Clinical Trial Data Management Technology Guide
https://translate.googleusercontent.com/translate fannexClinical trial data managementtechnology GuideI. OverviewClinical Trial Data quality is evaluated on thebasis of clinical trial results. In order to ensureaccurate and reliable results of clinical trials,scientific credibility of the international communityand countries in the world have issued a series ofrules, regulations and guidelines to regulate themanagement of clinical trial data of the entireprocess. Meanwhile, the progress of modern ogy, especially the development of computer,network and clinical trials and data managementstandardization provides a new technical support,also contributed to the Governments and theinternational community to actively explore theclinical test data management and standardizationof new models.(A) domestic regulatory status of clinical trialdata1 of 658/10/16, 6:15 AM
https://translate.googleusercontent.com/translate fChina's "Good Clinical Practice" (Good ClinicalPractice, GCP) clinical trial data managementrequirements put forward a number of principles, butregulatory and technical provisions on specific datamanagement operations is still in the blank. Due tothe lack of supporting technical guidelines, ourdegree of standardization in the pharmaceuticalclinical trial data management is not high, clinicaltrial data management quality varies greatly, therebyaffecting the objective scientific evaluation of theefficacy and safety of new drugs. In addition, thedomestic clinical trials, development and applicationof electronic data management system is still in itsinfancy, clinical trial data management patterns arelargely paper-based case report forms (Case ReportForm, CRF) data collection phase, electronic dataacquisition and data management system to be thepromotion and popularization. At the same time, dueto the lack of national data standards, it is difficult todo a similar study between database informationsharing.(Ii) International Clinical Trial Data ManagementOverviewInternationally, people use drugs TechnicalRequirements2 of 65forRegistrationInternational8/10/16, 6:15 AM
https://translate.googleusercontent.com/translate fConference on Harmonization of clinical study drugquality management practices (hereinafter referredto as ICH E6 GCP) for clinical trial data managementhas a principled requirements. For researchers tocarry out clinical trials, research and recordmanufacturers and responsibilities related to thetesting process, the source data, verification and soon, directly or indirectly made a principled provisionsto ensure that all types of data obtained in clinicaltrials true, accurate, complete and ns and guidelines provide specific evidenceand guidance for the standardization and regulationof clinical trial data management. Such as: (21 CFRPart11)ElectronicRecordsandElectronicSignatures rules of clinical trial data, 21 CFR Part res with the traditional handwritten recordsand handwritten signatures have the same the forceof law, so that the US food and Drug Administration(FDA) toacceptelectronicmaterials. Accordingly,theclinicalresearchFDA madeclearrequirement in August 2003 issued a correspondingtechnical guidelines, the provisions of Part 11 of the3 of 658/10/16, 6:15 AM
https://translate.googleusercontent.com/translate fmade specific interpretation and validation ofcomputer systems, inspection track record and filecopying and so on.In May 2007, "Guiding Principles of clinical trialsusing a computerized system," issued by the USFDA (Guidance for Industry: Computerized SystemsUsedin Clinical Investigations)for clinical trials in thedevelopment and use of computer systems toprovide a basic reference standard .And clinical trial data management by theInternational Society of relevant experts in the field(Society of Clinical Data Management, SCDM)alsoformed a "good clinical data management practices"(Good Clinical Data Management Practice,GCDMP),the file is clinical each key test data managementhad established a minimum standard correspondingoperation and the highest specifications, providingspecific technical guidance for practical clinical trialdata management.In summary, the international community andthe developed countries have established a numberof clinical trial data management regulations,regulations and technical guidelines in order toensure the quality of the test data. And in this regard4 of 658/10/16, 6:15 AM
https://translate.googleusercontent.com/translate fChina started late, slow development, clinical trialdata management standardization owe a directimpact on our drug discovery and supervision.Current national strategic plan of building aninnovative society requires special programs andmajor new drug clinical trial data managementstandardization made more urgent needs. In view ofits importance and urgency, in a positive summary ofthe current level of technology and research anddevelopment trend of clinical trial data management,based on the particular formulation of the technicalguidelines.This guide from the requirements of datamanagement responsibilities related to personnelqualifications and training, management systems,standardized test data, the main contents of datamanagement,dataqualityassuranceandassessment, as well as six aspects of data retation aimed at data management of clinicaltrials to play the role of standardization andguidance, applicable to the registration of drugs forthe purpose of clinical trials, post-marketing clinicaltrials and for other types of tests are also instructive.Second,5 of 65theresponsibilityfordata8/10/16, 6:15 AM
https://translate.googleusercontent.com/translate fmanagement related to personnel qualificationsand trainingClinical trial data management requirements forclinical trials research project team effort and fullcooperation. Research and data management staffinvolved in work-related sponsors, investigators,auditors, data administrators, and contract researchorganizations (ContractResearchOrganization,CRO) and the like.Liability (a) the relevant personnel1. SponsorThe sponsor is to ensure the quality of clinicaldata ultimately responsible. The sponsor shoulddevelop quality management evaluation ldandestablishoperationalinspectiondepartment, the sponsor can audit their own whennecessary, quality system compliance systematicinspection by personnel not directly involved in thetest on a regular basis. In addition, the sponsorshould ensure data integrity, and compliance withsupervisory responsibility for the data managementprocess, compliance, and data quality of CROincluding6 of 65outsourcingwhen appropriatework8/10/16, 6:15 AM
https://translate.googleusercontent.com/translate nt aspects, for example: researchersuntrained and fill in the CRF; research programs isnot clear or unreasonable.2. ResearchersResearchers should ensure that CRF or otherform of a report to the sponsor's data is accurate,complete and timely, and should ensure that thedata on the CRF from the source data records on thesubject, and must be given for any differentinterpretation of them.Researchers error in the data managementaspects / misconduct example: violation of the studyprotocol, such as the wrong time to visit; the sourceCRF data entry errors;laboratoryinstrumentsartificial measurement error; fill in the CRF does nothave the qualified personnel; researchers fraud.3. auditorsInspectors should be based on the data sourcedocument verification CRF, once you found an erroror difference shall notify the investigator, andaccording to errors or discrepancies found, recordthe appropriate question to ensure that the recording7 of 658/10/16, 6:15 AM
https://translate.googleusercontent.com/translate fand reporting of all data correctly and complete.CRA common problems, for example: nooriginal medical or original medical records norecords (missing or incomplete); CRF fill vacancies inerrors or irregularities; recording adverse events isincomplete; unreported suspected fraud to thesponsor; test The results can not be traceable(laboratory data, ECG, X-ray films, etc.).4. Data irements of the research program, in the designof CRF, to establish a database of data managementstandards and establish inspection procedures andtest logic. After receiving CRF, CRF entry personnelto make checks on entry before; after CRF data isentered into the database, the use of validity,consistency, and lack of the normal range logic testprogram to check the data and the like. Dataadministrators discovered the problem should beclearedup,dataissuedbytheinvestigatorquestioned (Query) be resolved.Data administrators should participate in clinicalinvestigator meetings for the study team timely andeffective measures to improve and enhance the8 of 658/10/16, 6:15 AM
https://translate.googleusercontent.com/translate fquality of data.A default data administrator Example: CRF tabledesign does not meet program requirements; logictest program error; described in language inquestion has induced ingredient; in the wrongquestion to update the database.5. Contract Research Organization (CRO)ICH GCP may be noted that the sponsor ofclinical trials related work and tasks entrusted to partor all of a CRO, but the ultimate responsibility for thequality and integrity of the trial data always sponsor.CRO should implement quality assurance and qualitycontrol.The sponsor should first clarify the scope ofdata management outsourcing, if you plan tooutsource the management of data, then the nextstep is to choose the right CRO, CRO cope with thecandidate's qualifications and ability to evaluate.Evaluation CRO should consider the followingfactors: CRO qualifications, past performance and itsability to perform the contract; quality control, icationandfacilities;datadatamanagement SOPs (Standard Operating Procedure,9 of 658/10/16, 6:15 AM
https://translate.googleusercontent.com/translate fSOP) and proof of compliance with SOP;staffqualifications, to grasp the situation of the SOP andtraining records; record document change controlprocess; a file storage system.Upon election, the sponsor and CRO will sign avalid contract, the two sides in the contract withexplicit responsibilities, rights and interests. Trialsponsors to respond when necessary CRO-relatedtraining to ensure that the services they providemeet the sponsor's quality standards. In the clinicaltrial data management process, the need for trialsponsors activities carried CRO timely and effectivemanagement, communication and verification, inorder to ensure compliance with mutually nt plan must include CRO quality controlinformation, and the process must be clear andexpected results.Qualification and Training (ii) data managementstaffResponsible for clinical trial data managementmust go through GCP, professional training relevantlaws and regulations related to SOP, and datamanagement to ensure its proper qualifications with10 of 658/10/16, 6:15 AM
https://translate.googleusercontent.com/translate fjob requirements.Data management professional training shallinclude, but are not limited to: Data ManagementSOP and sectoral policies; standardization of clinicaltrial data and document archiving rules; training atedcomputeroperatingcapacity;regulations and industry standards: GCP , CFDAregulations and guidelines, and ICH guidelines;confidentiality, privacy and data security training.Data managers must preserve the integrity oftraining records for verification, training recordsrequired course name, date, name of the pervisors signature. If it is web-based trainingsystem should provide proof of training, indicatingthe name of the course, trainees names, as well astraining time to complete.Data managers should also ofessional quality, to ensure high-quality datamanagement.Third, the clinical trial data managementsystemThe11 of 65importanceof(a)clinicaltrialdata8/10/16, 6:15 AM
https://translate.googleusercontent.com/translate fmanagement systemObjective data management is to ensure thatthe data is reliable, complete and accurate. Datamanagement process including the collection /management system is established, the design CRFand database data receiving input, data verificationand questioning, medical coding, external datamanagement, blind review, database locking, dataexport and transfer of data and data managementdocuments the archiving. Object data managementis to achieve high-quality real data. Thus, the variousstages of clinical trial data management needs torun in a complete, reliable clinical trial datamanagement system, clinical trials project teammust establish a management system in nagement systems, data may affect the quality ofthe results various factors and aspects of full controland management of these factors are under control,so that clinical research data is always maintained ina controlled and reliable level. Data managementsystem here does not mean the narrow sense of thecomputer system, but a generalized data qualitymanagement system (Quality Management System,12 of 658/10/16, 6:15 AM
https://translate.googleusercontent.com/translate fQMS), which is an integral part of the clinical trialproject management system.The establishment and implementation (ii) thedata quality management systemEstablish a data quality management system isthe application of scientific management, improvethe management level, the process of y management system first need to establishquality policy and objectives, in order to determinethe expected results, helping managers to use itsresources to achieve these results. Quality is qualityobjectives and direction of managers, qualityobjectives are specific policy, a manager in thequality of the objective pursued.Quality management systems rely on theorganization to coordinate and run, we mustestablish the organizational structure of a qualitymanagement system to adapt. Organizations shouldbe clearly defined responsibilities and authority datamanagement-related personnel.Implementation and operation of the qualitymanagement system through the establishment ofimplementing the quality management system file toachieve.13 of 65Qualitymanagementsystem8/10/16, 6:15 AM
https://translate.googleusercontent.com/translate fdocumentation generally consists of four ality records. Quality Manual is the core quality system elements of description; program filesis complete the quality of activities of method madeprovisions; operating instructions is to provide aparticular job specific operating procedures of files,data administrator is commonly used "operatingManual" or "rules," and the like; quality records forcompleted activities or results achieved provideobjective evidence file.After completion of the quality managementsystem documents, over a period of trial operation,testing the applicability and effectiveness of thesequality management system documents. ontrol,continuousinformationmanagement, quality management system auditsand management review, to achieve the effectiveoperation of the quality management system.Establishmentofdataqualitysystemmanagement, implementation and operation is adynamic process, the most important is the datamanagement14 of 65requirementsrelatedtoquality8/10/16, 6:15 AM
https://translate.googleusercontent.com/translate fmanagement personnel to implement the conceptinto the daily work of data management.(Iii) the basic requirements of clinical trial datamanagement system1. System ReliabilitySystem reliability is the ability of the systemunder specified conditions, within the specified time,to achieve the specified functions. Clinical trial datamanagementsystemmustbebasedonaconsideration of the risks, in order to ensure dataintegrity, security and credibility, and reduce thepossibility of problems due to system or processgenerates an error.Computerized data management system mustbe rigorous design and verification, and formvalidation summary report to verify the need toprepare regulatory agencies, which prove thereliability of management systems.2. Clinical trial data traceabilityThe clinical trial data management system mance for the clinical trial data. CRF datashould be consistent with the source file, anydiscrepancy should be explained. Any changes orcorrections should be dated, signed and explain why15 of 658/10/16, 6:15 AM
https://translate.googleusercontent.com/translate fthe name of CRF in the data (if necessary), and shallmake the original record is still visible.Track inspectors clinical trial data (Audit Trail),from the first data entry as well as every change,deletion or addition, must remain in the clinical trialsdatabase system. Date of inspection should includechanging the trajectory, time, change the people,change reasons, the data value before the change,the changed data values. This track inspectionsystem protection, does not allow any artificialmodification and editing. Inspection records shouldbe kept on track and query.3. Rights Management Data ManagementSystemThe clinical trial data management system musthavecompleterightsmanagementsystem.Paper-based or electronic data management arerequired to develop SOPs control permissions(Access Control) and management. Grant differentrights to the data management system in differentpeople or roles that only authorized personnel areallowed to operate (record, modify, etc.), and shalltake appropriate methods to monitor and preventpeople not authorized to operate.16 of 658/10/16, 6:15 AM
https://translate.googleusercontent.com/translate fElectronic Signature (Electronic Signature) is Forsystemelectronicmanagement system, each user of the systemshould have a personal account, the systemrequirements before you begin operating data to belogged in account, quit the system after completion;users can work with their password, the passwordcan not be shared, nor let others access login;password should be changed periodically; when youleave your workstation and terminate the connectionto the host computer is idle for a long time toimplement disconnect itself; a short pause whenwork should have automatic protection proceduresto prevent unauthorized data operations, such asthe use of protective measures in front of the screento enter the password.Fourth, standardized test dataClinical trial data standardized meaning is: astandardized data format is the basis of clinical trialdata management system and the clinical trials ofmedical institutions to establish interoperabilityinformation; establish a seamless data exchangebetween different studies internal sponsor, and thesponsor between communication, communication17 of 658/10/16, 6:15 AM
https://translate.googleusercontent.com/translate fbetweenthesponsorandthedrugreviewmechanism to facilitate; facilitate clinical trials foreach drug safety data sharing; easy to inspect themetadata (meta data) stemsandapplication programs data integration provides aunified technical standards; facilitate the reviewmechanism, so as to shorten the approval cycle;helps to enhance the quality of data, we can pro
technology Guide I. Overview Clinical Trial Data quality is evaluated on the basis of clinical trial results. In order to ensure accurate and reliable results of clinical trials, scientific credibility of the international community and countries in the world have issued a series of rules, regulations and guidelines to regulate the
need clinical trial management information to support newly emerging areas such as clinical trial disclosure and risk-based monitoring (RBM). In addition, external partners including regulatory agencies and co-development collaborators require an expanding range of trial information. 3.Increased outsourcing of clinical trials.
Visualizing Clinical Trial Data: Small Data, Big Insights Michael Drutar and Elliot Inman, SAS Institute Inc., Cary, NC ABSTRACT Data visualization is synonymous with big data, for which billions of records and millions of variables are analyzed simultaneously. But that does not mean that data scientists analyzing clinical trial data that
Chapter 3 Protection of Trial Subject's Right . Chapter 4 Clinical Trial Protocol . Chapter 5 Responsibilities of the Investigator . . should be adopted as guiding principles by those conducting the clinical trial for proprietary Chinese medicines. 2. The guidelines serve as the standard requirement for the process of a clinical trial,
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