Study Archive

Sponsors may find it difficult to imagine that one study archive is truly different than those provided in other eClinical systems. PHT's study archive, however, is unique in that it contains the actual eSource XML data collected by PHT's ePRO Product Suite - complete with audit trails, screen shots and signatures - in addition to the scanned PDFs representing the data which comprise other archives in the industry. PHT's Study Archive meets and exceeds current regulatory requirements for data retention and trial reconstruction.

Begin with the End in Mind

The study archive is often far from the mind of clinical project managers eager to kickoff a new study. However, the ultimate deliverable of any trial is a secure and persistent store of the data collected. As the final record of your trial, and often of your primary endpoint data, it makes sense to consider your archive when designing your study.

Key Benefits of Our XML Archive

• Data Retention - XML data will always be human readable, even if current technical formats and applications (i.e. PDFs) change
• Contextual Data - Audit trails, screen shots and signatures provide for trial reconstruction
• Reliability - Because the data cannot be modified, the archive is tamper-proof and allows for confirmation of validity
• Standards - XML is the basis for the CDISC format, which lends itself to standardization and integration into other eClinical software and systems
• Data Mining - With XML, you can perform data mining across studies.
• Original eSource - XML is the actual eSource data, and will always meet regulations.

Passing Site Inspection

Upon trial closeout, PHT provides sites and sponsors with permission-based archives delivered on special durable CD-ROM and DVD-ROM media. PHT occasionally receives calls from investigator sites preparing for their FDA audits. PHT's expert Study Support Center is available to train sites on how to make the most of their Study Archive, and the response has been overwhelmingly positive. Most importantly, there have been no issues raised from any FDA or other regulatory audits with regards to PHT's ePRO systems.

Learn More about the Archive

Why doesn't everyone use an XML? How can the data on the archive be used in my submission? Contact PHT for answers to these questions or any others you may have.