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Validating a Clinical Data System: Technical, Organizational, and Managerial Aspects 验证临床数据系统:技术、组织和管理方面
Drug Information Journal Pub Date : 1993-04-01 DOI: 10.1177/009286159302700204
Robbert P. van Manen, K. D. de Neef
{"title":"Validating a Clinical Data System: Technical, Organizational, and Managerial Aspects","authors":"Robbert P. van Manen, K. D. de Neef","doi":"10.1177/009286159302700204","DOIUrl":"https://doi.org/10.1177/009286159302700204","url":null,"abstract":"After a brief introduction on the reasons for validating a clinical data system, this paper will provide a description of the organizational and technical environment in which validation at Organon International took place, followed by an overview of the actual audit that has been performed, and the project that was undertaken to arrive at a validated clinical data system. Organon's experiences and observations during these activities and plans for the future will be covered.","PeriodicalId":51023,"journal":{"name":"Drug Information Journal","volume":"27 1","pages":"245 - 252"},"PeriodicalIF":0.0,"publicationDate":"1993-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/009286159302700204","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"64843265","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 1
ISO 9000 and Its Relation to System Validation iso9000及其与体系验证的关系
Drug Information Journal Pub Date : 1993-04-01 DOI: 10.1177/009286159302700208
M. D. de Feu
{"title":"ISO 9000 and Its Relation to System Validation","authors":"M. D. de Feu","doi":"10.1177/009286159302700208","DOIUrl":"https://doi.org/10.1177/009286159302700208","url":null,"abstract":"An important prerequisite to having confidence in a computer system is the construc­ tion of good quality assurance and quality control programs during the development of the product. The ISO 9000/EN 29000 is a very useful standard for developing a quality system for the development, supply, and maintenance of software. This pa­ per discusses the different subjects of the ISO 9000/EN29000 standard and indicates the documents where guidance for the application of the standard to software can be found. The end of the paper deals with the importance of certification of the com­ pany's quality system by a third party. Certification adds to the credibility of a sup­ plier and can be considered evidence of good practice.","PeriodicalId":51023,"journal":{"name":"Drug Information Journal","volume":"27 1","pages":"275 - 280"},"PeriodicalIF":0.0,"publicationDate":"1993-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/009286159302700208","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"64843274","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Experience of the Netherlands Regulatory Agency with EC Concertation Procedures 荷兰监管机构处理欧共体协调程序的经验
Drug Information Journal Pub Date : 1993-01-01 DOI: 10.1177/009286159302700117
W. F. van der Giesen
{"title":"Experience of the Netherlands Regulatory Agency with EC Concertation Procedures","authors":"W. F. van der Giesen","doi":"10.1177/009286159302700117","DOIUrl":"https://doi.org/10.1177/009286159302700117","url":null,"abstract":"The experience of the Dutch Medicines Evaluation Board as rapporteur in the concertation procedure has been a successful learning experience. We begin with informative discussions with the applicant in the presubmission phase, emphasizing close contact between the company and the authority experts. After the dossier is sent and objections come in from the Member States, we prepare a clear, consolidated list of objections. When the applicant replies, we make an assessment report on that reply. In most cases, agreement is reached on one single summary of product characteristics, and harmonization is achieved.","PeriodicalId":51023,"journal":{"name":"Drug Information Journal","volume":"27 1","pages":"81 - 85"},"PeriodicalIF":0.0,"publicationDate":"1993-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/009286159302700117","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"64843257","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Did My Drug Cause This? a Biostatistical Perspective 是我的药物引起的吗?生物统计学视角
Drug Information Journal Pub Date : 1992-10-01 DOI: 10.1177/009286159202600415
M. V. Von Tress
{"title":"Did My Drug Cause This? a Biostatistical Perspective","authors":"M. V. Von Tress","doi":"10.1177/009286159202600415","DOIUrl":"https://doi.org/10.1177/009286159202600415","url":null,"abstract":"The role of conditional probability in evaluating causes of adverse reactions is stud­ ied. Conditional probability is used in both randomized clinical trials and in postmar­ keting surveillance for identification of causality. The identification of cause is greatly simplified in randomized controlled trials because direct comparisons may be made on patients taking the drug against those who did not. Determination of cause in postmarketing surveillance is more difficult because there is no comparison group. Conditional probability, as expressed by Bayes rule, may be used in this setting. A method for evaluating the sensitivity of Bayesian methods to the assumptions about prior probabilities will be presented.","PeriodicalId":51023,"journal":{"name":"Drug Information Journal","volume":"26 1","pages":"565 - 572"},"PeriodicalIF":0.0,"publicationDate":"1992-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/009286159202600415","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"64843213","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Overview of the Use of Food/Natural Products as Drugs 食品/天然产品作为药物使用的概述
Drug Information Journal Pub Date : 1987-04-01 DOI: 10.1177/009286158702100217
A. Der Marderosian
{"title":"Overview of the Use of Food/Natural Products as Drugs","authors":"A. Der Marderosian","doi":"10.1177/009286158702100217","DOIUrl":"https://doi.org/10.1177/009286158702100217","url":null,"abstract":"Higher plants produce numerous extractable organic substances which are in great demand throughout the world. These include both primary and secondary metabolites. The primary metabolites (carbohydrates, polysaccharides) are high volume and low value bulk materials while the secondary metabolites (drugs, flavorings, pesticides) are high value, low bulk subsfances. This overview presenfs numerous economically important plant drugs of current importance with sources and some prices, along with difficulties in handling. I n addition, numerous nutritional products of natural origin are given with their uses and purporled medical value. Reference sources of information on these is also provided.","PeriodicalId":51023,"journal":{"name":"Drug Information Journal","volume":"158 1","pages":"229 - 243"},"PeriodicalIF":0.0,"publicationDate":"1987-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/009286158702100217","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"64843071","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 1
Analysis and control of costs associated with answering drug information requests. 分析和控制与回复药品信息请求相关的成本。
Drug Information Journal Pub Date : 1987-01-01 DOI: 10.1177/009286158702100214
F F Hermann, L A Wanke
{"title":"Analysis and control of costs associated with answering drug information requests.","authors":"F F Hermann,&nbsp;L A Wanke","doi":"10.1177/009286158702100214","DOIUrl":"https://doi.org/10.1177/009286158702100214","url":null,"abstract":"<p><p>A strategy is proposed for estimating the average cost of answering drug information requests, comparing the factors that influence cost and controlling that cost. The cost for answering a request is based on the time it takes to answer the request, the salary of the person who answers the request, the cost of the information sources used to find the answer, and, indirectly, the frequency of requests of the same type. Request types have been defined by scope of search and formal of answer required, as textbook search/verbal answer, literature search/verbal answer, and literature search/written answer request. An empirical formula was used to calculate average costs for each request type at the Oregon Poison Control and Drug Information Center. A simple computer program was then used to generate costs over a range of changes that could be considered reasonable for each factor. The effect of modifying any of the factors in this formula demonstrated that a low volume of requests brings about the most critical change. Cost changes abruptly and may become unjustifiably high. If, for example, the volume of requests requiring literature search and verbal answer is 30 per month, the average cost for a request is $29.13; at a volume of 10 per month, the cost is $35.93; and at a volume of one per month the cost is $127.65. It is suggested that hospital pharmacy departments experiencing small frequencies of certain types of request analyze the cost in this manner and, if necessary, adopt a method for controlling the cost.</p>","PeriodicalId":51023,"journal":{"name":"Drug Information Journal","volume":"21 2","pages":"209-16"},"PeriodicalIF":0.0,"publicationDate":"1987-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/009286158702100214","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"21153015","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 4
Some observations on the collection of medical event data. 关于医疗事件数据收集的一些意见。
Drug Information Journal Pub Date : 1987-01-01 DOI: 10.1177/009286158702100110
N R Mohberg
{"title":"Some observations on the collection of medical event data.","authors":"N R Mohberg","doi":"10.1177/009286158702100110","DOIUrl":"https://doi.org/10.1177/009286158702100110","url":null,"abstract":"<p><p>A review of the philosophy, strategies, and methods for the collection of medical event (ME) information in clinical trials sponsored by the Research and Development Division of THe Upjohn Company is presented. Goals for collection of ME information for Phase I, II, and III trials are reviewed. Case report form and terminology issues are discussed, with particular emphasis placed on procedures that avoid premature decisions on ME causality and incomplete reporting of events. Procedures for separating the seriousness from the intensity of the MEs are reviewed. Analysis issues are considered insofar as they impact on data collection procedures and goals. Recommendations are made with respect to protocol content, data collection forms, and related analysis issues.</p>","PeriodicalId":51023,"journal":{"name":"Drug Information Journal","volume":"21 1","pages":"55-62"},"PeriodicalIF":0.0,"publicationDate":"1987-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/009286158702100110","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"21171360","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 1
Preparation and maintenance of prescription drug labeling. 处方药标签的制作和维护。
Drug Information Journal Pub Date : 1987-01-01 DOI: 10.1177/009286158702100207
M P Fisher
{"title":"Preparation and maintenance of prescription drug labeling.","authors":"M P Fisher","doi":"10.1177/009286158702100207","DOIUrl":"https://doi.org/10.1177/009286158702100207","url":null,"abstract":"<p><p>This article describes procedures used to prepare and maintain prescription drug labeling beginning with a brief overview of the statutory and regulatory requirements. Discussed is the labeling format prescribed by FDA regulation and the type of information needed for the key labeling components. The article provides a description of typical company approaches for developing and approving the labeling text. Discussed are the multi-disciplinary groups responsible for preparing and approving the copy with comparison to an analogous multi-disciplinary group at the FDA which has responsibility for review and approval of labeling submitted with regulatory documents. Discussed also is the need for international labeling consistency for drugs which are marketed in countries other than the U.S. Reference is made to security considerations regarding the approved copy.</p>","PeriodicalId":51023,"journal":{"name":"Drug Information Journal","volume":"21 2","pages":"153-7"},"PeriodicalIF":0.0,"publicationDate":"1987-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/009286158702100207","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"21153012","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Data on drugs and adverse experiences: moving from the specific to the general. 关于药物和不良经历的数据:从具体到一般。
Drug Information Journal Pub Date : 1987-01-01 DOI: 10.1177/009286158702100107
D B Windhorst, E F Pun, L A Zubkoff
{"title":"Data on drugs and adverse experiences: moving from the specific to the general.","authors":"D B Windhorst,&nbsp;E F Pun,&nbsp;L A Zubkoff","doi":"10.1177/009286158702100107","DOIUrl":"https://doi.org/10.1177/009286158702100107","url":null,"abstract":"<p><p>Summary displays of data should illustrate narrative points made about the clinical experiment. Documentation of the source of the information selected for the critical displays should be assembled based on the data reduction steps that have occurred. Understanding and systematizing the presentation of the data reduction steps will facilitate the review of complex adverse experience data bases and allow well-informed decisions about the safety information.</p>","PeriodicalId":51023,"journal":{"name":"Drug Information Journal","volume":"21 1","pages":"39-46"},"PeriodicalIF":0.0,"publicationDate":"1987-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/009286158702100107","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"21171358","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 1
FDA's conduct, review, and evaluation of inspections of clinical investigators. FDA的行为，审查和评估临床研究人员的检查。
Drug Information Journal Pub Date : 1987-01-01 DOI: 10.1177/009286158702100202
G Turner, A B Lisook, D P Delman
{"title":"FDA's conduct, review, and evaluation of inspections of clinical investigators.","authors":"G Turner,&nbsp;A B Lisook,&nbsp;D P Delman","doi":"10.1177/009286158702100202","DOIUrl":"https://doi.org/10.1177/009286158702100202","url":null,"abstract":"<p><p>This review of the Food and Drug Administration's Bioresearch Monitoring Program focuses on the inspection of clinical investigators who study investigational drugs. The differences between routine, \"for-cause,\" and bioequivalency/bioavailability inspections are examined, with emphasis on the responsibilities of the clinical investigator, reasons for conducting the inspections, and problems found. Important aspects of the inspection report, such as protocol adherence, records maintenance, informed consent, institutional review board approval, and drug accountability, are outlined. The disqualification and consent agreement processes for investigators with serious problems are explained. FDA policies on third-party notification and remote data entry are noted.</p>","PeriodicalId":51023,"journal":{"name":"Drug Information Journal","volume":"21 2","pages":"117-25"},"PeriodicalIF":0.0,"publicationDate":"1987-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/009286158702100202","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"21153009","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 4
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