 Spontaneous~~ Reporting ==
	Spontaneous reports are termed spontaneous as they take place during the clinician’s normal diagnostic appraisal of a patient, when the clinician is drawing the conclusion that the drug may be implicated in the causality of the event.		Spontaneous reports are termed spontaneous as they take place during the clinician’s normal diagnostic appraisal of a patient, when the clinician is drawing the conclusion that the drug may be implicated in the causality of the event.

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	PViMS facilitates a public facing interface that allows clinicians or the public itself to spontaneously report on adverse event related data. See chapter 8 for more information.		PViMS facilitates a public facing interface that allows clinicians or the public itself to spontaneously report on adverse event related data. See chapter 8 for more information.

	== ~~1.2 Active~~ Reporting ==		== Active Reporting ==
	Active surveillance for monitoring the safety and effectiveness of medical products is increasingly recognized as a complement to spontaneous reporting commonly used by pharmacovigilance systems. Integrated mechanisms and processes for monitoring the safety of medicines are essential to a well-functioning pharmaceutical sector. A positive benefit-to-risk balance should precede access to market; however, most regulatory decisions take place early in the product lifecycle and are based on limited data from clinical trials that may be of relatively short duration with limited numbers and types of subjects.		Active surveillance for monitoring the safety and effectiveness of medical products is increasingly recognized as a complement to spontaneous reporting commonly used by pharmacovigilance systems. Integrated mechanisms and processes for monitoring the safety of medicines are essential to a well-functioning pharmaceutical sector. A positive benefit-to-risk balance should precede access to market; however, most regulatory decisions take place early in the product lifecycle and are based on limited data from clinical trials that may be of relatively short duration with limited numbers and types of subjects.

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	Active surveillance is particularly important to support the introduction of new essential medicines in LMICs whose regulatory systems are being developed and are in need of support. In resource-limited settings, active surveillance can help determine the real-life frequency, risk factors, and impact of clinically significant adverse medicine events on treatment outcomes.		Active surveillance is particularly important to support the introduction of new essential medicines in LMICs whose regulatory systems are being developed and are in need of support. In resource-limited settings, active surveillance can help determine the real-life frequency, risk factors, and impact of clinically significant adverse medicine events on treatment outcomes.

	== ~~1.3 Pharmacovigilance~~ Activities ==		== Pharmacovigilance Activities ==
	{\| class="wikitable"		{\| class="wikitable"
	\|This section describes the common processes adopted by the pharmacovigilance unit in responding to both spontaneous and active reports submitted through PViMS.		\|This section describes the common processes adopted by the pharmacovigilance unit in responding to both spontaneous and active reports submitted through PViMS.
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	· Generate a patient summary		· Generate a patient summary
	\|}		\|}
	~~'''1 '''~~

	~~1.1 ''' '''~~

	~~1.2 ''' '''~~		==== Terminology ====

	~~1.3 ''' '''~~

	=== ~~1.3.1~~ Terminology ===
	'''Causality Assessment Scale or Terms.''' The assessment scales or terms were developed to help standardize assessment of causality for all adverse drug reactions. The result is determined by an algorithm designed by Naranjo or WHO for determining the likelihood of whether an adverse drug event is actually due to the drug rather than the result of other factors. Probability is assigned via a score termed definite, probable, possible or doubtful (Naranjo) or certain, probable/likely, possible, unlikely, conditional, unassessable or unclassified (WHO). Values obtained from this algorithm are sometimes used in peer reviews to verify the validity of author's conclusions regarding adverse drug reactions.		'''Causality Assessment Scale or Terms.''' The assessment scales or terms were developed to help standardize assessment of causality for all adverse drug reactions. The result is determined by an algorithm designed by Naranjo or WHO for determining the likelihood of whether an adverse drug event is actually due to the drug rather than the result of other factors. Probability is assigned via a score termed definite, probable, possible or doubtful (Naranjo) or certain, probable/likely, possible, unlikely, conditional, unassessable or unclassified (WHO). Values obtained from this algorithm are sometimes used in peer reviews to verify the validity of author's conclusions regarding adverse drug reactions.


	'''MedDRA Terminology'''. MedDRA or Medical Dictionary for Regulatory Activities is a clinically validated international medical terminology dictionary by regulatory authorities in the pharmaceutical industry during the regulatory process, from pre-marketing to post-marketing activities, and for data entry, retrieval, evaluation, and presentation. In addition, it is the adverse event classification dictionary endorsed by the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).		'''MedDRA Terminology'''. MedDRA or Medical Dictionary for Regulatory Activities is a clinically validated international medical terminology dictionary by regulatory authorities in the pharmaceutical industry during the regulatory process, from pre-marketing to post-marketing activities, and for data entry, retrieval, evaluation, and presentation. In addition, it is the adverse event classification dictionary endorsed by the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).
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	'''E2B'''. The international standard for transmitting medicine adverse event reports specified by the ICH.		'''E2B'''. The international standard for transmitting medicine adverse event reports specified by the ICH.

	=== 1.3.2 Process Flow ===		==== 1.3.2 Process Flow ====
	{\| class="wikitable"		{\| class="wikitable"
	\|'''Activity: Start of Process'''		\|'''Activity: Start of Process'''
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	· The risk factors to be applied		· The risk factors to be applied



	The '''Analyser''' function can be accessed through the main menu.		The '''Analyser''' function can be accessed through the main menu.
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	==== 1.8.3.2 Specifying the Date Range for the Analysis ====		==== 1.8.3.2 Specifying the Date Range for the Analysis ====
	By selecting a '''Date Range''', the system will determine which patients should be included into the analysis from the Patient Population specified in the previous step. Patients that have been actively exposed to medication within that range will be included.		By selecting a '''Date Range''', the system will determine which patients should be included into the analysis from the Patient Population specified in the previous step. Patients that have been actively exposed to medication within that range will be included.


	==== 1.8.3.3 Specifying Risk Factors for the Analysis ====		==== 1.8.3.3 Specifying Risk Factors for the Analysis ====


	To specify a '''Risk Factor,''' click the Risk factor field and select the risk factor you would like to include into the analysis. Once you have selected the risk factor, select the appropriate option associated to that risk factor and click the '''add''' icon to add the risk factor to the selected list.		To specify a '''Risk Factor,''' click the Risk factor field and select the risk factor you would like to include into the analysis. Once you have selected the risk factor, select the appropriate option associated to that risk factor and click the '''add''' icon to add the risk factor to the selected list.


	You are able to add as many risk factors as you would like to include into the analysis by repeating the above process.		You are able to add as many risk factors as you would like to include into the analysis by repeating the above process.


	By including '''Risk Factors''' into the analysis, the system will determine which patients match the criteria stipulated by the set of risk factors and the corresponding '''Relative Risk Ratio''' will be adjusted based on the new population set.		By including '''Risk Factors''' into the analysis, the system will determine which patients match the criteria stipulated by the set of risk factors and the corresponding '''Relative Risk Ratio''' will be adjusted based on the new population set.
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	Please note that selecting the Adverse Drug Reaction will enable the Dashboard and Patients tab.		Please note that selecting the Adverse Drug Reaction will enable the Dashboard and Patients tab.



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	· Incidence Rate for exposed group		· Incidence Rate for exposed group



	· Incidence Rate for non-exposed group		· Incidence Rate for non-exposed group



	· Relative Risk for the associated medication		· Relative Risk for the associated medication

	· 95% Confidence Interval for the associated medication		· 95% Confidence Interval for the associated medication


	=== 1.8.4 Downloading a Dataset for Further Analysis ===		=== 1.8.4 Downloading a Dataset for Further Analysis ===
	Select the '''Download Data''' tab and then click the '''Download Dataset''' button to able to download a comprehensive dataset of patient clinical data in XLSX format for importation into a third-party statistical tool.		Select the '''Download Data''' tab and then click the '''Download Dataset''' button to able to download a comprehensive dataset of patient clinical data in XLSX format for importation into a third-party statistical tool.

	{\| class="wikitable"		{\| class="wikitable"
	\|		\|

Khoppenworth: Created page with "= 5 Analytical Portal = At the '''Home Page''' of the Analytical Portal''',''' you will be presented with the following options: ● Spontaneous and Active Reports ● Spontaneous and Active Analyzer {| class="wikitable" |The analytical portal is the centralized hub for causative drug assessment using traditional recognized rating scales, standardized terminology, and risk detection with exposed versus non-exposed risk ratios. '''Note''': t..."

2023-08-14T19:14:56Z

Created page with "= 5 Analytical Portal = At the '''Home Page''' of the Analytical Portal''',''' you will be presented with the following options: ● Spontaneous and Active Reports ● Spontaneous and Active Analyzer {| class="wikitable" |The analytical portal is the centralized hub for causative drug assessment using traditional recognized rating scales, standardized terminology, and risk detection with exposed versus non-exposed risk ratios. '''Note''': t..."

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OpenRIMS-PVM - User Manual Chapter 5 - Revision history

Khoppenworth: /* 1.8.4 Downloading a Dataset for Further Analysis */

Khoppenworth: /* 1.8.4 Downloading a Dataset for Further Analysis */