NCIt Code | Comments |
C115780 | Add Project Plan as a synonym |
C115777 | Vendor Oversight Plan is not the same as the Quality Plan and Is there a typo in the Synonym "Join"? Though honestly, I think the name "Join Vendor Oversight Plan" needs to remove the "Join" and it be placed as a synonym of C115744. |
C115779 | Term "SOP List" is not descriptive of that needs to be captured. Use TMF RM term which comes directly from ICH |
C115783 | Remove "s" from "Comms" in the abbreviation |
C115753 | Synonym "Monitoring Data Plan" is not a common synonym used by the industry. I would suggest to remove. |
C115557 | Remove "s" from "Pubs" in the abbreviation. Use TMF RM description as it is more accurate "To describe the policy for publishing the trial results if publication policy is not captured within the protocol or Clinical Trial Agreement." |
C115580 | Is the Abbreviation correct "Stas"? I would suggest 'Stat" |
C115556 | I think the term "Oversight" is not always correct and needs to be removed since there included in this section are Steering committees, adjudication committees, approval committees, etc. |
C115740 | Too long a term and could be confusing, please use TMF RM term "Other Trial Committee" inducing description and change Abbreviation to "Oth Trial Cmte Doc" |
C115647 | Remove "s" from Document in the preferred term name to stay consistent with other terms |
C115605 | Do not agree with this sub category name since any of the preferred terms could happen at any point during the trial. Use the TMF RM term "Meetings" |
C115656 | Name of sub category is not reflective of the content within as it is missing the meeting documentation and filenotes. Add "meeting documentation and file notes" into the description. |
C115658 | Do not use "Documents" in the preferred term…Use TMF RM term. |
C115547 | Rename to 'Trial Management Filenote" |
C115646 | "Core" doesn't mean much here and can be very confusing to the TMF RM community since we use the term "Core" for another purpose. Recommend removing term |
C115675 | Term "Form" is not commonly use when referring to these preferred terms. Remove. |
C115589 | Term "Form" is not commonly use when referring to this preferred term. Remove. Also diaries are not forms anymore…they are electronic |
C115559 | Term "Form" is not commonly use when referring to this preferred term. Remove. |
C16735 | Replace patient with subject in description. Not all participants in a clinical trial or study is a patient. |
C115517 | Term "Form" is not commonly use when referring to these preferred terms. Remove. Replace with "Sheet". |
C115519 | Term "Form" is not commonly use when referring to these preferred terms. Remove. Replace with "Card". |
C115462 | Remove "template" as it is irrelevant as all trial and country level documents are templates in this section. |
C115518 | Use Term "Form" is not commonly use when referring to these preferred terms. Remove. TMF RM term is aligned with ICH and accepted industry term. Add additional description that TMF RM has "To be provided to the subject to further assist with understanding the trial requirements or concepts; may include memory aids." |
C115575 | Remove "Final" as not all time are the reports captured in this section would be final. |
C79176 | Use the more comprehensive description from the TMF RM "To describe final or interim results and interpretation of trial of any therapeutic, prophylactic, or diagnostic agent conducted in human subjects, in which the clinical and statistical description, presentations, and analyses are fully integrated into a single report; contains data listings and summaries." |
C79278 | Change preferred term to 'Bioanalytical' Report as this is more broad and can then include multiple types of reports not just PK. Update description to be "Documentation that presents and summarizes the findings of the bioanalytical analyses from a trial." |
C115637 | Name of sub category is not reflective of the content within as it is missing the meeting documentation and file notes. Add "meeting documentation and file notes" into the description. |
C115596 | There are communications associated with the creation and distribution of central trial documents |
C115638 | Do not use "Documents" in the preferred term…Use TMF RM term. |
C115597 | There are trackers associated with the creation and distribution of central trial documents |
C115546 | There are filenotes associated with the creation and distribution of central trial documents |
C115723 | Is this content organized in a country level process. I do not see a country level file in this model. All of this content is unique per country. Sites within the country supported but the country TMF content. |
C115665 | Update description to include "regulatory submissions and approvals." |
C70885 | This term should be Approval to stay consistent with C79189 |
C79189 | This term should be Regulatory Approval to stay consistent with C70885 |
C115734 | TMF RM name is more accurate since the registrations are public. The content in this section contains internal processes for the collection and approval of the content to be placed on a public registry as well as the documentation that it was placed. |
C115702 | This is a very confusing sub category name. I had to reread it to make sure I was in the correct section "regulatory". Suggest to change to "Licenses" |
C115579 | Remove "Trial" from the preferred term name as this could be added to most term names. Doesn't add anything here. |
C97107 | Add synonyms "Periodic report, Interim Report, Annual Report" |
C115724 | Name of sub category is not reflective of the content within as it is missing the meeting documentation and filenotes. Add "meeting documentation and file notes" into the description. |
C115666 | Do not use "Documents" in the preferred term…Use TMF RM term. |
C115691 | I do not think the including of "Sponsor" in the category name is 100%. I would remove as it only limits the content to be placed. |
C115480 | I do not think the including of "Sponsor" in the category name is 100%. I would remove as it only limits the content to be placed. |
C115692 | Do not use "Documents" in the preferred term…Use TMF RM term. |
C115671 | Add synonym "Investigator Site List" |
C115476 | Remove "Investigator" since there are others at the sites that sign the CDA who are not investigator. Limiting. Change abbreviation. Add “CDA” to the synonyms. |
C115739 | Abbreviation makes no sense since this level of abbreviation was not used previously. Maybe "Sites Eval N Sel" |
C115654 | Description should be clarified to say " investigators and investigative site". |
C115711 | Most common term I see is "IB Receipt" |
C115529 | Remove! This is not a required document in the TMF. Is a subtype of the Documentation of Staff and Site Qualifications, C11524, which would be applicable to SOME of the sub-investigators. |
C115524 | Site qualifications is a unique type of content collected that ensures the site has all of the requirements to conduct the study. Use the TMF RM artifact name/term and description as it is in the TMF RM "To document site / site staff qualifications not previously outlined on CVs. May include list of previous studies, publications, training certificates for specific examinations, ICH-GCP training, site GCP or trial licensure, medical licenses etc. Description needs to be broadened to qualification documentation for not only investigators. |
C115673 | Consider revised name of preferred term "Site Signature and Delegation Log" |
C115538 | Preferred term is currently Subject Screen Log. Consider changing to Subject Screening log per ICH. |
| Source Data Verification is valuable TMF artifact as it is used and sometimes retained when remote monitoring is conducted. Applicable at all 3 levels. |
C115577 | add Routine Monitoring Visit Report and Interim Monitoring Visit Report to the synonyms |
C115664 | Abbreviation sounds weird. Maybe "Prot Deviatn" |
X______ NEW: To be submitted. (Curriculum Vitae C54631 too general for our definition) | If this will be added, "Study Team" is too general a term and could have confusion as "study team" exist at some many levels. May also allow duplication of PI and SI CVs here too. The definition even allows it! I still think TMF RM term is mostly right as well as the definition "To document qualifications and eligibility of site personnel other than the Principal Investigator or Sub-Investigators to conduct trial and/or provide medical supervision of subjects." |
C115696 | Do not agree with IRB documentation being captured separately apart from country level IRB-IRC documents. |
C115616 | all IRB-IEC approved artifacts. These artifacts are already accounted for with a Trial classification in Subject Forms. By classifying these artifacts with the Category Code of Trial they will be the template for the Trial. Adding the Category Code of country will account for the country specific template version or country central IRB approved version. Add the Category Code of Site will account for the final IRB approved version. There is not a need to additional preferred terms for these artifacts. |
C70800 | all IRB-IEC approved artifacts. These artifacts are already accounted for with a Trial classification in Subject Forms. By classifying these artifacts with the Category Code of Trial they will be the template for the Trial. Adding the Category Code of country will account for the country specific template version or country central IRB approved version. Add the Category Code of Site will account for the final IRB approved version. There is not a need to additional preferred terms for these artifacts. |
C115697 | all IRB-IEC approved artifacts. These artifacts are already accounted for with a Trial classification in Subject Forms. By classifying these artifacts with the Category Code of Trial they will be the template for the Trial. Adding the Category Code of country will account for the country specific template version or country central IRB approved version. Add the Category Code of Site will account for the final IRB approved version. There is not a need to additional preferred terms for these artifacts. |
C115463 | all IRB-IEC approved artifacts. These artifacts are already accounted for with a Trial classification in Subject Forms. By classifying these artifacts with the Category Code of Trial they will be the template for the Trial. Adding the Category Code of country will account for the country specific template version or country central IRB approved version. Add the Category Code of Site will account for the final IRB approved version. There is not a need to additional preferred terms for these artifacts. |
C115588 | all IRB-IEC approved artifacts. These artifacts are already accounted for with a Trial classification in Subject Forms. By classifying these artifacts with the Category Code of Trial they will be the template for the Trial. Adding the Category Code of country will account for the country specific template version or country central IRB approved version. Add the Category Code of Site will account for the final IRB approved version. There is not a need to additional preferred terms for these artifacts. |
C115560 | all IRB-IEC approved artifacts. These artifacts are already accounted for with a Trial classification in Subject Forms. By classifying these artifacts with the Category Code of Trial they will be the template for the Trial. Adding the Category Code of country will account for the country specific template version or country central IRB approved version. Add the Category Code of Site will account for the final IRB approved version. There is not a need to additional preferred terms for these artifacts. |
C115700 | all IRB-IEC approved artifacts. These artifacts are already accounted for with a Trial classification in Subject Forms. By classifying these artifacts with the Category Code of Trial they will be the template for the Trial. Adding the Category Code of country will account for the country specific template version or country central IRB approved version. Add the Category Code of Site will account for the final IRB approved version. There is not a need to additional preferred terms for these artifacts. |
C115701 | all IRB-IEC approved artifacts. These artifacts are already accounted for with a Trial classification in Subject Forms. By classifying these artifacts with the Category Code of Trial they will be the template for the Trial. Adding the Category Code of country will account for the country specific template version or country central IRB approved version. Add the Category Code of Site will account for the final IRB approved version. There is not a need to additional preferred terms for these artifacts. |
C115693 | all IRB-IEC approved artifacts. These artifacts are already accounted for with a Trial classification in Subject Forms. By classifying these artifacts with the Category Code of Trial they will be the template for the Trial. Adding the Category Code of country will account for the country specific template version or country central IRB approved version. Add the Category Code of Site will account for the final IRB approved version. There is not a need to additional preferred terms for these artifacts. |
C115694 | Do not agree with IRB documentation being captured separately apart from country level IRB-IRC documents. |
C115695 | Do not agree with IRB documentation being captured separately apart from country level IRB-IRC documents. |
C115594 | Do not agree with IRB documentation being captured separately apart from country level IRB-IRC documents. |
C115716 | Submissions non-IRB-IEC Committees. Synonyms: Add Radiology Board Submission, Research Review Committee Submission, Budget Committee Submission. Category code should be at the Trial, Country and site. |
C115736 | Consider changing the metadata term to Approvals no-IRB-IEC Committees. Synonyms: Radiology Board Approval, Research Review Committee Approval; Budget Committee Approval. |
C115583 | Do not agree with IRB documentation being captured separately apart from country level IRB-IRC documents. |
C115698 | Do not agree with IRB documentation being captured separately apart from country level IRB-IRC documents. |
C115584 | Do not agree with IRB documentation being captured separately apart from country level IRB-IRC documents. |
C115699 | Do not agree with IRB documentation being captured separately apart from country level IRB-IRC documents. |
C115781 | Name of sub category is not reflective of the content within as it is missing the meeting documentation and filenotes. Add "meeting documentation and file notes" into the description. |
C115670 | Do not use "Documents" in the preferred term…Use TMF RM term. |
C115706 | Name of sub category is not reflective of the content within as it is missing the meeting documentation and filenotes. Add "meeting documentation and file notes" into the description. |
C115704 | Do not use "Documents" in the preferred term…Use TMF RM term. |
C115727 | Name of sub category is not reflective of the content within as it is missing the meeting documentation and filenotes. Add "meeting documentation and file notes" into the description. |
C115728 | Do not use "Documents" in the preferred term…Use TMF RM term. |
C115640 | Name of sub category is not reflective of the content within as it is missing the meeting documentation and filenotes. Add "meeting documentation and file notes" into the description. |
C115641 | Do not use "Documents" in the preferred term…Use TMF RM term. |
C115744 | Add synonym "Vendor Oversight Plan" which was removed from C115777 |
C115690 | A better name for this would be "Evidence of Vendor Oversight" since the section is not specific to contractors but all vendors. |
C115742 | Name of sub category is not reflective of the content within as it is missing the meeting documentation and filenotes. Add "meeting documentation and file notes" into the description. |
C115748 | Do not use "Documents" in the preferred term…Use TMF RM term. |
C115681 | Name of sub category is not reflective of the content within as it is missing the meeting documentation and filenotes. Add "meeting documentation and file notes" into the description. |
C115684 | Do not use "Documents" in the preferred term…Use TMF RM term. |
C115729 | Name of sub category is not reflective of the content within as it is missing the meeting documentation and filenotes. Add "meeting documentation and file notes" into the description. |
C115730 | Do not use "Documents" in the preferred term…Use TMF RM term. |
From: Lisa Mulcahy [mailto:mulcahy67@comcast.net]
Sent: Friday, August 08, 2014 6:47 AM
To: 'etmf-comment@lists.oasis-open.org'
Cc: mulcahy67@comcast.net
Subject: Alignmnet with TMF RM
It is imperative to get alignment between the TMF Reference Model and the OASIS eTMF Model, so that for every TMF Reference Model artifact, there is a related entry in the OASIS Model. The TMF Reference model is the collaborative work of over 350 people from around 200 companies
Sincerely,
Lisa Mulcahy
412-213-3050