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A65 A methodology to perform the “paperless” clinical trial: Electronic signatures for electronic data
Abstracts
425
A63 COLLECTION OF ELECTRONIC CLINICAL DATA FROM UK COMMUNITY DOCTORS Alison Bourke and Shephali Parmar
VAMP Research London, England For over 3 years VAMP Research has been pioneering electronic collection of clinical trial data at source. VAMP doctors are already trained to routinely use their computers for recording patient histories. They are now entering clinical trial data directly onto their computer systems using specially tailored screens. These extra screens form the basis of the electronic clinical trial systems. These systems allow: -
Highlighting of potential trial patients Automatic checking of inclusion and exclusion criteria Integration with existing medical and therapy history records Data validation at entry Automatic drug and disease coding On-screen protocol help - Fast data aggregation and analysis Four electronic clinical research systems in separate therapeutic areas have been developed and implemented to date. Their advantages and limitations will be discussed. A64 A METHODOLOGY TO PERFORM THE "PAPERLESS" CLINICAL TRIAL: OVERVIEW AND GENERAL PRINCIPLES James Roehon and Lance R. Bailey
Robarts Research Institute Ontario, Canada Data management in randomized clinical trials is an intricate and demanding process consuming a considerable amount of the resources of the study management center. The volume of data is typically quite large; the data themselves are heterogeneous in nature and collected from sources both geographically and temporally dispersed. Distributed data enta,y (DDE) systems have long been used to respond to this challenge. Personal computers are located at each of the clinical centers and software is written to screen for eligibility at patient entry, perform range checks and consistency checks as the data are entered and invoke skip patterns to avoid irrelevant sections of the data forms. Indeed, technology has progressed to the point where an deetronic dat__~basecan replace the paper Case Report Forms (CRF's) as the "official" repository of data collected from the trial. The sole justification for retaining the paper CRF's, however, is the requirement from regulatory agencies (and others) for a signature indicating legal, medical and academic responsibility for the data recorded therein. In this paper, we propose a methodology for performing the "paperless" clinical trial. The itie issue of data accountability will be addressed, that is, assigning responsibility for every data to a particular individual. Thus, this paper will describe: (1) Procedures to ensure that only authorized individuals add, modify and delete study data; (2) Desiderata for an electronic signature extending to all data fields; and (3) Data management principles to oversee the entire process.
~e~d
A65 A METHODOLOGY TO PERFORM THE "PAPERLESS" CLINICAL TRIAL: ELECTRONIC SIGNATURES FOR ELECTRONIC DATA Lance R. Bailey and James Rochon
Robarts Research Institute Ontario, Canada Electronic data collection has been shown to be an effective way of collecting information for large trials. Unfortunately, it lacks the authenticity and responsibility of a signed piece of paper, a drawback which stops a regulated trial from being completely electronic. Automated TeBer Machines (ATM) for banking services have broken through this barrier to allow millions of dollars each day to be transferred without the need for a paper signature. The magnetic-
426
Abstracts
stripe card and Personal Identification Number (PIN) allow a person to be uniquely identified to the machine. By combining ATM technology with remainder checksum algorithms such as used in computer data communications to ensure integrity, the author demonstrates an approach to which meets the desiderata for electronic signatures by providing the following: : no CRF is transmitted unless signed by at least two persons each piece of data is bound to the signatures s no piece of data may be altered without all signing parties resigning the data received information is confirmed against a protected, central master list of authorized persons An algorithm employing a cyclic redundancy code will be followed through to demonstrate how electronic signatures can be easily incorporated into transmitted data to provide both authenticity and
integrity. A66 AN INTEGRATED CLINICAL TRIAL DATABASE INTEGRITY EVALUATION SYSTEM (DIES) Mark A. Levinson and Mitchell Hiller
The EMMES Corporation Potomac, Maryland We have developed a system of programs called the Data Integrity Evaluation System (DIES) that allows for systematic examination of clinical trial master databases for most types of errors and omissions. At the heart of the system is a comprehensive data dictionary which defines all of the attributes of each variable used in the study. Most of the edit checks performed on master databases at the coordinating center are repetitive. DIES provides a mechanism to simplify the specification of these checks, to track the status of outstanding edit checks, and to generate meaningful reports, both for internal consumption and for transmission to clinical centers for remedial action. DIES provides the Data Manager, project programmer, or Pl with tools for defining which study files are to be examined and automatically builds base d~t~ dictionary entries for the variables in these files. The dsts dictionary can be enhanced with inner and outer range limits and labels. In building the inventory of edit checks for a project, tools are provided for defining which files are logically connected and the set of edit checks to be performed on them. This can be done either interactively or through a structured specification language. Tools are also provided for reviewing detected "anonudies" and designing reports for displaying them. DIES has been developed as a project independent software system with all information relevant to a project coded into meaningful tables. These tables serve as audit trails in that they contain detailed documentation of the evaluations performed, the anomalies detected, and the status of anomaly resolution. DIES has been successfully implemented into all ongoing studies supported by The EMMES Corporation. P01 EDUCATIONAL ACTIVITIES OF THE DUTCH WORKING GROUP FOR DATA MANAGERS Mildred C. Boon*, B. van den Bos, M. Harteveld, I. Mandjes and H. Smit
*University Hospital Leiden The Netherlands One of the aims of the Dutch Working Group for Data Managers is to provide their 60 members, working mainly in oncology, with educational possibilities. It has been recognized that high quality of data collection can only be reached when properly trained personal is available. Regular activities consist of two general meetings which cover different fields, one intensive workshop or course, training options in experienced centers and three newsletters per year. In 1992 the group has received an extra grant for educational purposes. This enabled us to provide 22 members with individual support to follow a course of their own choice and to organize extra plenary activities. An earlier performed inquiry showed that 93 % of the interviewed persons indicated that studying literature was one of the main options for further education. Applicable books are spread over many different fields as: medical statistics, epidemiology, informatics and oncology. Another category which is difficult to retrieve, but could be very useful for new data managers are unofficial editions like p.roceedings of meetings, course books and other not published material. A special data managers library, with a broad collection of titles has been set up, which is available for all members. A catalogue has been made, the first books have been ordered and the library is operational from November 1992.
425
A63 COLLECTION OF ELECTRONIC CLINICAL DATA FROM UK COMMUNITY DOCTORS Alison Bourke and Shephali Parmar
VAMP Research London, England For over 3 years VAMP Research has been pioneering electronic collection of clinical trial data at source. VAMP doctors are already trained to routinely use their computers for recording patient histories. They are now entering clinical trial data directly onto their computer systems using specially tailored screens. These extra screens form the basis of the electronic clinical trial systems. These systems allow: -
Highlighting of potential trial patients Automatic checking of inclusion and exclusion criteria Integration with existing medical and therapy history records Data validation at entry Automatic drug and disease coding On-screen protocol help - Fast data aggregation and analysis Four electronic clinical research systems in separate therapeutic areas have been developed and implemented to date. Their advantages and limitations will be discussed. A64 A METHODOLOGY TO PERFORM THE "PAPERLESS" CLINICAL TRIAL: OVERVIEW AND GENERAL PRINCIPLES James Roehon and Lance R. Bailey
Robarts Research Institute Ontario, Canada Data management in randomized clinical trials is an intricate and demanding process consuming a considerable amount of the resources of the study management center. The volume of data is typically quite large; the data themselves are heterogeneous in nature and collected from sources both geographically and temporally dispersed. Distributed data enta,y (DDE) systems have long been used to respond to this challenge. Personal computers are located at each of the clinical centers and software is written to screen for eligibility at patient entry, perform range checks and consistency checks as the data are entered and invoke skip patterns to avoid irrelevant sections of the data forms. Indeed, technology has progressed to the point where an deetronic dat__~basecan replace the paper Case Report Forms (CRF's) as the "official" repository of data collected from the trial. The sole justification for retaining the paper CRF's, however, is the requirement from regulatory agencies (and others) for a signature indicating legal, medical and academic responsibility for the data recorded therein. In this paper, we propose a methodology for performing the "paperless" clinical trial. The itie issue of data accountability will be addressed, that is, assigning responsibility for every data to a particular individual. Thus, this paper will describe: (1) Procedures to ensure that only authorized individuals add, modify and delete study data; (2) Desiderata for an electronic signature extending to all data fields; and (3) Data management principles to oversee the entire process.
~e~d
A65 A METHODOLOGY TO PERFORM THE "PAPERLESS" CLINICAL TRIAL: ELECTRONIC SIGNATURES FOR ELECTRONIC DATA Lance R. Bailey and James Rochon
Robarts Research Institute Ontario, Canada Electronic data collection has been shown to be an effective way of collecting information for large trials. Unfortunately, it lacks the authenticity and responsibility of a signed piece of paper, a drawback which stops a regulated trial from being completely electronic. Automated TeBer Machines (ATM) for banking services have broken through this barrier to allow millions of dollars each day to be transferred without the need for a paper signature. The magnetic-
426
Abstracts
stripe card and Personal Identification Number (PIN) allow a person to be uniquely identified to the machine. By combining ATM technology with remainder checksum algorithms such as used in computer data communications to ensure integrity, the author demonstrates an approach to which meets the desiderata for electronic signatures by providing the following: : no CRF is transmitted unless signed by at least two persons each piece of data is bound to the signatures s no piece of data may be altered without all signing parties resigning the data received information is confirmed against a protected, central master list of authorized persons An algorithm employing a cyclic redundancy code will be followed through to demonstrate how electronic signatures can be easily incorporated into transmitted data to provide both authenticity and
integrity. A66 AN INTEGRATED CLINICAL TRIAL DATABASE INTEGRITY EVALUATION SYSTEM (DIES) Mark A. Levinson and Mitchell Hiller
The EMMES Corporation Potomac, Maryland We have developed a system of programs called the Data Integrity Evaluation System (DIES) that allows for systematic examination of clinical trial master databases for most types of errors and omissions. At the heart of the system is a comprehensive data dictionary which defines all of the attributes of each variable used in the study. Most of the edit checks performed on master databases at the coordinating center are repetitive. DIES provides a mechanism to simplify the specification of these checks, to track the status of outstanding edit checks, and to generate meaningful reports, both for internal consumption and for transmission to clinical centers for remedial action. DIES provides the Data Manager, project programmer, or Pl with tools for defining which study files are to be examined and automatically builds base d~t~ dictionary entries for the variables in these files. The dsts dictionary can be enhanced with inner and outer range limits and labels. In building the inventory of edit checks for a project, tools are provided for defining which files are logically connected and the set of edit checks to be performed on them. This can be done either interactively or through a structured specification language. Tools are also provided for reviewing detected "anonudies" and designing reports for displaying them. DIES has been developed as a project independent software system with all information relevant to a project coded into meaningful tables. These tables serve as audit trails in that they contain detailed documentation of the evaluations performed, the anomalies detected, and the status of anomaly resolution. DIES has been successfully implemented into all ongoing studies supported by The EMMES Corporation. P01 EDUCATIONAL ACTIVITIES OF THE DUTCH WORKING GROUP FOR DATA MANAGERS Mildred C. Boon*, B. van den Bos, M. Harteveld, I. Mandjes and H. Smit
*University Hospital Leiden The Netherlands One of the aims of the Dutch Working Group for Data Managers is to provide their 60 members, working mainly in oncology, with educational possibilities. It has been recognized that high quality of data collection can only be reached when properly trained personal is available. Regular activities consist of two general meetings which cover different fields, one intensive workshop or course, training options in experienced centers and three newsletters per year. In 1992 the group has received an extra grant for educational purposes. This enabled us to provide 22 members with individual support to follow a course of their own choice and to organize extra plenary activities. An earlier performed inquiry showed that 93 % of the interviewed persons indicated that studying literature was one of the main options for further education. Applicable books are spread over many different fields as: medical statistics, epidemiology, informatics and oncology. Another category which is difficult to retrieve, but could be very useful for new data managers are unofficial editions like p.roceedings of meetings, course books and other not published material. A special data managers library, with a broad collection of titles has been set up, which is available for all members. A catalogue has been made, the first books have been ordered and the library is operational from November 1992.