IntroductionA required step for presenting results of clinical studies is the declaration of participants demographic and baseline characteristics as claimed by the FDAAA 801. The common workflow to accomplish this task is to export the clinical data from the used electronic data capture system and import it into statistical software like SAS software or IBM SPSS. This software requires trained users, who have to implement the analysis individually for each item. These expenditures may become an obstacle for small studies. Objective of this work is to design, implement and evaluate an open source application, called ODM Data Analysis, for the semi-automatic analysis of clinical study data.MethodsThe system requires clinical data in the CDISC Operational Data Model format. After uploading the file, its syntax and data type conformity of the collected data is validated. The completeness of the study data is determined and basic statistics, including illustrative charts for each item, are generated. Datasets from four clinical studies have been used to evaluate the application’s performance and functionality.ResultsThe system is implemented as an open source web application (available at https://odmanalysis.uni-muenster.de) and also provided as Docker image which enables an easy distribution and installation on local systems. Study data is only stored in the application as long as the calculations are performed which is compliant with data protection endeavors. Analysis times are below half an hour, even for larger studies with over 6000 subjects.DiscussionMedical experts have ensured the usefulness of this application to grant an overview of their collected study data for monitoring purposes and to generate descriptive statistics without further user interaction. The semi-automatic analysis has its limitations and cannot replace the complex analysis of statisticians, but it can be used as a starting point for their examination and reporting.

Abstract (en): Roll call voting records for both chambers of the United States Congress through the second session of the 105th Congress are presented in this data collection. Each data file in the collection contains information for one chamber of a single Congress. The units of analysis in each part are the individual members of Congress. Each record contains a member's voting action on every roll call vote taken during that Congress, along with variables that identify the member (e.g., name, party, state, district, uniform ICPSR member number, and most recent means of attaining office). In addition, the codebook provides descriptive information for each roll call, including the date of the vote, outcome in terms of nays and yeas, name of initiator, the relevant bill or resolution number, and a synopsis of the issue. ICPSR data undergo a confidentiality review and are altered when necessary to limit the risk of disclosure. ICPSR also routinely creates ready-to-go data files along with setups in the major statistical software formats as well as standard codebooks to accompany the data. In addition to these procedures, ICPSR performed the following processing steps for this data collection: Checked for undocumented or out-of-range codes.. All roll call votes in the United States Congress. 2010-05-06 Data for the 105th Congress, House, and Senate (Parts 209-210), have been added to this collection, along with the standard ICPSR full product suite of files.2004-06-17 Variables were added to Part 110, Senate (55th Congress), and data within certain variables were corrected. SAS and SPSS data definition statements and the codebook have been modified to reflect these changes.2001-08-24 Logical record length data for the 8th session of the Senate, Part 16, is being made available along with SAS and SPSS data definition statements. The codebook has been modified to reflect these changes.1998-12-17 Data for the 104th Congress, House and Senate (Parts 207-208), have been added to this collection, along with corresponding machine-readable documentation and SAS and SPSS data definition statements.1997-02-24 Data for the 102nd and 103rd Congresses, House, and Senate (Parts 203-206) have been added to this collection, along with corresponding machine-readable documentation and SAS and SPSS data definition statements. The technical format has been standardized for all Congresses. Each file contains data for one chamber of a single Congress.

Abstract (en): This data collection provides comparable measures of state appellate and trial court caseloads by type of case for the 50 states, the District of Columbia, and Puerto Rico. Court caseloads are tabulated according to generic reporting categories developed by the Court Statistics Project Committee of the Conference of State Court Administrators. These categories describe differences in the unit of count and the point of count when compiling each court's caseload. Major areas of investigation include (1) case filings in state appellate and trial courts, (2) case processing and dispositions in state appellate and trial courts, and (3) appellate opinions. Within each of these areas of state government investigation, cases are separated by main case type, including civil cases, capital punishment cases, other criminal cases, juvenile cases, and administrative agency appeals. ICPSR data undergo a confidentiality review and are altered when necessary to limit the risk of disclosure. ICPSR also routinely creates ready-to-go data files along with setups in the major statistical software formats as well as standard codebooks to accompany the data. In addition to these procedures, ICPSR performed the following processing steps for this data collection: Performed consistency checks.; Checked for undocumented or out-of-range codes.. State appellate and trial court cases in the United States. 2005-11-04 On 2005-03-14 new files were added to one or more datasets. These files included additional setup files as well as one or more of the following: SAS program, SAS transport, SPSS portable, and Stata system files. The metadata record was revised 2005-11-04 to reflect these additions.2003-08-27 Part 45, Appellate Court Data, 2001, and Part 46, Trial Court Data, 2001, have been added to the data collection, along with corresponding SAS and SPSS data definition statements and PDF codebooks.2002-08-13 Part 43, Appellate Court Data, 2000, and Part 44, Trial Court Data, 2000, have been added to the data collection, along with corresponding SAS and SPSS data definition statements and PDF codebooks.2001-10-31 Part 41, Appellate Court Data, 1999, and Part 42, Trial Court Data, 1999, have been added to the data collection, along with corresponding SAS and SPSS data definition statements and PDF codebooks.2000-03-23 Part 39, Appellate Court Data, 1998, and Part 40, Trial Court Data, 1998, have been added to the data collection, along with corresponding SAS and SPSS data definition statements and PDF codebooks.1999-07-16 Part 37, Appellate Court Data, 1997, and Part 38, Trial Court Data, 1997, have been added to the data collection, along with corresponding SAS and SPSS data definition statements and PDF codebooks. Funding insitution(s): State Justice Institute (SJI-91-N-007-001-1). United States Department of Justice. Office of Justice Programs. Bureau of Justice Statistics. The Court Statistics Project Web page is: http://www.ncsconline.org/D_Research/csp/CSP_Main_Page.html.A user guide containing court codes and variable descriptions for the 1987 data and the codebooks for the 1995-2001 data are provided as Portable Document Format (PDF) files, and the codebooks for the 1988-1992 data are available in both ASCII text and PDF versions.

Abstract (en): The purpose of this study was to provide an in-depth look at rapes and attempted rapes in the United States. Part 1 of the collection offers data on rape victims and contains variables regarding the characteristics of the crime, such as the setting, the relationship between the victim and offender, the likelihood of injury, and the reasons why rape is not reported to police. Part 2 contains data on a control group of females who were victims of no crime or of crimes other than rape. The information contained is similar to that found in Part 1. All persons in the United States. A stratified multistage cluster sample. 2005-11-04 On 2005-03-14 new files were added to one or more datasets. These files included additional setup files as well as one or more of the following: SAS program, SAS transport, SPSS portable, and Stata system files. The metadata record was revised 2005-11-04 to reflect these additions.2000-09-29 SPSS data definition statements were updated and SAS data definition statements were added to this collection. Also, the codebooks and data collection instrument are now available in two PDF files. Funding insitution(s): United States Department of Justice. Office of Justice Programs. Bureau of Justice Statistics. The codebooks and data collection instrument for this collection are provided by ICPSR as Portable Document Format (PDF) files. The PDF file format was developed by Adobe Systems Incorporated and can be accessed using PDF reader software, such as the Adobe Acrobat Reader. Information on how to obtain a copy of the Acrobat Reader is provided on the ICPSR Website.This collection of rape cases was taken from the NATIONAL CRIME SURVEY: NATIONAL SAMPLE, 1973-1983 (ICPSR 7635). The definition of rape in the survey includes attempts that involve a verbal threat of rape only. The data in Part 1 were collected at the incident level. Part 2 data were collected at the person level, with information for up to four incidents per person.

Abstract (en): This dataset presents information on the relationship between drug and alcohol use and contacts with police for persons in Racine, Wisconsin, born in 1955. The collection is part of an ongoing longitudinal study of three Racine, Wisconsin, birth cohorts: those born in 1942, 1949, and 1955. Only those born in 1955 were considered to have potential for substantial contact with drugs, and thus only the younger cohort was targeted for this collection. Data were gathered for ages 6 to 33 for the cohort members. The file contains information on the most serious offense during the juvenile and adult periods, the number of police contacts grouped by age of the cohort member, seriousness of the reason for police contact, drugs involved in the incident, the reason police gave for the person having the drugs, the reason police gave for the contact, and the neighborhood in which the juvenile was socialized. Other variables include length of residence in Racine of the cohort member, and demographic information including age, sex, and race. ICPSR data undergo a confidentiality review and are altered when necessary to limit the risk of disclosure. ICPSR also routinely creates ready-to-go data files along with setups in the major statistical software formats as well as standard codebooks to accompany the data. In addition to these procedures, ICPSR performed the following processing steps for this data collection: Checked for undocumented or out-of-range codes.. All individuals born in 1955 in Racine, Wisconsin, and those who had migrated there by the age of 6. The sample includes all individuals born in 1955 and attending school (i.e., appearing in the Racine school census records) in 1966. 2005-11-04 On 2005-03-14 new files were added to one or more datasets. These files included additional setup files as well as one or more of the following: SAS program, SAS transport, SPSS portable, and Stata system files. The metadata record was revised 2005-11-04 to reflect these additions.2001-12-21 SAS and SPSS data definition statements were added to the collection and the documentation was converted into PDF format. Funding insitution(s): United States Department of Justice. Office of Justice Programs. National Institute of Justice (87-IJ-CX-0045). (1) Other datasets that are part of this ongoing study include: JUVENILE DELINQUENCY AND ADULT CRIME, 1948-1977 [RACINE, WISCONSIN]: THREE BIRTH COHORTS (ICPSR 8163), JUVENILE DELINQUENCY AND ADULT CRIME, 1948-1977 [RACINE, WISCONSIN]: CITY ECOLOGICAL DATA (ICPSR 8164), and SANCTIONS IN THE JUSTICE SYSTEM, 1942-1977: THE EFFECTS ON OFFENDERS IN RACINE, WISCONSIN (ICPSR 8530). (2) Users should note that police contact, rather than the individual, is the unit of analysis in this collection, and that each contact is a record. Therefore, there can be multiple records (contacts) per individual. Each individual is identified by the variable UID (Unique Identification Number). (3) The codebook is provided by ICPSR as a Portable Document Format (PDF) file. The PDF file format was developed by Adobe Systems Incorporated and can be accessed using PDF reader software, such as the Adobe Acrobat Reader. Information on how to obtain a copy of the Acrobat Reader is provided on the ICPSR Web site.