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Roll Call – Members and Observers Present (alpha order)Michael Agard, Paragon Solutions; Jennifer Alpert Palchak, CareLex; Aliaa Badr, CareLex; Lou Chappuie, individual; Sharon Elcombe, Mayo Clinic; Chet Ensign, Oasis; Troy Jacobson, Forte Research Systems; Rich Lustig, Oracle Health Sciences; Alex Palinkash, CareLex; Eldin Rammell, Rammell Consulting; Fran Ross, Paragon Solutions; Catherine Schmidt, Sterling Bio; Zack Schmidt, SureClinical; Stephen Scribner, EMC; Mead Walker, HL7. (Leave of Absence – Peter Alterman)Approval of MinutesMotion: Lou moved to accept the February 3 minutes, the motion was seconded by Catherine and the minutes were unanimously approved. Policy Review. Chet noted that the roles Member and Observer status are governed by Oasis policies. Go to Oasis, Resources Section 1 Definitions for more details. A Member is allowed to participate and make contributions to the TC. In contrast, an Observer may subscribe to the TC, but is not allowed to participate or make contributions. The Observer role was created for those who want to follow the activities of the TC, but are not prepared to be governed by the Oasis IPR policies of the TC. When you join the TC as a Member, your organization must review and agree to be bound by the IPR policies of Oasis. Observers are not bound by the IPR policies, so they cannot be engaged with the TC. Observers are listed on the roster and minutes which are visible to the TC, but Observers are not listed and visible for public view. Mead stated he assumed that he’s a non-voting member and represents HL7. Chet verified that Mead is a Member on the roster, and indicated that each member can choose to be a persistent non-voting member, if they wish, but as a member he can obtain voting rights and vote. It is each member’s decision.Zack brought up the request by Eldin Rammell, Steve Scribner, and Karen Redding of the TMF Reference Model Steering Committee to change the TC name. Chet stated we should first discuss due to the ramifications. Oasis policies—specifically Section 2.12, called TC Rechartering—states there are two things the TC may not change; the TC may not change the TC Name or the IPR Mode of TC. In order to change either of these, the TC must close down and restart under a new Charter. Eldin stated for clarification that due to statements in Section 2.11, they were under the incorrect understanding that ‘clarification’ would permit renaming. Eldin and Steve stated that based upon Oasis’ explanation, Eldin and Steve wish to drop the recommendation to change the TC name Roll CallJennifer conducted roll call at Zack’s request. Zack noted that Peter Alterman has requested a Leave of Absence from the TC through March 3.Technology Overview: Content Classification LayerZack reviewed the Content Classification Layer discussion the TC has had over the last two meetings and addressed some metadata items brought up at last meeting. The Content Classification Layer is broken into three components; a Classification component for classifying content, a metadata component and a Content Model component. The Content Model helps to classify the clinical trial hierarchy taxonomy in a formally published semantic web ontology (W3C OWL2 language) which uses RDF/XML. Other organizations are also moving to this semantic web model, which further enables interoperability between content models. For example, say the CTMS model follows BRIDG semantic web model, then the eTMF can be more readily integrated with the CTMS for interoperability given they are both based upon the semantic web model. Metadata is used to characterize content, helps us find content items and is tagged onto content items. Documents or content will be tagged with Core (required) metadata and may have optional metadata. Metadata terms are sourced from standards organizations using controlled vocabulary such as W3C, IETF, ISO, NCIt, FDA, CDISC, HL7, secondary sources are Dublin Core and Dicom. Industry sources such as CareLex and TMF RM can also be useful. eTMF-specific metadata will be discussed in Phase II of Charter. Required (Core) metadata are denoted by a red asterisk in the slides and are metadata that must have a data value. For the purposes of our model, Core metadata are the terms associated with the file properties, for audit trail, classification information, organization/person information and business process management. Every content item must have a data value for each required metadata term. There is also some core metadata around business processes and digital signatures. The goal is to enable the terms in the eTMF Standard to have some interoperability with other models such as BRIDG and other groups. Last meeting, we had a discussion about the term ‘Created By’. Aliaa notes she has not discovered any conflicts in researching the term. Eldin had suggested Creator, however Zack noted the definition does not include the notion of username as the term ‘Created By’ does. Username information is important for tracking changes to content in the eTMF.In the eTMF metadata class, there were a couple of terms that the TC discussed that should be associated with every content item. Of eTMF metadata, only two or three terms (Country, Study ID, Sponsor) are being considered for inclusion as core/required since they must be associated with every document/content item in every instance. The group later took up the decision on which of these eTMF terms should be included with every content item. Except for these three eTMF domain metadata terms, Zack mentioned that we will be addressing all other eTMF metadata and domain classification terms in Phase 2, per the TC charter.Content Model Format Naming – Zack noted that with the RDF/XML approach, we can exchange content, metadata, etc. We would like to use naming that follows IETF URL, using alphanumeric characters and special characters limited to hyphens only, to ensure compatibility with downstream applications and standards such as eCTD and HL7-RPSHow Content Models Are Used - A Content Model helps to classify the eTMF hierarchy and establish an ontology, in other words, a structured hierarchy that allows for integration with other structured hierarchies, such as integrating an eTMF into a RDF-based CTMS ontology. There are two components of the content model; the Structure (ontology) and the set of Controlled Vocabulary. Our standard being proposed provides rules for classification AND provides rules and policies for organizations to follow in order to add, delete or modify their own classifications, thus providing great flexibility to organizations. Many other organizations are moving to this approach, including CDISC, FDA/PhUSE, HL7 and others.Content Model Format Exchange – Our model does not dictate a specific exchange protocol for exchange of RDF/XML. Exchange can be done using protocols such as W3C http, REST, SOAP, CMIS, HL7 RPS, or whatever protocol is desired by the implementing organization, thus providing flexibility at the application level. Standardization with Flexibility - Zack reiterated the value of providing organizations with a standard as well as the flexibility to adapt elements of the standard to their own use, within a set of defined rules and policies. Standards allow organizations to and exchange information seamlessly between systems and other models, lowering costs for organizations and simplifying integration tasks for companies deploying eTMF applications and systems. With the use of open technology standards such as W3C RDF/XML and OWL, organizations gain complete interoperability so content models can be exchanged along with metadata. Organizations will not follow a standard unless there are clear guidelines, rules, and policies and also flexibility. The proposed model allows organizations both a standards-based architecture and a standards-based controlled vocabulary, classification model and ontology, as well as a clear set of rules and policies for adding organization specific classifications and metadata. Content Model Versioning - Zack thanked Michael for bringing up the need for version tracking in general. Being a W3C standard, the eTMF Content Model has a built-in element for content model versioning. The W3C OWL specification supports versioning with the versionInfo tag, which allows version management applications to hook into the OASIS eTMF Standard content model, if desired. Zack recommended we publish our specification following the versionInfo tag guidelines. Thus, the first OASIS eTMF Standard content model version would be published as version 1.0. While version management is really an application task beyond the scope of this project and this charter, the TC may wish to consider making the above recommendation. Document Versioning - Zack proposed our specification recommend use of the HL7 specifications for document versioning, namely Major Version.Minor Version. In MajorVersion.MinorVersion, Major Version indicates a change in the document and can be reflected as 1.0, 2.0, 3.0 etc., whereas minor version indicates changes in metadata for the content/document and are reflected in the digits after the dot: (1.2, 1.3, 1.4 etc.) See slide, “Core Metadata – Document Version Numbering”.Country term - Eldin stated he completely agrees with the approaches discussed thus far, but is not sure about use of Country as a Core term. For example, will it reference Country of the Sponsor, Country of the Study? Steve added that there are some documents are completely independent of a country. Zack asked if we need to have Country as a required metadata item. Fran and Rich agreed that Country should be removed as required (Core) metadata.Motion: Eldin moved that the TC remove the term Country as a required (Core) metadata term, Fran seconded the motion. The motion was unanimously approved.Study ID term - Mead asked what the term Study ID denotes. Does it denote the sponsor-assigned study ID given there are other IDs assigned by the regulatory entities or countries? Mead indicated that description of the field Study ID has to indicate the org that assigned the ID. Steve added sponsors can assign an ID, regulatory agencies can assign IDs, and therefore it should be a flexible field. Eldin suggested that many times eTMFs will have multiple fields to capture the Sponsor assigned study ID, the ID, and others. Zack noted the challenge will be how we should define the Study ID, should it be flexible?Lou suggested we define the Study ID as an organization-specific value and then allow the organization to tag it. Jennifer suggested further defining Sponsor-assigned Study ID for clarity, then for example a ID could be included in the eTMF, along with the ability of the organization to further edit to meet their needs. Mead agreed that description of the Study ID field must clearly indicate the sponsor organization. Rich asked is it fair to say that all trials are initiated by the sponsor? If so he proposes the Study ID is defined as the Sponsor-defined ID, and then we allow additional granular metadata tags. Eldin commented that field should be labeled Sponsor Assigned Study ID.Motion: Rich moved that we amend the definition of Study ID to be ‘a Sponsor-defined series of characters used to define or characterize the study.’ Lou seconded motion. The motion was unanimously approved.Sponsor term - Zack asked the group which term we adopt, Sponsor or Clinical Study Sponsor, and should we set this as a Core term? Troy suggested the intention was to correlate the sponsor with the Study ID. Eldin noted that is it possible to have two sponsors who inadvertently assign the same study ID, thus a separate core metadata term is essential. Eldin noted ICH uses Sponsor and Mead echoed that the term Sponsor seems sufficient. Troy suggested the Sponsor is a primary key and is correlated to the Study ID.Motion: Eldin moved that we adopt the term Sponsor for the entity leading the initiation, funding and oversight of the study and will be a required (Core) data value. The motion was seconded by Fran. Zack qualified it will be a required metadata item which means that every content item in the eTMF archive will be required to have a data value for the term Sponsor. The motion was unanimously approved.Zack reviewed that we have covered the Content Classification Layer with its components and reviewed how this model allows us to work with other ontologies using RDF/XML. He asked for a motion to adopt the Content Classification Layer which would be drafted as in the OASIS eTMF Draft Specification and would then be published, reviewed by the TC and open for review by other organizations, and then we’ll fine tune it from there. Motion: Aliaa moved that we adopt the Content Classification Layer with the Classification Categories component, Core Metadata component, the Content Model component, and the modification rules as noted in the power points and minutes. Lou seconded the motion. Following discussion noted below, the motion was unanimously approved.Discussion - Fran asked for clarification on what exactly will be adopted. Zack stated that the next step will be to take what we’ve adopted and develop a draft specification for others to review and react to. After discussion, Fran indicated that she was clear about what is being proposed. Michael reminded the TC that we need to close out any issues raised on the TC before this motion can be adopted. Michael pointed out that any issues opened and pertinent to this layer need to be closed before we vote on this CC Layer. Jennifer reviewed the issues list and identified two items on the list, Country and Site ID. She noted both of these issues were addressed by the TC today and affirmed all issues can be closed out except for those metadata that must be addressed in Phase II of the Charter since they are eTMF domain specific terms. Zack thanked Michael for bringing up the Issues List items. Outreach CommitteeJennifer welcomed Tom Johnson and Sharon Elcombe of Mayo Clinic as official members of the TC. Shire and New Gen are working through their process for membership. Kaiser Permanente is officially a member but is still identifying who will participate in the TC. Pfizer has inquired about membership. To date we have made 46 contacts at 40 unique organizations.Zack reported that he has been in touch with FDA/PhUSE project members and they are interested in reviewing the OASIS eTMF Standard draft specification. Jennifer added that the EMA is also interested in reviewing the TC’s draft specification when it is ready.New Business No new business was proposed by the group.Proposed Meeting Agenda for 3/3Roll CallApproval of MinutesTech Discussion: Web Standard Technology Layer and digital signaturesOutreach report New BusinessAction Items from this meeting:A. The term Country will be removed from the list of Required metadata of the eTMF Standard. The term is still present but there is no requirement to capture data values for this term for every content item in the eTMF archive.B. The definition of Study ID is defined as “a Sponsor-defined series of characters used to define or characterize the study.” Study ID is a required metadata term for every content item in the eTMF archive. Every content item in the eTMF archive must contain a data value for this term.C. The term Sponsor is defined as “the entity leading the initiation, funding and oversight of the clinical study” and the term Sponsor is included as a Required metadata term for every content item in the eTMF archive. Every content item in the eTMF archive must contain a data value for this term.D. As discussed on February 3, we will wrap up active outreach efforts at the end of February. All TC members are asked to contact prospective members for the TC and may use or alter the documents posted on the Oasis eTMF TC Outreach Subcommittee page to promote participation. Please notify jalpert@ of any contacts made.E. Members with issues for the TC to address are asked to please post them to the eTMF TC Issues List in preparation for meetings.F. Members can forward agenda items to Zack at zs@ .Meeting adjourned at 10:32 a.m. PT (1:32 ET) Minutes submitted by Jennifer Alpert Palchak ................
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