NCIt Code | Preferred Term | TMF RM Term (TMF-RM V2.0_25June12) | Comments |
C115781 | Site Management Communications and Tracking | | 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 | Site Management Tracking Document | Tracking Information | Do not use "Documents" in the preferred term…Use TMF RM term. |
C115549 | Site Management Filenote | Filenote | Important to remain in the TMF |
C115568 | IP Transfer Record | IP Documentation of Transfer | I would suggest that this term be broadened to all the documentation associated with relabeling…and applicable at trial, country, and site level. Call it IP Transfer Documentation. |
C115759 | IP Re-labeling Plan | Re-labeling Documentation | I would suggest that this term be broadened to all the documentation associated with relabeling…and applicable at trial, country, and site level. Call it IP Relabeling Documentation. |
C115758 | IP Recall Plan | IP Recall Documentation | I would suggest that this term be broadened to all the documentation associated with recall…and applicable at trial, country, and site level. Call it IP Recall Documentation. |
C115566 | IP Return Record | IP Documentation Return | Prefer TMF RM term "IP Documentation of Return" |
C82524 | Subject Unblinding Plan | Unblinding Plan | Prefer TMF RM term as the Unblinding plan is not only at the subject level, it can be at the trial level |
C115572 | Subject Unblinding Event | Treatment Decoding Documentation | Preferred term is not one that the industry will identify with. Prefer the TMF RM term |
C115677 | Trial Supply Storage | | Remove "Trial Supply" and This subcategory name is not correct…it should be IP Storage] |
C115676 | Trial Supply Storage Conditions | Storage Condition Documentation | Remove "Trial Supply" and Shouldn't this have "documentation" or record after it….like was done for other preferred terms. Prefer TMF RM term |
C115678 | Trial Supply Storage Condition Excursions | Storage Condition Excursion Documentation | Remove "Trial Supply" and Shouldn't this have "documentation" or record after it….like was done for other preferred terms. Prefer TMF RM term |
C115706 | IP Documents Communications and Tracking | | 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 | IP and Trial Supplies Tracking Document | Tracking Information | Do not use "Documents" in the preferred term…Use TMF RM term. |
C115506 | IP and Trial Supplies Filenote | Filenote | Important to retain in the TMF. |
C115727 | Safety Reporting Communications and Tracking | | 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 | Safety Tracking Document | Tracking Information | Do not use "Documents" in the preferred term…Use TMF RM term. |
C115507 | Safety Filenote | Filenote | Important to retain in the TMF. |
C115642 | Centralized Testing | | Not all preferred terms will be relevant to all types of centralized testing facilities. Just and FYI when you consider names of the preferred terms. Not all centralized testing will be "Labs". Need this to be more general. |
C115712 | Laboratory Certification | Certification or Accreditation | Remove "Lab" from preferred term |
C115542 | Bioanalytical Validation Methods | Laboratory Validation Documentation | Do not agree with addition of Bioanalytical |
C115573 | Bioanalytical Reports | Laboratory Results Documentation | Do not agree with addition of Bioanalytical to the term. Prefer the TMF RM term. This is NOT only bioanalytical related. Since centralized testing could be done at a non-laboratory. Important to hold all other subject data that does not have a place specifically identified. However, one does not have to specific unique preferred terms and instead retain this preferred term as the general one and let metadata distinguish the different types. This is a preferred method since a subject could have multiple types of source data and it would be all together organized and listed with the same preferred term - and metadata should uniqueness of the multiple entries. |
C115541 | Lab Manual | Manual | Remove "Lab" from preferred term |
C115738 | Lab Supply Import Documentation | Supply Import Documentation | Remove "Lab" from preferred term |
C115490 | Laboratory Director Curriculum Vitae | Head of Facility Curriculum Vitae | Remove "Lab" from preferred term. Use TMF RM term |
C115655 | Laboratory Sample Details | | Remove "Lab" from preferred term |
C115569 | Laboratory Shipment Records | Shipment Records | Remove "Lab" from preferred term |
C115640 | Centralized Testing Communications and Tracking | | 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 | Centralized Testing Tracking Document | Tracking Information | Do not use "Documents" in the preferred term…Use TMF RM term. |
C115504 | Centralized Testing Filenote | Filenote | Important to retain in the TMF. |
C115743 | Vendors | | I prefer "Third Parties". So many sponsors do not see CROs as Vendors. Remove "Vendor" from all preferred terms |
C115744 | Vendor Oversight | | Add synonym "Vendor Oversight Plan" which was removed from C115777 |
C115690 | Evidence of Contractor Compliance | Qualification and Compliance | A better name for this would be "Evidence of Oversight" since the section is not specific to contractors but all vendors. Also, yes, this would include evidence, but it also includes the plan for oversight. Prefer the TMF RM term. |
C115745 | Vendor Records | | This category name means nothing to me. Too general. Use TMF RM Section name. |
C115742 | Vendors Communications and Tracking | | 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 | Vendor Tracking Document | Tracking Information | Do not use "Documents" in the preferred term…Use TMF RM term. |
C115509 | Vendor Filenote | Filenote | Important to retain in the TMF. |
C115749 | Annotated Case Report Form | Annotated CRF (Paper and EDC) | Why not abbreviate CRF here as was in C115750? Inconsistencies! |
C115520 | Completed Case Report Forms | Completed CRFs (Paper) | Why not abbreviate CRF here as was in C115750? Inconsistencies! |
C115521 | Data Clarification Forms | Documentation of Corrections to Entered Data (Paper) | I prefer the TMF term as it is more general to the industry and from the ICH |
C115725 | Serious Adverse Event Data Reconciliation | SAE Reconciliation (Paper and EDC) | Why not abbreviate SAE here as was in 115587? Inconsistencies! |
C115757 | Database Quality Plan | Data | This will include more than the plan; it will include results as well. Use the TMF RM term |
C115685 | Data Validation Certification | Database Change Control (Paper and EDC) | To me, the preferred term and the TMF RM term are 2 different things. This preferred term should be more than just a certificate. |
C115687 | Database Account Management | System Account Management | Preferred term is incorrect. The system access is managed, not the database. Use the TMF RM term. |
C115681 | Data Management Communications and Tracking | | 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 | Data Management Tracking Document | Tracking Information | Do not use "Documents" in the preferred term…Use TMF RM term. |
C115505 | Data Management Filenote | Filenote | Important to retain in the TMF. |
C115621 | Randomization Validation | Randomization Sign Off | Preferred term is incorrect. Randomization is not validated in all cases. Use the TMF RM term. |
C115495 | Interim Analysis Raw Datasets | Interim Analysis Raw Datasets | Important to retain in the TMF. Could be applicable to an interim analysis as well as an IDMC analysis, etc. |
C115484 | Interim Analysis Programs | Interim Analysis Programs | Important to retain in the TMF. Could be applicable to an interim analysis as well as an IDMC analysis, etc. |
C115493 | Interim Analysis Datasets | Interim Analysis Datasets | Important to retain in the TMF. Could be applicable to an interim analysis as well as an IDMC analysis, etc. |
C115555 | Interim Analysis Output | Interim Analysis Output | Important to retain in the TMF. Could be applicable to an interim analysis as well as an IDMC analysis, etc. |
C115585 | Interim Statistical Reports | Interim Statistical Report(s) | Important to retain in the TMF. Although could be moved to Central Trial Documents |
C115582 | Statistical Report | Statistical Report | Important to retain in the TMF. Although could be moved to Central Trial Documents |
C115729 | Statistics Communication and Tracking | | 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 | Statistics Tracking Document | Tracking Information | Do not use "Documents" in the preferred term…Use TMF RM term. |
C115614 | Statistics Meeting Material | Meeting Material | Important to retain in the TMF. |
C115508 | Statistics Filenote | Filenote | Important to retain in the TMF. |
C115715 | Medical Imaging | | Cannot understand why these specific types of source data are separated out. Identifying some but not all will be confusing to the general TMF owner and will create a lot of extraneous content types to sift through to manage e content. Why could these not be a single type with metadata to distinguish. This is a really big change to the TMF structure list that was kept broad for a reason...to allow wide spread use and acceptance across the world's bio pharma and device companies. Not aligned with the TMF RM. |
C115500 | Digital Photographs | | See 115715 |
C115496 | Study Subject Digital Photos | | See 115715 |
C115516 | Study Subject Digital Photos Report | | See 115715 |
C115721 | Radiography | | See 115715 |
C115561 | Study Subject Radiography | | See 115715 |
C115514 | Study Subject Radiography Report | | See 115715 |
C115501 | Magnetic Resonance Imaging | | See 115715 |
C115539 | Study Subject MRI | | See 115715 |
C115512 | Study Subject MRI Report | | See 115715 |
C115499 | Computed Tomography | | See 115715 |
C115481 | Study Subject CT | | See 115715 |
C115510 | Study Subject CT Report | | See 115715 |
C115502 | Nuclear Medicine | | See 115715 |
C115553 | Study Subject Nuclear Medicine | | See 115715 |
C115513 | Study Subject Nuclear Medicine Report | | See 115715 |
C115503 | Ultrasound | | See 115715 |
C115619 | Study Subject Ultrasound | | See 115715 |
C115515 | Study Subject Ultrasound Report | | See 115715 |
C115545 | Medical Imaging Unspecified | | See 115715 |
C115523 | Study Subject Medical Imaging Unspecified | | See 115715 |
C115511 | Study Subject Medical Imaging Report Unspecified | | See 115715 |
C115785 | Electronic Trial Master File | | Please use derivative of the MHRA's definition of a eTMF per the MHRA GCP Guide. |
C115784 | Trial Master File | | Please use ICH definition of the TMF, not Carelex's interpretation. |
C114548 | CareLex eTMF Terminology | | It is not understood why this term is included within the vocabulary. It adds nothing other than to provide an opportunity to promote CareLex. |
C114463 | Archive | | The definition provided will lead to confusion. GCP regulations also use the term “archive”, “archiving” and “archivist” to have a very different meaning. An archive is a repository that is designed specifically for the long term retention and preservation of records and is NOT a general digital file store. |
C115468 | Category | | The definition provided will lead to confusion. GCP regulations also use the term “archive”, “archiving” and “archivist” to have a very different meaning. An archive is a repository that is designed specifically for the long term retention and preservation of records and is NOT a general digital file store. |
C20108 | Country | | Absolutely critical to the organization of the TMF |
C83082 | Study ID | | Absolutely critical to the organization of the TMF |
| | | |
| | Subject Identification Log | Important artifact in the TMF; not a subject screening log as indicated as a synonym to. |
| | Source Data | Important artifact in the TMF, the investigator portion of the TMF. |
| | Risk Management Plan | Important artifact in the TMF. Required by MHRA and a very comment artifact in the TMF. |
| | Vendor Management Plan | Important artifact in the TMF. Required by MHRA and a very comment artifact in the TMF. |
| | Device Review Committee | Important artifact in the TMF for Device studies. |
| | Report of Prior Investigations | Important artifact in the TMF for Device studies. |
| | Investigators Agreement (Device) | Important artifact in the TMF for Device studies. |
| | Monitoring Visit Follow-up Letter | Important artifact in the TMF. Expressly requested by TMF community to be called out uniquely from other communications with the sites. |
| | Technical Design Document | Important artifact in the TMF; important for EDC studies. |
Sincerely,
Lisa Mulcahy
412-213-3050