eTMF metadata vocabulary comments

1) C115476 – Preferred Term “Investigator Confidentiality Agreement” should be just Confidently Agreement since there are many people/entities at a site who must sign CDAs such as the investigator, sub-I, Institution legal representative, pharmacist. Add “CDA” to the synonyms.

2) C115529 & C115524 – are both preferred terms needed? Can Site Personnel Supporting information cover the PI license?

3) C115524 add “professional license” and “certification” to the synonyms

4) C115538 Preferred term is currently Subject Screen Log. Consider changing to Subject Screening log per ICH

5) C115577 Monitoring Visit Report, add Routine Monitoring Visit Report and Interim Monitoring Visit Report to the synonyms

6) Column I, row 116 Source Data Verification. This is information is included in the monitoring visit report. Consider deleting.

7) Row 124, Preferred Term “Study Team Curriculum Vitae”; add Study Team CV to synonyms, PI CV, Sub-I CV. If using this term then delete C115487 (PI CV) and C115488 (Sub-I CV)

8) C115697; C115463;C115588; C115560;C115700;C115701AND C115693 are 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.

9) 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.

10) C115736 Other Approvals. Consider changing the metadata term to Approvals no-IRB-IEC Committees. Synonyms: Radiology Board Approval, Research Review Committee Approval; Budget Committee Approval.

11) C115715 Medical Imagining – documents regarding standardized processes and procedures could be captured in Centralized Testing or Vendors.

12) C115496 – Study Subjects Digital Photos -This is considered source documentation and is not included in the TMF. Individual subject data is not included in the sponsor TMF.

13) C115516 – Study Subjects Digital Photos Report – This is considered source documentation and is not included in the TMF. Individual subject data is not included in the sponsor TMF.

14) C115514 – Study Subject Radiology Report – This is considered source documentation and is not included in the TMF. Individual subject data is not included in the sponsor TMF.

15) C115512 – Study Subject MRI Report. This is considered source documentation and is not included in the TMF. Individual subject data is not included in the sponsor TMF.

16) C115510 – Study Subject CT report. This is considered source documentation and is not included in the TMF. Individual subject data is not included in the sponsor TMF.

17) C115513 Study Subject Nuclear Medicine - This is considered source documentation and is not included in the TMF. Individual subject data is not included in the sponsor TMF.

18) C115515 Study subject Ultrasound - This is considered source documentation and is not included in the TMF. Individual subject data is not included in the sponsor TMF.

19) C115511- Study Subject Medical Imaging Unspecified. This is considered source documentation and is not included in the TMF. Individual subject data is not included in the sponsor TMF.

20) The following categories and sub categories are not needed since the purpose of these terms is to classify subject documents which are not part of the TMF. C115715; C115500; C115721; C115501; C115499; C115502; C115503; C115545

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