One last suggestion related to my feedback provided yesterday:
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
Suggestion:
I definitely agree with all comments made that it is imperative to harmonize the OASIS classification
numbering system with that of the TMF Reference Model. In such cases as listed above, the different documents would be
identified in metadata for that Content Type. Please consider whether it might be useful and practical for harmonization to add a classification "Content Sub-Type" for such cases as above, e.g.
For
C115697:
C115636 Category "Clinical Trial Documents" / C115675 Subcategory "Subject Document Forms" / C16735 Content Type "Informed Consent Form" / New: Content Sub-Type: "IRB-IEC Approved" (as opposed to "Final Submitted")
Re: Images and reports: Images are usually source data kept only in the Investigator's On-Site Trial File, but anonymous copies
are sometimes filed in the sponsor's TMF, depending on the trial design and
events.
Using a Content Sub-Type classification could be useful here as well, e.g. C115642-Category "Centralized Testing" (Suggest renaming, e.g. to "Bioanalytical Testing and Examinations")/ Subcategory C115645-Subcategory Facility Documentation" / Content Type C115573 "Bioanalytical Reports" (suggest renaming, e.g. to "Results and Reports") / New: Content Subtypes:
Report-Laboratory Results, Report-Histology,
Report-Hospital, Image-Digital Photos, Report-Digital Photos, Image-Radiography, Report-Radiography,
etc.
My apologies for being late with this idea. Hope you can still use it.
Sincerely,
Anita
Pidun
Senior Clinical records Coordinator, Bayer Pharma AG