Document Functions

1. Are there any restrictions on what documents can be merged in Trial Interactive?

Answer: Trial Interactive can merge files up to 3MB per file. The following document types are supported by our Merge function: doc, docx,ppt, pptx and pdf

2. What characters are illegal in exported filenames in Trial Interactive, for archives or exports?

Answer : The following are all illegal characters. Some are illegal on Windows computers, others are illegal in Mac or Linux/Unix computers.

# (pound) [ Valid on Windows only]

% (percent)

& (ampersand) [ Valid on Windows only]

{ (left curly bracket)

} (right curly bracket)

$ (dollar sign)

! (exclamation point)

' (single quotes)

+ (plus sign)

` (backtick)

= (equal sign)

< (less than)

> (greater than)

: (colon)

" (double quote)

/ (forward slash)

\ (backslash)

| (vertical bar or pipe)

? (question mark)

* (asterisk)

3. Question: How does Trial Interactive define key terms with regard to documents and placeholders?

Answer:

  • Unfulfilled Placeholders / Missing: This is the count of placeholders that have been set up required by the eTMF but are still waiting to be collected or marked final. Also referred to as missing required documents, or just 'Missing'.
  • Fulfilled Placeholders: This is the count of placeholders that have been collected, indexed, QC'd, and marked as final in the eTMF.
  • Collected: This is the total count of final, collected documents in the eTMF, which represent not just a count of fulfilled placeholders, but also additional documents and versions collected where more than one document has fulfilled a particular placeholder or eTMF requirement. For non-TMF rooms, this metric may represent non-final documents as well depending on room configuration.
  • Overdue: This is the total count of unfulfilled placeholders that are now past the due date set by a completed Event or milestone in the eTMF. When an Event or milestone is marked complete, the unfulfilled placeholders required by this Event are marked as due to be collected and marked final based on the Event completion date. A Due Date Period is generally added to provide time to collect and mark the documents final, and this period is added to the completion date to determine each document's due date.

4. Question :Why can I sometimes have identical documents with different hash values?

Answer: Some operating systems and word processing programs (ie. Microsoft Word when 'Save As' is used) will add random characters to a document which are not visible when the document is opened for editing but which do result in a different document hash value being generated. This would allow for some documents to appear identical to be stored in the same TI Room.

5. Question : Why do I see a PDF form editable in the TI Original Viewer?
Answer: Some PDFs have form fields that are designed to be edited by a user. These fields are there to allow users to fill out the form if they have a local copy of the document. The fields in these PDFs will still show as editable in the ‘Original’ viewer. This viewer is not technically part of TI, it is built-in to the local browser and shows the document as it actually is, showing it directly in the browser. Anything one does to the document in this viewer is not saved, there is no option to do so. To see the rendition of the final document, one needs to view it using the TI Viewer. Some customers may prefer the original viewer, but the TI Viewer is what is recommended here.