Clinical information tends to be more complex, comes from multiple sources in different formats. As a result, clinical data submission has become time-consuming, costly and error-prone. CDISC® (Clinical Data Interchange Standards Consortium) established new data standards to speed up data-review and improve clinical data exchange, storage and archival. Our technology edge combined to our experience in standards implementation allows us to develop tailored CDISC solutions to accelerate your FDA review. Clinovo introduced a new opportunity to learn these recognized clinical data standards!
Clinovo’s new “CDISC Standards: Theory and Application” class is an 8-week training program starting in June 11th, 2013. The TechTrainings are technical hands-on classes for entry-level or experienced clinical trial professionals designed to help them reach the next step in their professional career. The class will be held in Palo Alto at Dentons Offices or remotely.
Taught by Sy Truong, President at Meta-Xceed and author of award-winning papers, this new course will give an overview of CDISC standards: ODM, SDTM, ADaM and Define.XML. Students will learn how to transform legacy data into these clinical standards through real-life examples. Case studies will include data exchange, archival, and electronic submission to regulatory agencies such as the FDA.
Clinovo will continue to offer the “Base Clinical SAS Programming” class to help entry-level programmers prepare the Base SAS certification, as well as the “Advanced Clinical SAS Programming” class to tackle advanced real-world SAS programming challenges. Clinovo offers $50 gift cards for referrals.
More information on the class can be found on clinovo.com/techtrainings.
Olivier Roth launched the TechTrainings by Clinovo in 2012, a series of hands-on courses for clinical trial professionals, leveraging his company’s years of on-field experience and industry expertise. He is the Marketing & Communication Coordinator at Clinovo, a CRO based in Sunnyvale, focused on streamlining clinical trials for life science companies through technology solutions. Olivier helps managing Clinovo’s marketing and communication from marketing strategy to partnership management, lead generation, event planning and new business opportunities. Prior to Clinovo, Olivier was working as a Strategic Marketing Consultant at VivaSante, an international consumer healthcare company based in Paris.
There is a general consensus that the old paper-based data management tools and processes were inefficient and should be optimized. Electronic Data Capture has transformed the process of clinical trials data collection from a paper-based Case Report Form (CRF) process (paper-based) to an electronic-based CRF process (edc process).
In an attempt to optimize the process of collecting and cleaning clinical data, the Clinical Data Interchange Standards Consortium (CDISC), has developed standards that span the research spectrum from preclinical through postmarketing studies, including regulatory submission. These standards primarily focus on definitions of electronic data, the mechanisms for transmitting them, and, to a limited degree, related documents, such as the protocol. Read more »
Austin, TX – 18 April 2012 – The Clinical Data Interchange Standards Consortium (CDISC) is pleased to announce today at the CDISC European Interchange Conference in Stockholm, Sweden, the release of the first iteration of a Protocol Representation “Toolkit” for clinical research. The purpose is to make it easy for authors of the research plan or protocol to reap the benefits of the Protocol Representation Model (PRM), which has been developed over the past decade by global clinical research experts from academia, industry and government. Using such a model can save time and resources for research studies by enabling electronic re-use of protocol information for other purposes such as clinical trial registration, study tracking, regulatory information and study reports. The current release of the “Toolkit” includes a standard Study Outline Template in MS Word format, a standard list of Study Outline Concepts, and a complete mapping of the Study Outline Concepts to both the Biomedical Research Integrated Domain Group (BRIDG) model and the CDISC Study Data Tabulation Model (SDTM) Trial Summary (TS) Domain. Read more »
Here is the second part of ‘Dive into CDISC Express’, written by Jiangtang Hu. You can read the first part here.
Step 1 of 6: Create a new study (create_new_study.sas)
Open create_new_study.sas in C:\Program Files\CDISC Express\programs\, you can see only one line of a macro call:
%addnewstudy(studyname=my new study);
Just assign a study name to the macro variable, &studyname, e.g, “CLINCAP”:
Submit the codes, you can find a folder named “CLINCAP” with the same structure as the two demo studies imbedded in this application(example1 and example2) in C:\Program Files\CDISC Express\studies\, see(the left and right panels are folders and files before and after the execution of create_new_study.sas. The following the same):
Folder ‘doc’ is used to hold the mapping files;
Folder ‘log’ used to hold log files generated by following macro calls, such as generate SDTM domains;
Folder ‘results’ and its subfolder will hold all the outputs, such as define.xml, SAS transport file, validation reports and SDTM datasets;
Folder ‘source’ holds all the clinical raw data used as inputs for SDTM domains;
Folder ‘tempdata’ holds all the temporary datasets generated by following macro calls.
Also, a configuration file named CLINCAP_configuration.sas put in C:\Program Files\CDISC Express\programs\study configuration\. This file is used to set some study level parameters, such as lab and toxicity specifications (details in C:\Program Files\CDISC Express\specs\Lab specs\).
Two versions of SDTM implementation guides are supported by CDISC Express, CDISC SDTM Implementation Guide Version 3.1.1 and Version 3.1.2. You can find the corresponding specification files in C:\Program Files\CDISC Express\specs\SDTM specs\:
The choosing of SDTM implementation version is also coded in the configuration file, in Line 41:
Version 3.1.1 is used by default. You can also choose Version 3.1.2 if needed:
Assign a study name and choose a SDTM implementation version. That’s all needed in step 1. Let’s take few minutes to navigate the software. CDISC Express is a set of macros and Excel files. It is important to know the file structure.
C:\Program Files\CDISC Express\
├─documentation : FAQ, Quick Start, User Guide
│ ├─ClinMap : system level macros
│ └─function_library : study level macros
├─programs : “action taken” macros
│ ├─study configuration : study parameters configuration, e.g, choose SDTM version
├─SDTM Validation : For validation of SDTM domains
├─specs : specification files
│ ├─Excel engine : ExcelXP tagset file
│ ├─Lab specs : lab and toxicity
│ ├─Mapping validation : validation rules
│ ├─SDTM specs : hold two versions of SDTM implementation
│ └─SDTM Terminology : SDTM codelist(including NCI terminology)
└─temp : hold temporary data not specified to any studies
As we already got, all the “action taken” programs such as create_new_study.sas are located in C:\Program Files\CDISC Express\programs\. In create_new_study.sas, one macro is called, %addnewstudy, which is in C:\Program Files\CDISC Express\macros\ClinMap\.
Note that in C:\Program Files\CDISC Express\macros\, there are two sets of macros in different folders:
C:\Program Files\CDISC Express\macros\ClinMap\: this folder holds all “system” level macros used by the application only. No modification encouraged.
C:\Program Files\CDISC Express\macros\function_library\: macros used for mapping among studies. You can also create you own macro in this folder. The application imbedded macros also documented in user guide.
Next part on the mapping file next week!
Stephen Chan and I have just presented CDISC Express at PharmaSUG 2011.
CDISC Express automatically converts clinical data into CDISC SDTM.
It is free CDISC SDTM mapping tool based on SAS macros and using an Excel framework. All the code is available and can be changed.
I have been working on this application over months now. I have already gathered some very interesting feedback at SUGI 2011 after my paper presentation. It would be great to have other SAS programmers test it and play with it.
You can download it here : http://www.clinovo.com/cdisc/download
Looking forward to your comments
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