Best Practices 1.

Batch Management ============== It is recommended as best practice to retain the required Batch IDs with details and delete the previous Batch IDs, which are considered as draft versions. It is recommended to keep only the required batch outputs and delete the unnecessary batches 2. Data Extraction Group ================ It is recommended as a best practice to perform data cleansing of extracted data based on study needs when extractions are done within a period of time. It is advised to check the options export to excel, contents, and print if and only if it is required by business so as to avoid unnecessary information being stored in the file server. It is recommended as a best practice to generate the SMDR comparison report, if the extraction is performed after any amendment has take place in the protocol document, which has lead to amendment of CRF and data capture. Select the following options only when required Perform data cleansing when re-extraction is being done Export to Excel format Contents Print
dataset

when the user needs to extract the data in excel When the user wants to Show the contents of

a dataset and print the directory of the SAS data library.

when it is required to print the observations in a SAS

SMDR Comparison report when the user wants to generate

comparison report between most recently extracted versions against the previous extraction

3. Data Derivation Group ================

It is advised to check the option Export to Excel, if and only if it is required by business so as to avoid unnecessary information being stored in the file server. Select the following option only when required Export to Excel
datasets in.xls format

when the user needs to extract the derived

4. Report Program Group ================ It is recommended as a best practice to select the report format for analysis & report generation Select the following options only when required Report Generation when the user want to Generate the TFL report with actual dataset values Mockup Generation when the user want to Generate the TFL report with mockup values Export to Excel when the user needs to extract the intermediate
datasets in .xls format

CDISC Conversion Group

It is advised to check the options Export to ODM File, Include printable PDF generation (define.xml), and Export to Excel if and only if it is required by business so as to avoid unnecessary information being stored in the file server. Conversion Output options
Export to Excel: Select this option only when the user wants to convert the converted datasets in .xls format

For SDTM, select the following options only when required Export ODM File When it is required to export the generated output as
ODM file

Include printable PDF generation (define.xml) When it is required to convert the generated output as a PDF Delete missing observations required variables when the user wants to delete the missing value observations for required variables in the
generated output

SUPPQUAL is required as separate dataset for each domain when the user wants to have separate datasets for SUPPQUAL datasets Delete missing observation for QVAL when the user wants to delete the
QVAL in the generated output

Include RELREC when the user wants to include RELREC configuration for conversion

For ADaM, select the following options only when required It is advised to check the options Export to ODM File, Include printable PDF generation (define.xml), if and only if it is required by business so as to avoid unnecessary information being stored in the file server. Export ODM File When it is required to export the generated output as
ODM file

Include printable PDF generation (define.xml) When it is required to convert the generated output as a PDF Delete missing observations required variables when the user wants to delete the missing value observations for required variables in the
generated output

Validation Compliance options It is advised to check the options and recommended as best practice Variable Compliance Report,

 SDTM Dataset Validation Report (based on FDA, JANUS), define.xml Structural Validation Report, Validate Schema, define.xml and XPT Comparison Report Conversion Specification Report, and XPT vs Dataset Comparison Report, if and only if it is required by business so as to avoid unnecessary information being stored in the file server For SDTM, select the following options only when required Variable Compliance Report when the user wants to generate a compliance report as a result of comparison between the CDISC SDTM/ADaM standard
datasets and the generated output dataset.

SDTM Dataset Validation Report (based on FDA, JANUS) when the user wants to generate SDTM dataset rules validation report based on FDA and
JANUS

define.xml Structural Validation Report When the user wants to generate compliance report based on the following o Domain compliance o Variable Compliance o Value List compliance o Computation Algorithms o Controlled terminologies Validate Schema When the user wants to generate the log by validating
the schema of the generated define.xml

define.xml and XPT Comparison Report When the user wants to generate
the define.xml and XPT Comparison Report by comparing the XPT and generated define.xml.

Conversion Specification Report When the user wants to generate conversion specification Report for the following sections o o o o o Domain Level Metadata Mapping Report Value Lists Computational Algorithms Controlled Terminology

XPT vs Dataset Comparison Report when the user wants to generate a

comparison report between the generated SAS dataset and XPT

For ADaM, select the following options only when required It is advised to check the options and recommended as best practice Variable Compliance Report, ADaM/Custom Dataset Validation Report define.xml Structural Validation Report, Validate Schema, define.xml and XPT Comparison Report Conversion Specification Report, and XPT vs Dataset Comparison Report, if and only if it is required by business so as to avoid unnecessary information being stored in the file server Variable Compliance Report when the user wants to generate a compliance report as a result of comparison between the CDISC SDTM/ADaM standard
datasets and the generated output dataset.

ADaM/Custom Dataset Validation Report when the user wants to

generate ADaM dataset rules validation report based on CDISC.

define.xml Structural Validation Report When the user wants to generate compliance report based on the following o Domain compliance o Variable Compliance o Value List compliance o Computation Algorithms o Controlled terminologies Validate Schema When the user wants to generate the log by validating
the schema of the generated define.xml

define.xml and XPT Comparison Report When the user wants to generate
the define.xml and XPT Comparison Report by comparing the XPT and generated define.xml.

Conversion Specification Report When the user wants to generate conversion specification Report for the following sections o o o o o Domain Level Metadata Mapping Report Value Lists Computational Algorithms Controlled Terminology

XPT vs Dataset Comparison Report when the user wants to generate a

comparison report between the generated SAS dataset and XPT

BioStats BioStat module of iDERT aids the statisticians in the process of examining data to draw conclusions or insights, and determine cause-and-effect patterns between events; for example determining the safety and efficacy of new drugs by drawing out a probability as to whether the fact that a patient got better (or worse) was due to the drug or some other (perhaps random) factor. BioStat module supports different analysis requirements as laid out by regulatory ranging from DSMB submissions to Analysis of Integrated Safety and Efficacy analysis. iDERT facilitates the statisticians to perform the analysis & reporting activity even before the study is conducted by way of extracting the dummy datasets from the data capture systems with zero observations i.e. where no data is captured at that point of time, with the objective to do activities in parallel and making use of the automation facility available in iDERT. iDERT's BioStat module adopts a process whereby the reports are generated based on mockups only. That means, a mockup should be designed and reviewed before the generation of reports. It ensure one of the key best practices of report generation where the mockup was reviewed before any generation activity as per SAP and any adhoc analysis requirements. TFLs generation is vital for the Biostatisticians, Medical Writers and other stake holders to review the data that is captured during the trial. There can be data captured during the study and might require to be submitted to IRB as part of DSMB Shells. This is optional and depends upon Study and Sponsor initiatives. On the other hand, generation of TFLs is required for the Biostatisticians to start working on the analysis and reporting as per the approved Protocol and SAP. iDERT offers features to users to generate the TFLs based on the mockups or independently generate TFLs by creating new definitions. It is advised to check the options and recommended as best practice Variable Compliance Report, ADaM/Custom Dataset Validation Report define.xml Structural Validation Report, Validate Schema, define.xml and XPT Comparison Report Conversion Specification Report, and XPT vs Dataset Comparison Report, if and only if it is required by business so as to avoid unnecessary information being stored in the file server Tables

When generating Tables it is advised to select the RTF option for the output report types in Program Info tab Figures When generating Figures it is advised to select the RTF option for the output report types in Program Info tab Listings When generating Listings it is advised to select the RTF option for the output report types in Program Info tab Data Management Analyst The transpose functionality comes in hand for SAS Programmers and Biostatistician to get the Datasets in the required structure. Users of IDERT should be familiar with the usage of ByVar, Var, IDVar to do the transpose. SDTM It is recommended to prepare a draft specification of mapping that needs to be done as part of the SDTM conversion activity before a user logs into iDERT to perform the mapping of source to target variables. Missing: Limitation What cannot be done in SDTM mapping Before initiating the data mapping and conversion process it is crucial to have a basic understanding of the SDTM specifications. CDISC provides implementation guide for all the CDISC SDTM data standards on their Website (http://www.cdisc.org/standards/index.html). The SDTM Implementation Guide is an essential tool for anyone involved with the metadata mapping or programming associated with the creation of SDTM data sets. ADaM Missing: Limitation What can be done ADaM but not in SDTM mapping? CDISC Analysis Data Model (ADaM) defines a standard for AD's to be submitted to the regulatory agency. In most implementations, the AD's contain variables from multiple SDTM Domains and contain derived variables for specific analyses. In ADaM, the descriptions of the AD's build on the nomenclature of the SDTM with the addition of attributes, variables and data structures needed for statistical analyses. Batch Exceptions

This section gives a brief description of the User defined message codes that are handled by the SAS BATCH Macros. Batch Message Codes is classified based on the SAS BATCH Macro Classification. The errors are presented in this document as General and Process Specific Error Codes. General Message Codes are handled by the Main Batch macro, which handled the overall macro calling management. Macros are classified into Derivation, Analysis, Utility, Exception, Interfacing, Main, Conversion, Extraction, Reporting and the message error codes are presented in this order. These messages are presented to the user in different types such as Notes, Information, Warnings and Errors. These are available in the IDERT SAS Log files. Message Format: The Format of the header information is as follows: <TYPE> <CODE> : <ISODATE> <ERR-MESSAGE> TYPE : Specifies the Type of the Message namely UERROR, UWARNING, UNOTE CODE : Represents the specific code to identify where the error has occurred like in which macro & module ISODATE : Specifies the month, day, year , time at which the Exception thrown ERR-MESSAGE : Specifies the Exception message Eg. UERROR U405-0192: '2007-10-29 20:12:39' No observations found in the dataset trptdefds

Manage Mockups (Global and Sponsor)

Mockup creation is one of the initial set of activities that is required to be completed as part of the Statistical Analysis Plan (SAP) Development. Biostatisticians work on the mockup creation based on the requirement of the SAP and finalize the same after multiple reviews. iDERT is loaded with predefined set of Mockups for the use of Biostatisticians in their regular day to day work.

The newly defined TFLs can also be promoted to the Global Library of Mockup after its successful generation at the discretion of Users Users are also provided with additional feature of retiring the mockups, if it is not going to be used in future or the company has decided to do away with the mockup.

An open bracket must be closed; otherwise SAS will treat it as an error and flash an ERROR message. Do not use quotes. Select Format (if needed). Format is applicable for categorical variables only. Select case to convert case in the character variable value. Convert Case not applicable for format variables. The available cases are o UPPER CASE o lower case o Title Case o Sentence case Select the required order of analysis variables using drag and drop option. Based on the order selected the output report will be displayed. Check Report Display Variable if the you need to display the variable in the report. It is applicable only for By Variable, Page-By Variable and Analysis Variables. Check Analysis Variable, if you need to use this variable for statistical calculation. The last step in the Data Derivation screen should be PROC SORT or DATA step Do not use DATA _NULL_ or any comments in the last step.

User cannot provide column header for By Variable and Page-By Variable(s) in column header screen whereas it will take Report Display Label in Variable Definition screen as a column header. If you select Statistics Type as Actual Data, you cannot add column header but to proceed the process provide blank column header. Its other column header will be taken from Variable Definition screen which are provided as Report Display Label.

User can provide superscript values by ^{super xxx} User can provide | for split two column headers.

How Do I

This section will help the Users of iDERT to train themselves in working with various Business Cycles provided. Each of the sections gives information on 'How to proceed' with the operation of each cycle.