file systems have different limits on the depth of the filename path, creating potential problems and limitations based on the file system hierarchy in use.[10] Thirdly, with respect to the use of the TMF Reference Model as a database schema, the TMF RM v3.0 spreadsheet cannot be used without manual modification as a classification taxonomy in an electronic database.[11] Electronic systems which are not based on interoperability standards are often unable to communicate with other systems or applications.[12] The TMF RM currently lacks a controlled vocabulary based on published standards, which means that content indexed with the TMF RM artifact names and terms could return duplicate records, incorrect records or possibly no records at all if the model is not implemented appropriately.[13]The TMF RM doesn't provide standards-based methods to exchange the TMF model except for exchanging spreadsheet copies of TMF models. Today internet standards such as those promoted by the W3C are utilized for interoperable electronic exchange over legacy manual information exchange approaches. Development of eTMF Content Exchange Standards and Protocols In an effort to assure interoperability of eTMF data among clinical trial stakeholders, in September 2013 non-profit CareLex initiated an eTMF standards initiative under the OASIS Open standards development organization for the development of a global eTMF ISO standard supporting seamless eTMF content exchange and portability. CareLex and SureClinical Inc are the founding sponsors of the eTMF standards initiative, with participation on the curation of a controlled vocabulary by the National Cancer Institute. The stated objective of the eTMF standards initiative is to "define an open, internationally recognized standard that will assure information interoperability among clinical trial stakeholders in the BioPharma industry." According to minutes from the OASIS eTMF standard Technical Committee, the standards initiative is coordinating the efforts of clinical trial sponsors, CRO’s, research organizations, and vendors to develop an ISO standard. This effort did not receive industry support and has now been dismantled and replaced by the TMF Reference Model Exchange Mechanism. As of February 2014, a partial list of members in the OASIS eTMF Standard Technical Committee includes CareLex, EMC, Forte Research, HL7, Mayo Clinic, Oracle, Paragon Solutions, Safe-BioPharma, SterlingBio, and SureClinical. National Cancer Institute worked with the OASIS team to curate eTMF terms. The Technical Committee was closed by TC Administration without publication of a standard on 17 November 2017 and is no longer active. In June 2018, the TMF Reference Model project team published