One of our biopharm clients that uses our clinical data management software, recently tried to share SAS data files with the biostats department…a pretty common requirement these days.
When the biostatistician tried opening the file, they received the following error:
Error when trying to read the file:
ERROR: Invalid or missing READ password on member TRTDATA.CM.DATA
Error when trying to remove the password to put dataset on our system:
ERROR: File TRTDATA.AE cannot be updated because its encoding does not match the session encoding or
the file is in a format native to another host, such as WINDOWS_64.
In this instance, the data manager is using a server that is a 64-bit machine, where SAS stores the tables differently. The statistician has a 32-bit machine. SAS allows access to the tables directly for read purposes, but unfortunately, not for updating. Accordingly, the log window (above) tells that the file is native to another host “such as WINDOWS_64.
In this situation, you cannot use a SAS format catalog (formats.sas7bcat) in another environment.
The way this is normally dealt with is by using what is called a SAS Transport File, which is like SAS’s version of a zip file. This will place all of the data into one file that can then be delivered to the intended party. They will then need to extract these files using SAS. SAS transport files also allow the passing of format catalogs across environments.
In the screenshot below I opened a table exported from 64 bit version and opened it with a 32 bit version of SAS. The table has Read Write and Alter passwords applied to it.
Group: Northeast Clinical Programmers and Biostatisticians
Are you spending too much time custom programming to achieve the desired results for tables and listings? Our all new Report template library saves time and frustration.
Comment: Vendors tools such as ClinPlus for creating tables and listings are too expensive for sponsors on a long-term basis, and as such not worth for spending so much budget. Major pharmaceutical companies like Pfizer, BMS, Novartis, GSK, Bayer, and many others have developed a set of macros which are more friendly and easy to use. Vijay Chauhan Owner, Alpha Stats Inc and Pharmaceuticals Consultant
Response: Actually, embarking on a standard reporting system development project using in-house programmers typically costs 5-10 times what ClinPlus licensing fees would cost, perhaps much more if using third party consulting companies. And, results are uncertain at best. I have seen several of these projects fall well short of their initial goals or fail completely - money down the drain. With an off the shelf product like ClinPlus Report, that has been in production (with ongoing development) for 20+ years, companies see the benefits immediately and have a team of experts available to support them.
Many of the pharmaceutical companies you mentioned do, in fact, use ClinPlus as their standard along with several other tier-1 pharmas, biotechs and CRO's. (60+ ClinPlus clients total) All have expressed satisfaction in not only the time and money saved but also in the superior quality and flexibility they enjoy from a validated, expertly supported product. The return on investment with this product is predictably significant vs. any development effort with an unknown final outcome.
VP Product Devlopment and Programming
DZS Software Solutions, Inc.
Check out this page http://www.linkedin.com/redirect?url=http%3A%2F%2Fwww%2Eclinplus%2Ecom%2Fproducts%2Freport-template-library-authoring-tales-and-listings%2F&urlhash=VAeQ
Choosing the wrong report software for your organization could be a career ender, especially if your organization is in the Life Sciences arena where drug safety and time-to-market are everything.
Here's a few questions to consider asking before you decide. We've also included a link to a complete list of qualifying questions.
Below is a typical clinical data demographic table that is needed when compiling a final clinical study report. In order to complete a table like this, a SAS programmer could spend hours or days to get all the text to line up correctly so analysis and review can be done more easily.
Q1. Will your software run in my existing computer environment?
Reason for asking:
You should first determine if your operating system is supported and your computers adequate.
The ClinPlus Report Engine can be installed under any operating system that supports SAS. Current installations include Windows and, Unix. The Report GUI is installed in a Windows environment. A hybrid installation is supported via SAS/CONNECT where the Report GUI resides under Windows and the Report Engine resides under Unix.
Q2. What programming language is your system written in?
Reason for asking:
To determine if the system complies with company standards and will easily integrate with existing systems and procedures.
ClinPlus Report is written in SAS, the industry standard in clinical data analysis. The current version is validated under SAS v9.1.3 and 9.2.
Q3. Is your system a collection of programs written to produce pre-defined reports or a tool used to create custom reports?
Reason for asking:
To ascertain overall system philosophy and to get a general impression of flexibility.
ClinPlus Report is not merely a report selector, rather a true report authoring tool. With this tool, users can create custom reports with the content and layout they require. These report templates can then be saved in libraries for future use. However, DZS does offer a complete library of safety table and listing templates that can be customized to your unique standards.
Q4. What type of reports can be created?
Reason for asking:
To determine the scope of the system. Ask about various statistical and summary tables, data listings, patient profiles, etc.
ClinPlus Report produces presentation quality statistical tables, data listings and patient profiles.
Q5. How is the system accessed, through programing, interactively (GUI), or both?
Reason for asking:
To get an idea of the range of skill sets required and integration possibilities.
The system is used either through an intuitive GUI interface or by programming. Furthermore, programs can be created using the GUI?
These are just some of the basic question to ask.
For a more comprehensive list of questions and answers regarding the selection of the right authoring tool for clinical trial data analysis and the efficient production of statistical tables and listings please visit our website: http://www.clinplus.com/products/report/reports-specific-questions/
ClinPlus Report's unmatched flexibility puts you in control and saves your team valuable SAS programming time. ClinPlus Report gives you complete control over:
Wondering how you can effectively meet the clinical data study standards set out by the Clinical Data Interchange Standards Consortium (CDISC), specifically regarding the Study Data Tabulation Module (in a process also known as SDTM mapping) and the Analysis Data Model (ADaM)? Then our data conversion and reporting tool may be the solution for which you’ve been looking. Imagine being able to generate all of your safety tables and listings, and provide supporting documentation in a validated, standardized ADaM-compliant manner. Now you can.
Adhering to CDISC standards has proven to facilitate efficient data integration and transport, as well as access and review. Ideally, FDA Reviewers will want to perform analytic review using ADaM standards. However, converting your SDTM mapping data to ADaM data, to submission-ready tables, and then accurately documenting the process can present numerous challenges.
One of the primary challenges is providing complete documentation of the creation of the tables and listings, and the underlying ADaM data sets, the process by which each variable in the ADaM is traced back to its original source. CDISC specifications indicate that any variables copied or derived from an SDTM domain into an ADaM data set must retain the integrity of the data in the SDTM domain.
The ClinPlus Solution
ClinPlus has developed an elegant solution for metadata driven conversion of SDTM mapping data to ADaM data, and then produces metadata parameterized- driven flexible safety tables and listings from the ADaM data. The metadata defined in Microsoft Excel spreadsheets becomes the ADaM documentation, thereby eliminating any chance that documentation might not correspond to the actual process.
The first step is to convert your SDTM data to your ADaM data using the ClinPlus Data Converter Method. The ClinPlus Data Converter Method is controlled by metadata stored in Microsoft Excel spreadsheets that define how SDTM mapping data are written into ADaM data structures in an Excel worksheet for each data domain. A data conversion rule is specified for each variable. These conversion rules are written using Base SAS programming syntax that is submitted to SAS during the conversion process. A cross-reference to Statistical Analysis Plan documents the rational for each conversion or derivation. This method provides clean, exact documentation of the process, as well as simple maintenance and versioning. This approach not only documents a complicated process, but maintains the data integrity between the SDTM and ADaM data sets, thus meeting CDISC specifications.