Public review comments for etmf-v1.0-Metadata Vocabulary: Category 100 Trial Management

["Eldin Rammell, Rammell Consulting" <eldin.rammell@rammell.com>]

C115766              Column F (definition): Change 'operations' to 'oversight'. The term 'operations' is too broad and could equate to the conduct of the trial (ie everything!).

 

C115497              Column C (preferred term); Change 'Operations' to 'Oversight'. The term 'operations' is typically understood as 'trial conduct'. This subcategory of documents corresponds with oversight of the trial.

 

C115780              Column E (abbreviation); Use abbreviation Trial Mgmt Plan; TM Plan is very ambiguous.

 

C115777              Column D (synonym): Omit 'Vendor Oversight Plan'. This is more typically a separate, distinct content type, meeting different regulatory requirements than the Quality Plan. It is covered by TMF RM artifact 237 which has not yet been included in this vocabulary.

C115779              Column D (synonym): The proposed synonyms may imply that the actual SOPs are required in the TMF. This implication should be avoided - remove synonyms.

                            Column E (abbreviation): The proposed abbreviation (SOPs) may imply that the actual SOPs are required in the TMF. This implication should be avoided - change to ‘SOP List’

                            Column F (definition): The definition may imply that only SOPs that were current for the whole duration of the trial should be itemized (ie omit ones that were superseded or became effective part through the trial). ANY SOP that was current for any length of time during trial conduct must be .listed.

 

C115764              Column F (definition): Definition could be confused with SOPs. Propose adding 'not covered by SOPs'.

 

C115753              Column D (synonym): Remove synonym 'Monitoring Data Plan'. This could be confused with 'Data Monitoring Plan' a distinct document produced by Data Management.

 

C115557              Column F (definition): the wording proposed is not easily understood. Use of the word 'approved' is unnecessary, unless it is going to be used consistently across all content types. Propose: Documentation describing the policy for publishing the trial results.

 

C115593              Column F (definition): the wording proposed is taken from a specific US regulation and therefore may not be aligned with equivalent regulations globally. Propose making the definition more generic and simple e.g. a declaration that certifies whether trial personnel are or have been barred, suspended, proposed for debarment or in some other way declared ineligible to fully participate in trial activities.

 

C115580              Column F (definition): consideration should be given to expanding the definition to avoid ambiguity with formal status reports required by regulatory agencies, IRB-IECs and other official bodies.

 

C115531              Column F (definition): change 'notes' to 'filenotes'.

 

C115556              I agree with the proposed subcategory name “Clinical Trial Oversight Committees” and definition.

 

C115532              Column F (definition): The term "directory" is not clear and could be misinterpreted. The word ‘list’ is more usually used.

 

C115740              Column C (preferred term): Omit word "Non-IDMC" as this is implied in inclusion of the word "Unspecified". Change definition to "Any document related to committees not specified elsewhere". This artifact is not restricted to just non-IDMC.

 

C115647              Column F (definition): The definition appears to be adapted from the TMF RM. Please state [Adapted from TMF-RM].

 

C115605              Column C (preferred term): The content of this subcategory is not exclusively for trial start up e.g. training materials, trial management communications.

 

                            Column F (definition): The content of this subcategory is not exclusively for trial start up e.g. training materials, trial management communications.

 

C115656              Column C (preferred term): The inclusion of the word ‘documents’ in unnecessary and not included elsewhere for category and subcategory terms. Propose changing to ‘Trial Management Communications and Tracking’.

 

C115658              I agree with the content proposed.

 

C115547              Column C (preferred term): I recommend including the term “Trial Management” for consistency with filenotes in other categories i.e. ‘ Trial Management Filenote’.

 

                            Column D (synonym): The term ‘Note to file’ is a commonly used synonym. I would recommend inclusion.

 

                            Column E (abbreviation): Include ‘Mngt’ for consistency.

 

 

Eldin Rammell

Managing Director, Rammell Consulting Ltd.