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OpenCDISC. org — an open source initiative delivering tools for validation of CDISC data OpenCDISC。org——一个开源项目，提供用于验证CDISC数据的工具
Pharmaceutical Programming Pub Date : 2010-12-01 DOI: 10.1179/175709310X12849953957960
M. Kanevsky, N. Both, Tim D. Stone
{"title":"OpenCDISC. org — an open source initiative delivering tools for validation of CDISC data","authors":"M. Kanevsky, N. Both, Tim D. Stone","doi":"10.1179/175709310X12849953957960","DOIUrl":"https://doi.org/10.1179/175709310X12849953957960","url":null,"abstract":"AbstractFor several years, the FDA has requested that sponsors submit clinical trial data in CDISC SDTM format. Recently, the FDA has begun requiring submissions of other forms of data to be in standardized CDISC formats, for example, CDISC ADaM for analysis data, and CDISC SEND for animal toxicology studies. While commercial tools have been available to validate CDISC SDTM data since the beginning of this standardsadoption process, they have not been freely available to everybody. OpenCDISC. org was initiated in 2008 as an open source community dedicated to the creation of extensible tools for the implementation of CDISC standards, with an initial focus on data validation. The OpenCDISC Validator is built using Java and is configurable so that it can check not only various versions of CDISC data, but can also be tailored to meet the specific needs of a particular submission or a particular setting within a pharmaceutical company. The tool is configured using XML files, which can be modified or created us...","PeriodicalId":253012,"journal":{"name":"Pharmaceutical Programming","volume":"78 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2010-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"132225853","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
Solving KenKen puzzles — by not playing 解决KenKen谜题——不玩
Pharmaceutical Programming Pub Date : 2010-12-01 DOI: 10.1179/175709310X12847352884285
J. Gerlach
{"title":"Solving KenKen puzzles — by not playing","authors":"J. Gerlach","doi":"10.1179/175709310X12847352884285","DOIUrl":"https://doi.org/10.1179/175709310X12847352884285","url":null,"abstract":"AbstractSolving KenKen puzzles requires more than making sure that numbers are used only once in a row and column of a matrix. Unlike Sudoku puzzles that can use any symbol and have sub-matrices, KenKen puzzles require actual integers and have contiguous cells, called cages. And, unlike a sub-matrix that contains a unique collection of numbers or symbols, KenKen puzzles have cages that must contain natural numbers representing a total as a function of its assigned arithmetic operation. For example, consider a 4 X 4 KenKen puzzle having a cage containing three cells whose total is 11 as a function of simple addition. One possible set of three numbers would be: 4 + 3 + 4 = 11. The objective is to complete the grid using numbers ranging from 1 to N that satisfies both cage arithmetic and row/column uniqueness. Depending on the size of the N X N grid, the number (and size) of the cages, as well as the arithmetic operations used, a KenKen puzzle offers a formidable challenge for logic puzzle fans. However, rat...","PeriodicalId":253012,"journal":{"name":"Pharmaceutical Programming","volume":"127 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2010-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"115920750","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
Efficient programming methods using metadata 使用元数据的高效编程方法
Pharmaceutical Programming Pub Date : 2010-12-01 DOI: 10.1179/175709310X12847368100142
K. E. Homer
{"title":"Efficient programming methods using metadata","authors":"K. E. Homer","doi":"10.1179/175709310X12847368100142","DOIUrl":"https://doi.org/10.1179/175709310X12847368100142","url":null,"abstract":"AbstractEfficient programming methods using metadata will save time, money, and facilitate communication across the study team. The information stored in the metadata files will be used as input into either a SAS® code generator or SAS macros to generate the required outputs. This programming style has been used for generating edit checks, data dumps, patient profiles, data listings, tables, and graphs both successfully and efficiently.","PeriodicalId":253012,"journal":{"name":"Pharmaceutical Programming","volume":"34 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2010-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"129545153","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
Creating NONMEM datasets — how to escape the nightmare 创建NONMEM数据集-如何摆脱噩梦
Pharmaceutical Programming Pub Date : 2010-12-01 DOI: 10.1179/175709310X12847285433037
Shafi Chowdhury
{"title":"Creating NONMEM datasets — how to escape the nightmare","authors":"Shafi Chowdhury","doi":"10.1179/175709310X12847285433037","DOIUrl":"https://doi.org/10.1179/175709310X12847285433037","url":null,"abstract":"AbstractPharmacokinetics (PK) is the impact of the body on the drug and pharmacodynamics (PD) is the impact of the drug on the body. The effect of the drug on the target population of patients is predicted using models during population PK/PD analysis. This type of analysis is becoming more and more common in clinical trials, but creating the dataset structure required by the widely used non-linear mixed effects modelling software called NONMEM® is often the nightmare part of the process. It usually takes months to prepare the NONMEM dataset before the pharmacokineticist feels that it is ready for them to use. It is also produced after unblinding, adding to the delay in finalising the dataset before analysis can be performed with it. This delay can lead to holding back decisions about future trials, or those decisions are then made without taking into account the population PK analysis report. This paper will look at the issues which cause problems when creating a NONMEM dataset, and what steps we can tak...","PeriodicalId":253012,"journal":{"name":"Pharmaceutical Programming","volume":"18 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2010-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"127766543","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
Validating and documenting CDISC datasets with SAS® BASE — the SAS clinical standards toolkit 使用SAS®BASE (SAS临床标准工具包)验证和记录CDISC数据集
Pharmaceutical Programming Pub Date : 2010-12-01 DOI: 10.1179/175709310X12845608594267
A. Mangold
{"title":"Validating and documenting CDISC datasets with SAS® BASE — the SAS clinical standards toolkit","authors":"A. Mangold","doi":"10.1179/175709310X12845608594267","DOIUrl":"https://doi.org/10.1179/175709310X12845608594267","url":null,"abstract":"AbstractThe SAS Clinical Standards Toolkit provides a framework for validating and documenting CDISC-compliant data. It is a free add-on package for SAS software available under Microsoft Windows and UNIX. At present, it contains the validation of datasets according to the SDTM model (inclusive of published WebSDM™ and Janus checks) plus the generation of a data definition document following CRT-DDS (define. xml) for the submission. As all metadata and rules reside in SAS tables, other standards or new versions of existing standards can be retrofitted. To begin with, this paper will outline the meaning of such a tool within the scope of CDISC-compliant data management. Following that, the concept of the SAS Clinical Standards Toolkit will be presented and some examples for usage and results will be given. Finally, the adaptability of the tool will be expanded upon and some practical hints will be given.","PeriodicalId":253012,"journal":{"name":"Pharmaceutical Programming","volume":"10 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2010-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"129470064","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
A resource shared is a resource not wasted — flexible resourcing! 资源共享就是资源不浪费——灵活的资源分配!
Pharmaceutical Programming Pub Date : 2010-12-01 DOI: 10.1179/175709310X12849951397117
J. Gallagher, N. Malhotra
{"title":"A resource shared is a resource not wasted — flexible resourcing!","authors":"J. Gallagher, N. Malhotra","doi":"10.1179/175709310X12849951397117","DOIUrl":"https://doi.org/10.1179/175709310X12849951397117","url":null,"abstract":"AbstractMany projects have to cope with changes in demands and scope throughout their lifecycle. This particularly applies in the pharmaceutical industry due to the very nature of clinical trial data reporting. How often do we hear the phrase, 'the goal posts have moved' and with this, peaks and troughs accordingly. Add in other projects going through similar scenarios, competing for the same resources, and we end up with many disgruntled Lead Programmers! A solution employed by Roche is a resourcing model that mitigates the issues that arise from the described scenarios, adopting a resource model that utilizes core and flexible resources in different manners. There are many benefits from centralising a flexible pool of resources while having core resources continually assigned on the project.","PeriodicalId":253012,"journal":{"name":"Pharmaceutical Programming","volume":"7 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2010-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"127815973","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
At what price — dynamism in EDC 代价是什么? EDC的活力
Pharmaceutical Programming Pub Date : 2010-12-01 DOI: 10.1179/175709310X12845438122755
Geoff Low
{"title":"At what price — dynamism in EDC","authors":"Geoff Low","doi":"10.1179/175709310X12845438122755","DOIUrl":"https://doi.org/10.1179/175709310X12845438122755","url":null,"abstract":"Abstract In the beginning, there was the case report form (CRF), printed in NCR, bound and sent to site. It was obvious what data the sites needed to complete. Today, Electronic Data Capture (EDC) systems can make this less transparent as some data fields will remain hidden until a key question is completed; this functionality can be called 'dynamic questions'. The dynamic question approach reduces the amount of validation required as, if the dependent field is missing, there is no chance of any unexpected data being recorded. However, should the key variable be queried and the site staff change the result, where do the data from the dynamic pages go? To further complicate life, the idea of dynamic pages or dynamism no longer stops at the CRF. We see more and more complex trial designs, where a given subject can traverse the protocol defined assessments following a number of paths. Not only can a single data point change the appearance of a single CRF, but even direct the subject's progress through the wh...","PeriodicalId":253012,"journal":{"name":"Pharmaceutical Programming","volume":"18 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2010-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"121344597","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
Result disclosure on ClinicalTrials. gov — first experiences and challenges 临床试验结果披露。政府优先的经验和挑战
Pharmaceutical Programming Pub Date : 2010-12-01 DOI: 10.1179/175709310X12845438122791
R. Minkenberg
{"title":"Result disclosure on ClinicalTrials. gov — first experiences and challenges","authors":"R. Minkenberg","doi":"10.1179/175709310X12845438122791","DOIUrl":"https://doi.org/10.1179/175709310X12845438122791","url":null,"abstract":"AbstractThe disclosure of clinical trial 'basic' results on the website ClinicalTrials. gov has been legally required since September 2008 for all FDA-approved trials or cleared drugs and devices. Since that time, many additions (e.g.adverse event reporting in September 2009) and corrections (both content and format related) have been implemented. As most of the information needed for ClinicalTrials. gov is created anyway during the analysis and reporting of a clinical trial, a well-defined process can be established to collect the needed results during the programming of tables and listings for the trial report. In addition, the ongoing changes in the disclosure requirements and the different responsibilities and functions involved in trial disclosure lead to many challenges in defining and establishing such a process. This paper will focus on the process definition and execution from the programmer's perspective. We will also discuss common pain points of interpreting the ClinicalTrials. gov requirements.","PeriodicalId":253012,"journal":{"name":"Pharmaceutical Programming","volume":"52 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2010-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"114842314","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: 10
Convert dataset variables into macro variables: a new approach with the CALL SET routine and the SCL FETCH function 将数据集变量转换为宏变量:使用CALL SET例程和SCL FETCH函数的新方法
Pharmaceutical Programming Pub Date : 2010-12-01 DOI: 10.1179/175709310X12847333613574
Patrice Agator
{"title":"Convert dataset variables into macro variables: a new approach with the CALL SET routine and the SCL FETCH function","authors":"Patrice Agator","doi":"10.1179/175709310X12847333613574","DOIUrl":"https://doi.org/10.1179/175709310X12847333613574","url":null,"abstract":"AbstractA new approach using the CALL SET routine and the SCL FETCH function together to convert dataset variables into macro variables is presented in this article. With this new approach, the SAS programming code is reduced and simplified, and it becomes easier than ever to produce multiple and customized reports dynamically. SAS programmers will be able to implement this new and powerful technique by applying the few lines of SAS code attached in the conclusion section.","PeriodicalId":253012,"journal":{"name":"Pharmaceutical Programming","volume":"4 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2010-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"115747252","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
AstraZENeca and the A&RT of metadata maintenance 阿斯利康和A&RT的元数据维护
Pharmaceutical Programming Pub Date : 2010-12-01 DOI: 10.1179/175709310X12843849199108
P. A. Frost
{"title":"AstraZENeca and the A&RT of metadata maintenance","authors":"P. A. Frost","doi":"10.1179/175709310X12843849199108","DOIUrl":"https://doi.org/10.1179/175709310X12843849199108","url":null,"abstract":"AbstractThe use of metadata to drive dynamic programming is a common and well documented process, from Oracle H system tables to the SAS ® SQL dictionary tables. Analysis and Reporting Technology (AR leveraging structural hierarchy (an arrangement of items, e. g. objects, names, values, categories, etc., in which the items are represented as being 'above', 'below', or 'at the same level as' one another and with only one 'neighbour' above and below each level), equivalence (assigning one object to another) and inheritance (a way to form new classes, instances of which are called objects, using classes that have already been defined. Inheritance is intended to help reuse existing code with little or no modification), together with the collection of metadata ahead of time to streamline the process and minimize resource intensive activities on the critical path t...","PeriodicalId":253012,"journal":{"name":"Pharmaceutical Programming","volume":"60 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2010-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"126285275","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
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