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Subject: Public review comments for etmf-v1.0-Metadata Vocabulary: Category 101 Central Trial Documents


C115636              Column C (preferred term): Whilst I understand the desire to maintain some alignment with the TMF RM, the term used is inconsistent with other category terms. The remaining categories have name reflecting a trial activity, function or process; “Central Trial Documents” is inconsistent in this respect. Although I am not able to propose an alternative, I recommend that thought is given to proposing a term that reflects a trial activity, function or process that is covered by these documents.

 

C115526              Column F (definition): There has been some discussion within industry whether a Summary of Medicinal Product Characteristics (SMPC) document or equivalent (e.g. product leaflet) is equivalent to an Investigator Brochure for some studies / products under test. Consideration should therefore be given whether the definition needs modifying to accommodate such documents or whether additional content types need to be included within this subcategory.

 

C25320                Column D (synonym): Please also include ‘Clinical Investigation Plan’. This term is commonly used for the protocol in device clinical trials and is the term used within the devices ISO standard.

 

                            Column F (definition): The inclusion of the word “formal” is not understood and is inconsistent with other definitions included within this vocabulary.  

 

                            Column F (definition): The definition should state that protocol amendments are also considered to be content type C25320; these are sometime (incorrectly) considered to be a separate content type.

 

C115627              Column C (preferred term): Protocol amendments are already included in content type C25320 (including ‘Protocol amendment’ as a synonym). To remove the confusion that already exists with the terms used in the TMF RM, I propose removal of the term ‘Protocol amendment’ in any column for this content type. The preferred term should be ‘Protocol changes’ or ‘Summary of changes’. It is a document that highlights or lists the changes in one version of the protocol (a protocol amendment) compared to the previous version (the original protocol or a prior protocol amendment).

 

                            Column E (abbreviation): As explained, avoid use of the term ‘Amendment’ or ‘Amend’.

 

C115651              Column F (definition): The definition appears to be adapted from the TMF RM. Please state [Adapted from TMF-RM].

 

C40988                Column F (definition): The term ‘optical’ is not understood. The medium upon which the CRF is recorded is irrelevant with respect to classification. It is helpful to include printed and digital in the definition but inclusion of ‘optical’ does not seem to serve any purpose.

 

                            Column G (category code): The sample CRF should be classified with other Subject Document Forms i.e. subcategory 101.11

 

C115675              Column C (preferred term): The content types included within this subcategory are not necessarily forms, particularly for EDC studies and for advertising materials. I suggest removing the word ‘Forms’.

 

C115589              Column C (preferred term): Subject diaries are not necessarily forms. I suggest removing the word ‘Form’.

 

C115559              Column C (preferred term): Subject questionnaires are not necessarily forms. I suggest removing the word ‘Form’.

 

C16735                Column D (synonym): ICF is a commonly used synonym for Informed Consent Forms.

 

C115517              Column C (preferred term): Subject information sheets are not necessarily forms. I suggest removing the word ‘Form’.

 

                            Column C (preferred term): This content type is more commonly known by the term ‘Subject Information Sheet’. I suggest using this as the preferred term.

 

C115519              Column C (preferred term): This content type is not usually a form. I suggest using ‘Subject Participation Card’ as the preferred term.

 

C115462              Column C (preferred term): The word ‘template’ has not been used for other content types that are templates. The definition makes is clear that this content type is the template or sample advertising material so ‘template’ can be removed from the referred term.

 

C115518              Column C (preferred term): Documents which fall into this category are not often forms. Please avoid using the word ‘form’ to avoid user confusion.

 

C115575              Column C (preferred term): Inclusion of the word ‘Final’ gives the impression that interim reports are not required. In addition, there an eTMF has document authoring and lifecycle management functionality, draft documents will be classified against this content type. The word ‘final’ is not necessary.

 

C115637              Column C (preferred term): The inclusion of the word ‘documents’ in unnecessary and not included elsewhere for category and subcategory terms. Propose changing to ‘Central Trial Communications and Tracking’.

 

C115596              Agree with proposals.

 

C115638              Agree with proposals.

 

C115597              Agree with proposals.

 

C115546              Agree with proposals.

 

 

Eldin Rammell

Managing Director, Rammell Consulting Ltd.

 

 



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