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The dataset generation failed
Error code: DatasetGenerationError
Exception: ArrowTypeError
Message: ("Expected bytes, got a 'list' object", 'Conversion failed for column names and instead use “experimental with type object')
Traceback: Traceback (most recent call last):
File "/usr/local/lib/python3.12/site-packages/datasets/packaged_modules/json/json.py", line 151, in _generate_tables
pa_table = paj.read_json(
^^^^^^^^^^^^^^
File "pyarrow/_json.pyx", line 342, in pyarrow._json.read_json
File "pyarrow/error.pxi", line 155, in pyarrow.lib.pyarrow_internal_check_status
File "pyarrow/error.pxi", line 92, in pyarrow.lib.check_status
pyarrow.lib.ArrowInvalid: JSON parse error: Column() changed from object to string in row 0
During handling of the above exception, another exception occurred:
Traceback (most recent call last):
File "/usr/local/lib/python3.12/site-packages/datasets/builder.py", line 1815, in _prepare_split_single
for _, table in generator:
^^^^^^^^^
File "/usr/local/lib/python3.12/site-packages/datasets/packaged_modules/json/json.py", line 181, in _generate_tables
pa_table = pa.Table.from_pandas(df, preserve_index=False)
^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^
File "pyarrow/table.pxi", line 4795, in pyarrow.lib.Table.from_pandas
File "/usr/local/lib/python3.12/site-packages/pyarrow/pandas_compat.py", line 637, in dataframe_to_arrays
arrays = [convert_column(c, f)
^^^^^^^^^^^^^^^^^^^^
File "/usr/local/lib/python3.12/site-packages/pyarrow/pandas_compat.py", line 625, in convert_column
raise e
File "/usr/local/lib/python3.12/site-packages/pyarrow/pandas_compat.py", line 619, in convert_column
result = pa.array(col, type=type_, from_pandas=True, safe=safe)
^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^
File "pyarrow/array.pxi", line 365, in pyarrow.lib.array
File "pyarrow/array.pxi", line 91, in pyarrow.lib._ndarray_to_array
File "pyarrow/error.pxi", line 92, in pyarrow.lib.check_status
pyarrow.lib.ArrowTypeError: ("Expected bytes, got a 'list' object", 'Conversion failed for column names and instead use “experimental with type object')
The above exception was the direct cause of the following exception:
Traceback (most recent call last):
File "/src/services/worker/src/worker/job_runners/config/parquet_and_info.py", line 1455, in compute_config_parquet_and_info_response
parquet_operations = convert_to_parquet(builder)
^^^^^^^^^^^^^^^^^^^^^^^^^^^
File "/src/services/worker/src/worker/job_runners/config/parquet_and_info.py", line 1054, in convert_to_parquet
builder.download_and_prepare(
File "/usr/local/lib/python3.12/site-packages/datasets/builder.py", line 894, in download_and_prepare
self._download_and_prepare(
File "/usr/local/lib/python3.12/site-packages/datasets/builder.py", line 970, in _download_and_prepare
self._prepare_split(split_generator, **prepare_split_kwargs)
File "/usr/local/lib/python3.12/site-packages/datasets/builder.py", line 1702, in _prepare_split
for job_id, done, content in self._prepare_split_single(
^^^^^^^^^^^^^^^^^^^^^^^^^^^
File "/usr/local/lib/python3.12/site-packages/datasets/builder.py", line 1858, in _prepare_split_single
raise DatasetGenerationError("An error occurred while generating the dataset") from e
datasets.exceptions.DatasetGenerationError: An error occurred while generating the datasetNeed help to make the dataset viewer work? Make sure to review how to configure the dataset viewer, and open a discussion for direct support.
term
string | definition
string | sources
list | source
null | sheet
null | type
null | file
null | text
null |
|---|---|---|---|---|---|---|---|
names and instead use “Experimental
|
Drug X” or similar titles. This would not be acceptable in an actual record. 3 1-09-09
|
[
"FDAAA_CommonErrors.pdf"
] | null | null | null | null | null |
Language and Formatting Tips
|
• Spell out term when first used, acronym in parentheses • Use precise language – Do not use “proportion” unless providing a ratio – Do not use “rate” unless providing a quantity in relation to another unit (e.g., participants per unit time) – If simply reporting the number of participants, use “number” for
|
[
"FDAAA_CommonErrors.pdf"
] | null | null | null | null | null |
Measure Type
|
• In general, spell out symbols such as – “Percentage” rather than “%” – “Number” rather than “No.” or “#” • Use decimal points (not commas) for the “decimal separator” and commas (not periods) for the “thousands
|
[
"FDAAA_CommonErrors.pdf"
] | null | null | null | null | null |
Helpful Hints
|
• Measure Title • Specific name of scale • Spell out acronym, add acronym in parentheses • Measure Description • Construct/Domain if not clear from Measure Title • e.g., pain, quality of life • Range and direction of scores (e.g., 0 is best; 10 is worst) • Optional: Type of scale • e.g., continuous, ordinal • Unit of Measure • Use “participants,” if applicable (i.e., for categorical data) • Use “units on a scale” or “scores on a scale,” if no other
|
[
"FDAAA_Helpful_Hints_ResultsExamples.pdf",
"FDAAA_CommonErrors.pdf"
] | null | null | null | null | null |
about these values
|
(e.g., is “0” better or
|
[
"FDAAA_CommonErrors.pdf"
] | null | null | null | null | null |
provide thresholds when possible
|
– Especially for 2 categories (i.e., dichotomous measures) 22
|
[
"FDAAA_CommonErrors.pdf"
] | null | null | null | null | null |
represent change over time
|
– Best to report both possible outcomes (e.g., “improved” and “not improved”) – Explain the derivation of data in Measure Description • Provide time period of assessment
|
[
"FDAAA_CommonErrors.pdf"
] | null | null | null | null | null |
e.g., baseline & 6 weeks
|
• E.g., How was it determined who was “improved” and “not
|
[
"FDAAA_CommonErrors.pdf"
] | null | null | null | null | null |
Measure Description
|
Nasal secretions to Virus A/12 and B/14. Antibody
|
[
"FDAAA_CommonErrors.pdf"
] | null | null | null | null | null |
Mean ± Standard Error
|
3.22 ± 0.06 3.07 ± 0.07
|
[
"FDAAA_CommonErrors.pdf"
] | null | null | null | null | null |
DRAFT
|
33 33 • Data can be reported as continuous (e.g., median survival) or as categorical (e.g., 5-year survival) • If data collection is incomplete, a possible approach: – At a minimum, report number who reached the “event” – Report time of last measurement (use the Outcome
|
[
"SDTM.pdf",
"FDAAA_CommonErrors.pdf"
] | null | null | null | null | null |
Measure Time Frame data element)
|
• E.g., Median length of follow up with range – Report preferred descriptive statistic for those who achieved the “event” (e.g., median time to event) • Do not use a statistic that cannot be computed (e.g., if median cannot be computed, report a different percentile or
|
[
"FDAAA_CommonErrors.pdf"
] | null | null | null | null | null |
Mean ± Standard Deviation
|
9.3 ± 1.2 7.8 ± 2.1
|
[
"FDAAA_Helpful_Hints_ResultsExamples.pdf",
"FDAAA_CommonErrors.pdf"
] | null | null | null | null | null |
Percentage of Participants with ADHD
|
[units: participants] 0.257 0.062 Is this 0.257 percent or 25.7 percent?
|
[
"FDAAA_CommonErrors.pdf"
] | null | null | null | null | null |
Information
|
• Outcome Measure Title, Description – Name and description of measure must be informative to people not familiar with study – If categorized, need description of categories – Use neutral words in Title (e.g., “treatment
|
[
"FDAAA_CommonErrors.pdf"
] | null | null | null | null | null |
Use of Community Health Resources
|
[units: Number] 4.4% 10.5% • Data are inconsistent:
|
[
"FDAAA_CommonErrors.pdf"
] | null | null | null | null | null |
Indicates 4 participants
|
(of 90 or 4.4%) in the “Early Discharge” group
|
[
"FDAAA_CommonErrors.pdf"
] | null | null | null | null | null |
Yes
|
Secondary Outcome Measure: Assessment of Safety of 10 Dose 1. Name should be shorter than Description. 2. Inconsistent information in Name (e.g., “Severe Toxicity and Disease Progression”) and Description (“Disease Progression” only). Clarify how “disease progression” is measured.
|
[
"FDAAA_CommonErrors.pdf"
] | null | null | null | null | null |
Overall Response Rate
|
0.21 95% Confidence Interval 0.12 to 0.33
|
[
"FDAAA_CommonErrors.pdf"
] | null | null | null | null | null |
categories were “collapsed” into 2
|
(i.e., Which of 5 response categories
|
[
"FDAAA_CommonErrors.pdf"
] | null | null | null | null | null |
Groups
|
Drug X, Week 10 vs. Drug X, Change from Week 10 to 18
|
[
"FDAAA_CommonErrors.pdf"
] | null | null | null | null | null |
na
|
4.684 95% Confidence Interval 2.080 to 7.730
|
[
"FDAAA_CommonErrors.pdf"
] | null | null | null | null | null |
without an Estimation Parameter
|
(e.g., mean difference, hazard ratio)
|
[
"FDAAA_CommonErrors.pdf"
] | null | null | null | null | null |
Data and Method of Estimation
|
• Reported Mean Difference: “9” • By Inspection: 9.3 – 7.8 = 1.5
|
[
"FDAAA_CommonErrors.pdf"
] | null | null | null | null | null |
Number of Participants Analyzed
|
125 120 Visual Analogue Scale (VAS) Pain Assessment at 1.5 Hours [units: scores on a scale]
|
[
"FDAAA_CommonErrors.pdf"
] | null | null | null | null | null |
Least Squares Mean ± Standard Error
|
0.57 ± 0.08 1.12 ± 0.10 Statistical Analysis 1 for Visual Analogue Scale (VAS) Pain Score at 1.5 Hours 58
|
[
"FDAAA_CommonErrors.pdf"
] | null | null | null | null | null |
reported Outcome Measure
|
Additional details about the analysis, such as null hypothesis and power calculation: [1] [2] [1] Effect onset is defined as half the time between initial assessment time indicating statistical significance and the previous assessment time. Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a
|
[
"FDAAA_CommonErrors.pdf"
] | null | null | null | null | null |
priori threshold of significance:
|
[2] 2-sided statistical tests at 0.05 significance level [3] 1-09-09
|
[
"FDAAA_CommonErrors.pdf"
] | null | null | null | null | null |
Events table
|
– Note that a single type of Adverse Event Term (e.g., “asthma”) may appear in both the Serious and Other tables • If possible indicate the level of severity to distinguish “serious” from “other” adverse events (e.g., “asthma – mild and moderate” in the Other table; “asthma – severe” in the Serious table) • If no adverse events occurred, enter “0” for the Total
|
[
"FDAAA_CommonErrors.pdf"
] | null | null | null | null | null |
DRAFT – Helpful Hints: Basic Results
|
9-28-09 4 3. STATISTICAL ANALYSES Statistical analyses are tied to a specific Outcome Measure. The system allows for the entry of p-values and/or confidence intervals. There is no limit to the number of analyses that can be entered for a given Outcome Measure (e.g., four statistical analyses are associated with the Primary Outcome Measure on pp. 7-9). If a pvalue is entered, the test used must be specified. Similarly, if a confidence interval is entered, the estimated parameter must be specified. Users are encouraged to use the free text boxes to provide more complete explanations of their analyses. 4. ADVERSE EVENTS The Adverse Event module is optional (until Sept 27, 2009). However, if one chooses to use the module, the required data elements must be provided (e.g., pp. 10-11). There are separate tables for Serious Adverse Events, and for Other Adverse Events (based on frequency). The same event(s) involving the same participants should not be listed in both tables. DRAFT – Parallel Design Example – Public Display 9-28-09
|
[
"FDAAA_Helpful_Hints_ResultsExamples.pdf"
] | null | null | null | null | null |
i. Categorical Measures
|
Most categorical measures will use the number of participants as the unit. (However, it is possible that a different unit, such as the number of knees examined, can be used.) The user can define the number of categories (two or more), and should use the data entry screens to fully characterize the categories and the measures that will be entered. Sometimes a dichotomous category is presented with only one of the two categories displayed (e.g., number improved). It is preferable to report both categories explicitly (e.g., number improved and number not improved). Note that it is possible to have a categorical measure with continuous data in each cell, such as mean blood pressure and standard deviation [SD] of participants in each of three baseline diagnostic categories (e.g., “Diastolic Blood Pressure” and “Systolic Blood Pressure” baseline measures on p. 14). In this situation, the unit of measurement will typically not be number of participants, but will be whatever units are used for the measurement (e.g., mm Hg for blood pressure).
|
[
"FDAAA_Helpful_Hints_ResultsExamples.pdf"
] | null | null | null | null | null |
ii. Continuous Measures
|
Continuous measures require a measure of central tendency (e.g., mean) and a measure of dispersion/uncertainty (e.g., standard deviation). These are selected from the pull down menus that are provided in the results section of the PRS. Note that confidence interval and standard error are measures of dispersion/uncertainty for Outcome Measures, but not for Baseline Measures.
|
[
"FDAAA_Helpful_Hints_ResultsExamples.pdf"
] | null | null | null | null | null |
iii. Time to Event Measures
|
At this time, time to event measures must be represented as either categorical measures (e.g., 5 year survival) or continuous measures (e.g., mean time to death) (e.g., “Time to Disease Progression” Outcome Measure on p. 7). If desired, a series of categories can be defined to represent time points on a survival curve. 2
|
[
"FDAAA_Helpful_Hints_ResultsExamples.pdf"
] | null | null | null | null | null |
Scales
|
Outcomes may be evaluated and reported with a specific scale. In order for the measure and the outcome to be easily understood, users should describe the scale in the Outcome Measure Title, Description, and Units of Measure fields (e.g., “Mean score on the National Library of Medicine (NLM) Pain Scale” Outcome Measure below). Specific items to describe include the following: Outcome Measure Title: Name of scale (e.g., mean score on NLM Pain
|
[
"FDAAA_Helpful_Hints_ResultsExamples.pdf"
] | null | null | null | null | null |
Scale)
|
Outcome Measure Description: o What the scale measures (e.g., severity of pain) o Range and direction (e.g., 0 is no pain and 20 is severe pain) o Other information as appropriate (e.g., whether the scale is ordinal or continuous). Units of Measure: expressed as “units on a scale,” “scores on a scale,” or “points on a scale” 3
|
[
"FDAAA_Helpful_Hints_ResultsExamples.pdf"
] | null | null | null | null | null |
Parallel Design Example
|
This study has been completed.
|
[
"FDAAA_Helpful_Hints_ResultsExamples.pdf"
] | null | null | null | null | null |
prior to group assignment
|
267 participants recruited; 186 screened, 56 excluded (36 did not meet inclusion criteria and 20 refused participation).
|
[
"FDAAA_Helpful_Hints_ResultsExamples.pdf"
] | null | null | null | null | null |
Description
|
Total Number of Participants All participants received the reference test (i.e. the gold standard).
|
[
"Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf",
"FDAAA_Helpful_Hints_ResultsExamples.pdf"
] | null | null | null | null | null |
Outcome Measures
|
1. Primary Outcome Measure: Maximum Observed Plasma Concentration (Cmax)
|
[
"FDAAA_Helpful_Hints_ResultsExamples.pdf"
] | null | null | null | null | null |
Time to Disease Progression
|
Measure Description Disease progression was defined as >25% loss in hearing compared to baseline.
|
[
"FDAAA_Helpful_Hints_ResultsExamples.pdf"
] | null | null | null | null | null |
Population Description
|
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. Each participant received reference and test drug and is, therefore, included in the analysis population for both the reference and test drug.
|
[
"FDAAA_Helpful_Hints_ResultsExamples.pdf"
] | null | null | null | null | null |
Log Mean ± Standard Deviation
|
4.94 ± 1.325.52 ± 1.284.78 ± 1.11 7 DRAFT – Parallel Design Example – Public Display 9-28-09 Statistical Analysis 1 for Time to Disease Progression
|
[
"FDAAA_Helpful_Hints_ResultsExamples.pdf"
] | null | null | null | null | null |
P Value [3] 0.011
|
[1] Additional details about the analysis, such as null hypothesis and power calculation: Omnibus analysis was performed. Number of observations=150; Root mean squared error (RMSE)=1.33; R squared = 0.059; Adjusted R squared=0.046 [2] Other relevant information, such as adjustments or degrees of freedom: No text entered. [3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
|
[
"FDAAA_Helpful_Hints_ResultsExamples.pdf"
] | null | null | null | null | null |
Mean Difference (Net) [4] -0.672
|
95% Confidence Interval ( -1.224 to -0.119 ) [1] Additional details about the analysis, such as null hypothesis and power calculation: No text entered. [2] Other relevant information, such as adjustments or degrees of freedom: No text entered. [3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance: Pairwise comparisons were not corrected for multiple comparisons. [4] Other relevant estimation information:
|
[
"FDAAA_Helpful_Hints_ResultsExamples.pdf"
] | null | null | null | null | null |
Mean Difference (Net) [4] 0.059
|
95% Confidence Interval ( -0.475 to 0.594 ) [1] Additional details about the analysis, such as null hypothesis and power calculation: No text entered. [2] Other relevant information, such as adjustments or degrees of freedom: No text entered. [3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance: Not corrected for multiple comparisons. [4] Other relevant estimation information: Mean difference is Drug A minus Placebo Statistical Analysis 4 for Time to Disease Progression
|
[
"FDAAA_Helpful_Hints_ResultsExamples.pdf"
] | null | null | null | null | null |
Mean Difference (Net) [4] 0.731
|
95% Confidence Interval ( 0.234 to 1.228 ) [1] Additional details about the analysis, such as null hypothesis and power calculation: No text entered. [2] Other relevant information, such as adjustments or degrees of freedom:
|
[
"FDAAA_Helpful_Hints_ResultsExamples.pdf"
] | null | null | null | null | null |
Not adjusted for multiple comparisons
|
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance: No text entered. [4] Other relevant estimation information: Mean difference is Drug B minus Placebo 9 DRAFT – Parallel Design Example – Public Display 9-28-09 2. Secondary Outcome Measure: Time to Symptom Y
|
[
"FDAAA_Helpful_Hints_ResultsExamples.pdf"
] | null | null | null | null | null |
Results not yet posted
|
Anticipated Posting Date: May 2010.
|
[
"FDAAA_Helpful_Hints_ResultsExamples.pdf"
] | null | null | null | null | null |
Time Frame
|
24 months Additional Description A validated questionnaire was used to assess adverse events every 3 months.
|
[
"FDAAA_Helpful_Hints_ResultsExamples.pdf"
] | null | null | null | null | null |
Certain Agreements:
|
Principal Investigators (PIs) are NOT employed by the organization sponsoring the study. There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI’s rights to discuss or publish trial results after the trial is completed. 28 DRAFT – Diagnostic Test Accuracy Example – Public Display 9-28-09 29
|
[
"FDAAA_Helpful_Hints_ResultsExamples.pdf"
] | null | null | null | null | null |
Limitations and Caveats
|
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data Only the most experienced technologists participated and were asked to read the test results in this study. Results may not be applicable to those centers without technologists with extensive related experience.
|
[
"FDAAA_Helpful_Hints_ResultsExamples.pdf"
] | null | null | null | null | null |
e-mail: ABC@yahoo.com
|
U.S. National Library of Medicine, Contact Help Desk U.S. National Institutes of Health, U.S. Department of Health & Human Services, USA.gov, Copyright, Privacy, Accessibility, Freedom of Information Act DRAFT – Crossover Study Example – Public Display 9-28-09 Crossover Study Example: Drug A vs. Placebo This study has been completed.
|
[
"FDAAA_Helpful_Hints_ResultsExamples.pdf"
] | null | null | null | null | null |
recruitment period and locations
|
Participants recruited from a specialty clinic at a hospital, in Fictional City, USA between October 2004 and January 2007.
|
[
"FDAAA_Helpful_Hints_ResultsExamples.pdf"
] | null | null | null | null | null |
then Drug A
|
Placebo twice daily in first intervention period and Drug A 25 mg twice daily in second intervention period (after washout period).
|
[
"FDAAA_Helpful_Hints_ResultsExamples.pdf"
] | null | null | null | null | null |
then Placebo
|
Drug A 25 mg twice daily in first intervention period and Placebo twice daily in second intervention period (after washout period). 12 DRAFT – Crossover Study Example – Public Display 9-28-09
|
[
"FDAAA_Helpful_Hints_ResultsExamples.pdf"
] | null | null | null | null | null |
Measure Name
|
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] Measure Description AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).
|
[
"FDAAA_Helpful_Hints_ResultsExamples.pdf"
] | null | null | null | null | null |
Mean ( 95% Confidence Interval )
|
-2.1 ( -4.8 to 0.2 ) -7.2 ( -9.6 to -5.1 ) Statistical Analysis 1 for Change from Baseline in Systolic Blood Pressure at 3 Months
|
[
"FDAAA_Helpful_Hints_ResultsExamples.pdf"
] | null | null | null | null | null |
P Value [3] <0.04
|
[1] Additional details about the analysis, such as null hypothesis and power calculation: 125 participants required to detect 5 mm Hg difference in diastolic BP change, with 90% power. BP parameters not considered independent; 50% covariance assumed. Alpha level of 0.05. [2] Other relevant information, such as adjustments or degrees of freedom: No text entered. [3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
|
[
"FDAAA_Helpful_Hints_ResultsExamples.pdf"
] | null | null | null | null | null |
Two-sided
|
2. Primary Outcome Measure: Change from Baseline in Systolic Blood Pressure at 3
|
[
"FDAAA_Helpful_Hints_ResultsExamples.pdf"
] | null | null | null | null | null |
Change in Systolic Blood Pressure
|
Measure Description Value at 3 months minus value at baseline.
|
[
"FDAAA_Helpful_Hints_ResultsExamples.pdf"
] | null | null | null | null | null |
P Value [3] 0.007
|
[1] Additional details about the analysis, such as null hypothesis and power calculation: 125 participants required to detect 5 mm Hg difference in systolic BP change, with 90% power. BP parameters not considered independent; 50% covariance assumed. Alpha level of 0.05. [2] Other relevant information, such as adjustments or degrees of freedom: No text entered. [3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance: Two-sided. 17 DRAFT – Crossover Study Example – Public Display 9-28-09 3. Secondary Outcome Measure: Plasma Level of Marker X
|
[
"FDAAA_Helpful_Hints_ResultsExamples.pdf"
] | null | null | null | null | null |
Anticipated Posting Date: May 2010
|
4. Secondary Outcome Measure: Change from baseline in Weight at 3 Months
|
[
"FDAAA_Helpful_Hints_ResultsExamples.pdf"
] | null | null | null | null | null |
Neutropenia‡
|
# participants affected/at risk # events 0/127 (0%) 0 1/127 (0.79%) 1 ‡ Indicates events were collected by non-systematic methods.
|
[
"FDAAA_Helpful_Hints_ResultsExamples.pdf"
] | null | null | null | null | null |
Nausea ‡
|
# participants affected/at risk # events 5/127 (3.94%) 7 10/127 (7.87%) 12 ‡ Indicates events were collected by non-systematic methods. 19 DRAFT – Crossover Study Example – Public Display 9-28-09 20
|
[
"FDAAA_Helpful_Hints_ResultsExamples.pdf"
] | null | null | null | null | null |
The agreement is:
|
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo. The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo. Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.
|
[
"FDAAA_Helpful_Hints_ResultsExamples.pdf"
] | null | null | null | null | null |
e-mail: contactme@clinicaltrialuniversity.edu
|
U.S. National Library of Medicine, Contact Help Desk U.S. National Institutes of Health, U.S. Department of Health & Human Services, USA.gov, Copyright, Privacy, Accessibility, Freedom of Information Act DRAFT – Diagnostic Test Accuracy Example – Public Display 9-28-09
|
[
"FDAAA_Helpful_Hints_ResultsExamples.pdf"
] | null | null | null | null | null |
Diagnostic Test Accuracy Example
|
This study has been completed.
|
[
"FDAAA_Helpful_Hints_ResultsExamples.pdf"
] | null | null | null | null | null |
period and locations
|
2700 participants were selected from multiple primary care sites across the country and all were healthy at baseline without symptoms of disease.
|
[
"FDAAA_Helpful_Hints_ResultsExamples.pdf"
] | null | null | null | null | null |
assignment
|
100 participants were excluded because they did not properly observe the required pre-diagnostic test routine.
|
[
"FDAAA_Helpful_Hints_ResultsExamples.pdf"
] | null | null | null | null | null |
Sensitivity [2]
|
0.84 95% Confidence Interval ( 0.80 to 0.88 ) [1] Additional details about the analysis, such as null hypothesis and power calculation: No text entered. [2] Other relevant estimation information: No text entered. Statistical Analysis 2 for Diagnostic Test Data for Disease Using Threshold C
|
[
"FDAAA_Helpful_Hints_ResultsExamples.pdf"
] | null | null | null | null | null |
Specificity [2]
|
0.94 95% Confidence Interval ( 0.89 to 0.99 ) [1] Additional details about the analysis, such as null hypothesis and power calculation: No text entered. [2] Other relevant estimation information: No text entered. Statistical Analysis 3 for Diagnostic Test Data for Disease Using Threshold C
|
[
"FDAAA_Helpful_Hints_ResultsExamples.pdf"
] | null | null | null | null | null |
Area Under the Curve [2] 0.91
|
95% Confidence Interval ( 0.89 to 0.95 ) [1] Additional details about the analysis, such as null hypothesis and power calculation: The Area Under the Curve was estimated based on the sensitivity and specificity measures for each of three thresholds (A, B, and C) [2] Other relevant estimation information: No text entered. 27 DRAFT – Diagnostic Test Accuracy Example – Public Display 9-28-09
|
[
"FDAAA_Helpful_Hints_ResultsExamples.pdf"
] | null | null | null | null | null |
nausea
|
# participants affected/at risk # events 128/2500 (5.12%) 130
|
[
"SDTM.pdf",
"FDAAA_Helpful_Hints_ResultsExamples.pdf"
] | null | null | null | null | null |
e-mail: abc@xyz.inc
|
U.S. National Library of Medicine, Contact Help Desk U.S. National Institutes of Health, U.S. Department of Health & Human Services, USA.gov, Copyright, Privacy, Accessibility, Freedom of Information Act DRAFT – Bioequivalence Study Example – Public Display 9-28-09
|
[
"FDAAA_Helpful_Hints_ResultsExamples.pdf"
] | null | null | null | null | null |
Pharmacokinetic Outcome Measures (Bioequivalence Study) Example
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This study has been completed.
|
[
"FDAAA_Helpful_Hints_ResultsExamples.pdf"
] | null | null | null | null | null |
P-Value [3]
|
0.784755 Other Estimated Parameter [Ratio of AUC (0 - ∞) values] [4] 100.73 90% Confidence Interval (97.96 to 103.36) [1] Additional details about the analysis, such as null hypothesis and power calculation:
|
[
"FDAAA_Helpful_Hints_ResultsExamples.pdf"
] | null | null | null | null | null |
No text entered
|
[2] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance: No text entered. [3] Other relevant information, such as adjustments or degrees of freedom: No text entered. [4] Other relevant estimation information: Ratio of AUC (0 - ∞) values = Test Drug 150mg/Reference Drug 150mg 34 DRAFT – Bioequivalence Study Example – Public Display 9-28-09 35 5. Primary Outcome Measure: Plasma Decay Half-Life (t1/2)
|
[
"FDAAA_Helpful_Hints_ResultsExamples.pdf"
] | null | null | null | null | null |
Plasma Decay Half-Life (t1/2)
|
Measure Description Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
|
[
"FDAAA_Helpful_Hints_ResultsExamples.pdf"
] | null | null | null | null | null |
Least Squares Mean ± Standard Deviation
|
29.99 ± 4.84 29.99 ± 4.34 U.S. National Library of Medicine, Contact Help Desk U.S. National Institutes of Health, U.S. Department of Health & Human Services, USA.gov, Copyright, Privacy, Accessibility, Freedom of Information Act
|
[
"FDAAA_Helpful_Hints_ResultsExamples.pdf"
] | null | null | null | null | null |
access control
|
Policy and procedure that defines accessibility to a physical space or electronic source of information. The policy usually includes the concept of audit trails, either paper (e.g., signature log) or electronic.
|
[
"GCDMP_Glossary.pdf",
"Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf"
] | null | null | null | null | null |
adverse drug reaction (ADR)
|
In the pre-approval clinical experience with a new medicinal product or with its new usage (particularly as the therapeutic dose[s] may not be established), all noxious and unintended responses to a medicinal product related to any dose should be considered adverse drug reactions. The phrase “responses to a medicinal product” means that a causal relationship between a medicinal product and an adverse event is at least a reasonable possibility (i.e., the relationship cannot be ruled out). Regarding marketed medicinal products, and ADR is a response to a drug which is noxious and unintended and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of diseases or for modification of physiological function (see ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting2). See also MRCT Center Clinical Research Glossary definition.
|
[
"GCDMP_Glossary.pdf",
"ICH_E6.pdf",
"ICH_E2A.pdf"
] | null | null | null | null | null |
adverse event (AE)
|
In a subject or clinical-investigation subject administered a pharmaceutical product, any untoward medical occurrence which does not necessarily have a causal relationship with the treatment. An adverse event (AE) can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product (see the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting). See also MRCT Center Clinical Research Glossary definition.
|
[
"GCDMP_Glossary.pdf",
"ICH_E6.pdf"
] | null | null | null | null | null |
analysis dataset
|
The final data set, including derived items and excluding redundant data points, which is used to perform the analyses required for safety assessment, efficacy assessment, submission to regulatory authorities, or other review. Can be comprised of one or more data files.
|
[
"GCDMP_Glossary.pdf"
] | null | null | null | null | null |
analysis file
|
Same as analysis dataset in the context of the GCDMP.
|
[
"GCDMP_Glossary.pdf"
] | null | null | null | null | null |
annotated crf
|
A document that maps the names of the collected items to their corresponding database tables, variable item names, forms, visits and any other objects needed for a person to correctly analyze data collected in a clinical trial. Annotated collection documents are required so that any person can understand where variables for analysis originate.
|
[
"GCDMP_Glossary.pdf"
] | null | null | null | null | null |
applicable regulatory requirement(s)
|
Any law(s) and regulation(s) addressing the conduct of clinical trials of investigational products.
|
[
"GCDMP_Glossary.pdf",
"ICH_E6.pdf"
] | null | null | null | null | null |
Application Service provider (ASP)
|
An application service provider is a vendor who provides, manages and distributes softwarebased services to customers over a network. approval (in relation to institutional review boards) The affirmative decision of the institutional review board (IRB) that the clinical trial has been reviewed and may be conducted at the institution site within the constraints set forth by the IRB, the institution, Good Clinical Practice (GCP), and the applicable regulatory requirements.
|
[
"GCDMP_Glossary.pdf"
] | null | null | null | null | null |
audit
|
A systematic and independent examination of trial-related activities and documents to determine whether the trial-related activities being evaluated were conducted and the data were recorded, analyzed and accurately reported according to the protocol, the sponsor’s standard operating procedures (SOPs), GCP, and the applicable regulatory requirement(s).
|
[
"GCDMP_Glossary.pdf",
"ICH_E6.pdf"
] | null | null | null | null | null |
audit certificate
|
A declaration of confirmation by the auditor that an audit has taken place.
|
[
"GCDMP_Glossary.pdf",
"ICH_E6.pdf"
] | null | null | null | null | null |
audit report
|
A written evaluation by the sponsor’s auditor of the results of the audit.
|
[
"GCDMP_Glossary.pdf",
"ICH_E6.pdf",
"Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf"
] | null | null | null | null | null |
audit trail
|
Documentation that allows reconstruction of the course of events.
|
[
"guideline-computerised-systems-and-electronic-data-clinical-trials_en.pdf",
"GCDMP_Glossary.pdf",
"ICH_E6.pdf",
"Part_11_Electronic_Records.pdf"
] | null | null | null | null | null |
batch job
|
A series of processes run in an electronic system that perform specific tasks, such as data validation, query generation, external data upload, or lab reference range normalization.
|
[
"GCDMP_Glossary.pdf"
] | null | null | null | null | null |
biologics
|
A biological product (as a vaccine or blood serum) used in medicine.
|
[
"GCDMP_Glossary.pdf"
] | null | null | null | null | null |
blinding/masking
|
A procedure in which one or more parties to the trial is kept unaware of the treatment assignment(s). Single-blinding usually refers to the subject(s) being unaware, and doubleblinding usually refers to the subject(s), investigator(s), monitor, and, in some cases, data analyst(s) being unaware of the treatment assignment(s).
|
[
"GCDMP_Glossary.pdf",
"ICH_E6.pdf"
] | null | null | null | null | null |
case report form (CRF)
|
A printed, optical, or electronic document designed to record all of the protocol-required information to be reported to the sponsor on each trial subject.
|
[
"GCDMP_Glossary.pdf",
"ICH_E6.pdf"
] | null | null | null | null | null |
CDISC
|
Acronym for the Clinical Data Interchange Standards Consortium.
|
[
"GCDMP_Glossary.pdf",
"Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf"
] | null | null | null | null | null |
central lab
|
A vendor contracted for a clinical trial that processes samples collected from subjects and provides the results of laboratory tests or other medical analyses (e.g., ECG results, pathology results) to the sponsor. Refer to the Laboratory Data Handling chapter.
|
[
"GCDMP_Glossary.pdf"
] | null | null | null | null | null |
change control
|
A procedure that defines how planned changes to any part of a computer system are handled in a manner as to maintain compliance with required functionality of that system. The procedure ensures that changes applied to the system do not unexpectedly impact the functionality of the system in question, or any other computer systems. The procedure should also define how unexpected changes to a system are prevented and managed.
|
[
"GCDMP_Glossary.pdf",
"Susanne_Prokscha_Practical_Guide_to_Clinical_Data_Management_Third_Edition-CRC_Press_2011.pdf"
] | null | null | null | null | null |
checklist
|
(ASQ) A tool used to ensure that all important steps or actions in an operation have been taken. Checklists contain items that are important or relevant to an issue or situation. Checklists are often confused with check sheets and data sheets.
|
[
"GCDMP_Glossary.pdf"
] | null | null | null | null | null |
CLIA
|
See Clinical Laboratory Improvement Amendments.
|
[
"GCDMP_Glossary.pdf"
] | null | null | null | null | null |
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