1)
C115780 Add Project Plan as synonym
2)
C115777 Vendor Oversight Plan is listed as a synonym. This is different from a Quality Plan. Quality Plan should be added as its own term.
3)
C115779 Work Instructions are often controlled documents which live under SOPs and should be listed as a synonym for SOPs
4)
C115764 Work instructions are often controlled documents which live under SOPs and should not be syonym for Operational Study Manual
5)
General Comment – The word Trial is used across many terms. Not all projects within the pharma/device space are trials. Some projects are studies.
6)
C115658 Trial Management Tracking Documents – these are not required documents and are not necessary to include in the TMF
7)
C115606 Trail Team Training Material – the definition includes both the training materials and the documentation that the training was completed. However, at the site level, there are 2 categories, 1 for the materials C115604 and 1
for the documentation that the training was completed C115674. For consistency, should there be 2 terms at the trail level as done at the site level. Or at a minimum add “training completion document” as a synonym.
8)
C115519 – The common term for this artifact is the Subject Participation Card not Form.
9)
C115462 – “Template” is not needed in the Preferred Term Template Advertisement for subject recruitment.
10)
C115518 – Consider expanding the term “other subject forms” to “other subject materials” to allow for other media than paper.
11)
C115658 – Internal process tracking is not required to be contained in the TMF. Consider deleting.
12)
C79189 – The Preferred Term should be “Regulatory Approval” or C70885 should be “Submission”. These two should be consistent.
13)
C115723 – Since most of the artifacts in this category are country specific, there should be a country Category Code.
14)
C70885 – Category code should be country and not trial
15)
C79189 - Category code should be country and not trial
16)
C115717 - Category code should be country and not trial
17)
C115734- Category code could be country and trial
18)
C115466 - Category code should be country and not trial
19)
C115530 - Category code should be country and not trial
20)
C115579- Category code should include a country code
21)
C115551- Category code should include a country code
22)
C97107 - Category code should include a country code; Synonyms: add Periodic report, Interim Report, Annual Report
23)
C115662 - Category code should be country and not trial
24)
C115724 – Category code should include a country code
25)
C115611- Category code should be country and not trial
26)
C115666 – Regulatory Tracking document is an internal process document and not required to be maintained in the TMF
Sharon
SHARON AMES | Enterprise Program Director
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NextDocs
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Phone:
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| Email:sames@nextdocs.com
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