Did you know that SEND Explorer can be used to load both final datasets for completed studies as well as interim datasets for studies that are still in progress? Here's all the details on how to use SEND Explorer to analyze and visualize data from studies that are in progress.
Collected data for studies that are in progress can come in a variety of formats. If studies are being conducted at CROs, the most frequently used formats used for interim data are SAS XPT (same format used for final SEND datasets) and Excel. For studies conducted internally by sponsors, most data for ongoing studies are housed in the data collection system (e.g. Pristima) used by the sponsor.
SAS XPT Format for Interim Data
SEND Explorer Standard and Plus are both limited to only loading data in SAS XPT format. This means that for interim study data. the dataset files need to come in as SAS XPT files that look almost identical to those provided for final submission datasets. The difference between these interim datasets and final submission datasets in SAS XPT format is that the interim datasets will only include data collected up to the time they were created, may not have all required controlled terminology applied and may not have all the SEND metadata fields populated. Many CROs have the ability to output interim SEND datasets using the same systems used for producing the final datasets, so producing interim datasets in SAS XPT format can be done quickly and easily. CROs will work with sponsors to determine a schedule for delivery of the interim datasets (e.g. daily, weekly monthly, at specific study milestones, etc.) and there may be a per dataset charge. Certara recommends negotiating the details around interim data delivery at the time of study initiation, if possible.
Interim SAS XPT datasets included in zip files with no password protection can be loaded into SEND Explorer Standard, Plus and Warehouse for single study data analysis and visualization. SEND Explorer Plus and Warehouse both include databases, so interim SAS XPT datasets can be loaded to the database and replaced with updated or final datasets as they are received. Interim data loaded into SEND Explorer can then be reviewed for just a single study or across programs, drug class, etc. using cross-study analysis and visualization features.
Excel and Direct Database Connection for Interim Data
SEND Explorer Warehouse supports loading of interim data in CRL Apollo and SEND XLSX formats (as well as SAS XPT), direct connection to the Pristima data collection system and outputs from other data collection systems. CRL Apollo and SEND XLSX connectors come standard with SEND Explorer Warehouse, but there is typically a setup and configuration charge for direct data collection system connections as many sponsors use systems differently. SEND Explorer Warehouse also allows studies in CRL Apollo and SEND XLSX formats as well as output from data collection systems to be loaded in batch through automated feeds that can be done on demand or scheduled for off hours.
More Questions?
Please contact Peggy Zorn, peggy.zorn@certara.com if you have additional questions or would like to discuss using your SEND Explorer environment with interim study data.