Feedback comments for draft specification version 1.0 and Vocabulary List

[Anita Pidun <anita.pidun@yahoo.com>]

Dear OASIS Team,

Congratulations on all of the hard work so far!

Here are the comments that I had time for:

Re: eTMF Specification Version 1.0 – Draft, 18.April.2014:

• Page 6, section 1.3 – Non-Normative References: 
  The TMF Reference Model version 2.0 (URL: at DIA EDM Corner) should be added to this reference list since it is also used as a mapping cross-reference in the OASIS eTMF vocabulary list, as stated on page 10.
  Highly recommend that all document artifacts listed in the TMF RM are assigned a classification in the OASIS eTMF, otherwise documents might be omitted that should be filed in the eTMF, to prevent them from having to be entered later as organization-specific (Sub-) Categories or Content Types.
• Page 11, section 5.1 – Classification Categorization:
  The Primary Categories in the eTMF domain are numbered from 100 – 199, providing 100 primary category divisions. Seems to be too much granularity – too many primary categories could make it less intuitive / harder to maintain eTMF oversight. In the eTMF Vocabulary List, only 100 – 111 have been used. If 112 – 199 are not needed, suggest to assign primary categories in a more intuitive way which would parallel the eTMFs already in use in the industry based on the TMFRM, e.g. 100, 200,…110 (analogous to TMF RM zones 1 – 11).
• Page 12, section 5.1.1.2 - Classification Categories Naming Scheme:
  The description of the sub-categories concept is a bit confusing, and is not reflected in the Vocabulary List. As I understand it, the description implies there can be both primary and secondary subcategories, and up to 5 additional (sub-) sub-categories can be assigned within a sub-category, which might become a potential source of classification error, if this results in sub-categories that have the same numbering code as the Content Types (with the exception of "T" in front of the sub-category number), e.g. as in the example "142.23.67".
  Suggest that either the definitions on page 12 need to be rephrased, or that a simpler structure be considered for the OASIS eTMF, e.g. "Category / Sub-category / Content Type" analogous to the TMFRM "Zone / Section / Artifact" structure to avoid complicated search and retrieval of documents (Latter option is what it appears to be so far in the vocabulary list).
• Page 13, Section 5.1.1.3 – Figure 9, Example:
  In Figure 9, the example "Trial Team CV" is classified as both a Subcategory (100.11.10) and a Content Type (T100.11.10.11), which seems redundant. However, in the Vocabulary List "Trial Team CV" is classified appropriately only as a Content Type (not as a subcategory) with number T100.11.11. Please review / revise the example in Figure 9.

RE: Oasis-eTMF-Standard - DRAFT metadata vocabulary spreadsheet:

• C115529 / PI License = TMFRM 090 / Site and Staff Qualification Supporting Information
• C115537 / Subject Enrollment Log = TMFRM 105 / Subject Log
• C115685 / Data Validation Certification = Prefer TMFRM 246 / Validation Documents
  Note: "244 / Database Change Control (Paper and EDC)" is not applicable here, refers to documents for CRF changes requested during a study (application modification requests, etc.)
• X______  NEW: To be submitted. (Curriculum Vitae C54631…..)/ Study Team Curriculum Vitae, T104.11.39 = TMFRM nos. 087 (Principal Investigators), 088 (Sub-investigators) and 089 (Other site staff), i.e. all 3 artifacts.
• I see no Subcategory for Ongoing / interim Monitoring and study Close-out Monitoring in Category 104-Site Management. Several of the study conduct Monitoring Report Content Types (C115577, C115536, C115737, C115664, C115648, C115581, C115673, C115537, C115538, C115581) are incorrectly classified under Site Set-up Documentation (Category 104.11), and should have their own subcategory following Subcategory 104.12 (Site Initiation/ Training) 241 Monitoring Visit Follow-up Letter (under review) would fit in Category 104 with these documents as well.

• I feel very strongly that IEC / IRBs should have their own category, not be a subcategory of Category 104, for the sake of flexibility. Many countries do still have local site-specific IEC/IRBs, but there are also many have only a national IRB/IEC which is not site-associated, or a leading IEC/IRB which provides the approval for all sites in the country. Many of the submitted and "IRB-IEC Approved" documents are only applicable at study or country level – not separately for each site. Many IECs/IRBs can be responsible for more than one site within a country without being responsible for all. I know of at least 2 countries where the submission documents for IEC/IRB review are required to be submitted to the national health authority which reviews and routes these to the national or local IEC/IRBs as required. EMA has also thought about forming an EU-Regional IRB – one more reason not to classify IEC/IRB documents as site-specific.

• C115716 and C115736 (Other submissions and approvals / under review) – yes, these are needed according to local laws, as stand-alone documents and sometimes for submission to IEC/IRBs.

Note – In the TMFRM Model, all versions (draft + approved, translated, Study/ Country/ Site levels) are included in the designated artifact ("IRB IEC Approved" is considered to be metadata):

• C115697 IRB-IEC Approved Informed Consent (= TMFRM 040 / Informed Consent Form)
• C115463 IRB-IEC Approved Advertisement for Subject Recruitment (043 / Advertisements for Subject Recruitment)
  C115462 / Template Advertisement for Subject Recruitment is also included in 043 – would be the version submitted to the IEC-IRB for review prior to approval.
• C115588 IRB-IEC Approved Subject Diary (038 / Subject Diary)
• C115560 IRB-IEC Approved Subject Questionnaire (039 / Subject Questionnaire)
• C115700 IRB-IEC Approved Subject Information (041 / Subject Information Sheet)
• C115701 IRB-IEC Approved Subject Participation (042 / Subject Participation Card)
• C115693 IRB-IEC Approved Other Subject Information (044 / Other written information given to subjects)

All of the below = TMFRM 162 / Laboratory Results Documentation (see definition – includes "or other testing facility"):

• C115496 Study Subject Digital Photos
• C115516 Study Subject Digital Photos Report
• C115561 Study Subject Radiography Image
• C115514 Study Subject Radiography Report( findings associated with an X-ray image)
• C115539 Study Subject MRI Image
• C115512 Study Subject MRI Report
• C115481 Study Subject CT Image
• C115510 Study Subject CT Report
• C115553 Study Subject Nuclear Medicine Image
• C115513 Study Subject Nuclear Medicine Report
• C115619 Study Subject Ultrasound Image
• C115515 Study Subject Ultrasound Report
• C115523 Study Subject Medical Imaging Unspecified
• C115511 Study Subject Medical Imaging Report Unspecified

TMFRM Terms currently not part of OASIS eTMF – in Review:

These TMF documents are filed only at the Investigator Site (ISF only)- not needed unless you are also planning for e-ISFs / (should not be filed in the sponsor's TMF files):

• 234 Subject Identification Log
• 235 Source Data

If possible, recommend to add these to the eTMF list since they are sometimes provided / required to be in the sponsor's TMF:

• 236 Risk Management Plan --> Subcategory 100.10
• 237 Vendor Management Plan --> Subcategory 100.10
• 238 Device Review Committee --> Subcategory 100.12
• 239 Report of Prior Investigations --> Subcategory 101.10 (device trial document analogous to the IB for clinical trials)
• 240 Investigators Agreement (Device)-->Subcategory 104.11 (= Investigator's Contract)
• 245 Technical Design Document --> Subcategory 109.12

Thanks very much for the opportunity to review.

Regards,

Anita Pidun

Senior Clinical Records Coordinator, Bayer Pharma AG

Member: TMF Reference Model Group