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User Requirements (No replies)

David Gwyn
4 years ago
David Gwyn 4 years ago

During our last meeting the question was raised regarding the purpose of our efforts - what user requirements did we have that we were trying to address? This question spawned terrific dialog which lead us to the realization that we have not yet documented the true user requirements. The list below was provided Eldin from feedback received from the model. Hopefully we can cull through this list and use it to identify user requirements for the presentation group. Please feel free to put requirements you see in this list or others you  define in response to this thread.

001 Pertaining to Artifact Numbers: we add a "Level" on top of the Zone for numbers. For example, all Trial Level docs begin with 1, Country level = 2 and Site Level = 3. Therefore, our artifact numbers will be, for example, 101.01.01 for a Trial level doc or 301.01.01 for a site level doc.
003 I would like to see the "wet ink" column removed from the model. Wet ink has no legal significance and is at minimum an anachronism in an electronic age and at worst invites duplicating records unnecessarily.
004 My company uses the RM to map study records. We have added columns useful for tracking purposes, e.g., record owners, record location (site repository, sponsor, data management or study team and so on), and retention requirements. The problem we are currently struggling with is trying to limit the use of free text while remaining flexible
005 we have also locked the zone and artifact name cells in our model so that individual teams can't change them. We also prohibit adding new artifacts. If a team truly can't find a spot on the model for a particular record, they are to make an informed decision as to filing and record the decision in their TMF plan. Based on prior experience we have become very anti-cowboy with our records management.
006 Submitted 'delete artifact' requests for Filenote, in all zones. Any notes pertinent to an artifact should be filed with the artifact. This folder runs the risk of becoming a risky catch all for things that may not really belong in the TMF
008 We found that the sections of BioStat, Regulatory and Safety were very difficult when mapping.
009 Definitions/purposes to be updated with clearer guidance text to allow easier identification of company documents when mapping to RM. More examples would be good.
010 Include more examples of documents for each artifact
011 Guidance text to inform that for some artifacts only one document is required and for others multiple documents.
012 Sharing examples from companies mapping would be extreamly helpful.
013 Processes are often beginning in one area and taken over by another area which finalise the documentation that is used. It was very difficult to determine how to map the documentation linked to the process ended up in Regulatory, but initiated in Safety and which of these documents/data to include in the TMF. Better guidance for this in the RM is a big wish.
014 Guidance text to help mapping documents. General guidance to how to handle documents where translations are available. How to handle the documents as specific to the translation (contract, back translations, translation verifications etc) that is very specific to the specific document. Examples in possile solutions to how to map and how to file those.
015 In TMF RM v1 there was a unique ID number. I had thought this was a really good idea but I note that it's disappeared.
016 Add suggested/recommended metadata for each artifact
017 Design and use a more graphical interpretation of the RM to improve comprehension. Easier to consume. Offer in addition to Excel sheet.
018 "Committee" artifacts are incomplete and inconsistent in granularity. Independent data monitoring committee has three distinct types of documents. Adjudication and Device committees just have "ducment" and there is then another bucket for other committees. Our clients' committees have included Data Review, Device Review, Dose Escalation, Endpoint, Independent Data Monitoring, Protocol Steering Committee, Recruitment and Retention, and there are no doubt more than that. Suggest a more general approach that would apply a committee type via metadata and not force the user to either make use of a confusing general bucket or constantly add new artifact types.
020 For the zone names, section names, and artifact names: Consider using dashes (-), instead of slashes (/). Slashes are illegal characters and may cause trouble if copied directly as folder names or in systems.
021 For Columns L thru O: we found the use of X and NO to be a little confusing. Can "X" be changed to "Yes"? (see example in Leah's completed feedback sheet)
022 How are notes to file tagged in the TMF? Are they (a) stored “in place of” a document or (b) stored under the general “File Note” artifact?
023 For all artifacts in the 'General' section of each zone, recommend to change the Artifact Name to include the name of the zone, so that the definition is note dependent on inclusion of the artifact #. Example: Under Zone 01, change artifact 'Tracking Information' to be 'Trial Management Tracking'
024 Fix the gap in Artifact numbers in Section 02.01 or if this for ISF Source Documents, include them but 'grey' them out and include a statement in Definition/Purpose
025 Need to define where a CRO fits in the Model; Third Party or not?
026 Columns M, N, O and P need clearer, more user friendly abrreviations
031 If company chooses to customize index and adds an artifact number, what is your suggestion so that we avoid choosing an artifact number that may be assigned in a later version of the DIA Reference Model?
032 How do you document an artifact that will be housed outside of the TMF (or do you not permit documents to be outside of the TMF)? For example, TLF, safety reports, regulatory submission documents.
033 Include a cheat sheet tab to further describe the intent of column headings, e.g., process number and process name, and include tips on how to manage each level (trial level, country level and site level). With the current layout of the model, columns T, U and V indicate whether a document applies to a trial level, a country level or a site level (or perhaps all three). We found this layout difficult because if a document might be found at both a trial level AND site level, the definition cannot be tailored to one or the other. We found that laying out the model in such a way that all Trial level documents are gouped together, all country level docs are grouped together and all site level docs are grouped together helped us to better grasp which documents will be filed where, and allowed us to futher tailor a definition to its specific purpose. So if the artifact for ICF might apply to all three levels, you'd find it in the index 3 times (once in each of the document level sections). This also helps if you plan to use your index as a sort of checklist for items that are still outstanding from your TMF. If there is only one line in the spreadsheet for a model and a site-specific ICF, it makes it difficult to just check a box for which documents have already been submitted to the TMF.
034 Suggest developing an interactive model to include a pre-build checklist for complex international trials, single site trials, etc., to ensure outline is all inclusion to cover all scenarios and eliminate the need for customization.
036 Overall, complete a spell check there are various spelling errors throughout the model
043 Some artifact names include the word 'document' whilst others do not. There should be consistency. For example, 'Adjudication Committee Document' and 'Dose Escalation'.
044 Ensure section labels are unique (e.g. currently multiple instances of 'General'
045 Ensure artifact names are specific to the sections they correspond to. For example, 'Filenote - Statistics General' rather than 'Filenote'.
046 Remove any characters that are typically illegal in Windows filenames e.g. &
047 Ensure artifacts names, zone labels and sections labels are less than 256 characters long
048 Ensure purpose/description field does not include the word that is being defined i.e. the artifact name.
049 Include individual rows for each zone label and each section label (as in the feedback spreadsheet) with a definition for each zone and each section.
052 Review use of unique artifact identifier and make more prominent. Promote use of this field as the primary key for an artifact e.g. make it the first column in the spreadsheet.
053 Change 'Artifact Name' to 'Artifact' and include an additional column called 'Document'. The new 'Document' field might be pre-populated with EXAMPLES but should be amended by the company to capture specific documents that are filed to the specified artifact.
054 For zone, section and artifact columns, add another column called "Zone Label", "Section Label" and "Artifact Label" for the company to specific what label they will use to describe that field within their system. The default is to use the Ref Model terminology but inclusion of these 3 additional fields facilitates customization without moving away from the model itself.
055 Federal funded research from government grants, contracts or cooperative agreements have additional requirements set forth from Department of Health and Human Services/ Public Health Act and 45CFRPart46 Common Rule. Consider adding as new artifacts or expanding description in sections regarding Financial Disclosure and IRB/EC. For Example, Artifact-IRB Registration Number/OHRP Registration Number- To document registration for reviewing federal funded research and compliance with OHRP Protection of Human Subjects for research sites.
056 Speciality Laboratories such as Microbiology Labs does not have a section.
062 Provide guidance for creating artifact numbers when adding new artifacts. The numbering should align with the applicable zone and section however, be readily identifiable as a company added artifact. Use of the next consecutive number should be avoided in the event the RM uses the number in a future release. For example adding new artifacs in zone/section 01.01 could be identified as. 01.01.99901, 01.01.99902
063 Provide an approach for managing QC documentation per EU Directive 2005/28/EC Articles 2[4]. 16 and 17. " Examples include evidence of QC checks, documentation on Regulatory Green Light, database lock forms" While the RM does account for IP Green light documentation and database lock forms there are documents and packages of documents which require QC checks per company SOPS, e.g. Informed Consent Review checklists. Approach could be classifying as the document the QC is being performed on, or add another artifact in each zone called "QC documentation" similar to file note and correspondence.
064 There is guidance for when an artifact could be expected at the Trial, Country, and/or Site. However additional guidance regarding how to implement these classifications is needed. There are artifacts where it is almost mandatory to have one artifact in the 3 domains, e.g. the ICF, the Trial template, the Country version of the Trial template, and the final IRB approved Site Version. However for other artifacts such as the Trial Team Training or Protocol Amendment, it might be the company's preference to maintain all of these at the Trial and not create subcategories for each country. How this is handled is based on multiple factors, e.g. paper vs electronic TMF; if eTMF, the software capabilities, and the company's preferences or business processes.
065 Provide guidance regarding how to classify document translations. Should each artifact included all applicable translation documents or should there be an artifact per zone for translations similar to meetings and file notes?
069 Should TMF RM description about that the TMF does not list out approval forms and translations also doesn't include document checklists
070 I am in favor of a new zone for system validation documentation. With the amount of systems used to collect, create, maintain, archive TMF content, the 2 indications in the TMF RM for study-specific system validations is insufficient.
072 People hate how the ordering of the TMF RM are disjointed. Could be because new artifacts are added in later versions. I get the reason as the plans fall into different sections but users find this difficult to follow…like all plans are not stored together.
073 Address NTFs specific to an artifact versus a general NTF for the section or process.
074 Can we obtain the feedback that was provided to OASIS when their proposed model was reviewed? There could be items relevant for TMF RM revisions as well
075 Some artifacts that present groups of documents (e.g. Meeting material, Communication, Tracking Information, CVs...) - Consider structuring as sub-classification that allows further specification of context of use and type of document; a list of standard terminology, rather than listing as individual document types. Would like to see opinions on grouping those together in a new zone/section of eg.: administrative/general - See examples to the right
077 For consistency use singular form for artifacts; avoid abbreviations
078 To manage translations: relationship and language attributes needed for all artifacts