While the eBinders and site-based regulatory documents comprise the investigator’s trial master file (TMF). TheraScan also supports the collection and maintenance of the sponsor’s portion of the TMF.
In most cases it is a best practice to segregate documents generated or held by the sponsor of the trial from those of the investigator. This requirement is primarily due to subject confidentiality issues, in that the sponsor must not have documents such as consent forms and subject identification lists if the subject has not specifically consented to them holding this information. Secondarily, where the investigator site file contains source documents, the case report forms (CRFs) contain source data or the CRFs are the investigator’s independent copy of the transcribed data, providing this to the sponsor would remove the investigator’s control.
The HIPAA-compliance of TheraScan allows for the existence of the investigator documents to be monitored, even while protecting the content of the document from review by a sponsor or lead investigator. Metadata, which does not include protected health information (PHI), is used to categorize and track individual document. The content of the documents, which is stored in the database as a binary object, is not viewable except by the originating site, the appropriate monitor, or by specified clinicians in the event of a severe adverse event.
The TMF Reference Model is typically used as the organizational template in TheraScan. This provides consistency of implementation across multiple studies. Plus, this simplifies the submission of the TMF to the regulator. TheraScan supports the RDF/XML format defined by the OASIS eTMF specification.
TheraScan stores multiple versions of a document. In one implementation this allows for a point-in-time review of a document, such as a protocol, that might change over the course of the study. In addition, site-specific documents can also be maintained in the TheraScan system. An example would be an study informed consent, which needs to have a site-specific version due to constraints place by the local institutional review board (IRB).
TheraScan is also used a a repository of current documents that can be accessed by users during the trial. This means that a site can access the protocol, guaranteed that it is the most current version, without have the responsibility of keeping study documents current at the site level.