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most likely 2.2.1 if the diary is being filled out by patient. but 2.2.2 if it’s being filled out by site coordinator or other staff
Speaking only to my own experience, track changes docs are uploaded only if they were part of a specific regulatory or IRB submission package (and especially if the RA or IRB requested the track changes docs). Of course, a sponsor can use their own discretion beyond those two circumstances.
Speaking from personal experience, a study level budget should be uploaded only at the study level (most likely 1.1.2).
At the site level, I have seen local site budgets attached to a CTA at 5.2.12, but not the overall study budget.
Whatever we uploaded, we always made sure that no proprietary financial information was included (from sponsor, Investigator, CRO, vendor)
for both questions – are you asking about the approval documentation being distinct from the approved documents?
if I understand you correctly, the IRB approval letter/form should go in 4.1.2
while the actual approved documents go in their respective Zone 2 folders (2.1.4 for protocol amendment and 2.2.3 for ICF)
it would be helpful to clarify exactly what you’ve received from the IRBby study supplies, do you mean IP or non-IP? if it’s IP, I would use 6.1.5, if it’s non-IP, i would use 6.5.3
as for the ETDRS and visual acuity logs, it may be a toss-up between 5.4.11 (source data) and 5.4.13 (eligibility).
I’ve never seen a stipend accountability log in the TMF – if the sponsor insists on including it, I’m thinking 5.4.7
do you have two separate documents – an approval and an acknowledgment of receipt?
if I understand you correctly the approval would indeed go in 4.1.2 but the acknowledgment would go in 4.1.1 with the submissionsplease elaborate on what you mean by “APR ack”?
We have included local lab information in the TMF at the site or country level – normal ranges, accreditation certificates, along with the central lab information at the study level.
I understand those who express concern about “duplicating” the ISF in the TMF but my understanding is that an inspector may not be satisfied with a note to file repeatedly pointing to the ISF – not sure there is a “correct” answer
While these emails can go in Relevant Communications, we prefer to place them in artefact 5.4.3 along with the actual monitoring reports.
I assume you are talking about the Continuing Review APPROVAL cover letter from the IRB? I generally put them in 4.1.2 with any approval forms.
If this assessment is taking place AFTER a site has been selected, then 5.4.5 seems appropriate.
If this assessment is taking place BEFORE a site has been selected, then 5.1.3 seems appropriate.
i assume you are talking about Expected Document Lists in Veeva Vault? We have a few templates but it’s impossible to create specific template for every single study. So it’s important to manipulate the EDL by designating what is required or not required. This manipulation takes place at all three levels. (Of course, we may upload documents into the library that are not reflected in the EDL, but those are few and far between)
The translation process could be explained in a Note to File, signed by the Country Study Manager (or similar person in charge of the study for that country).
I would consider the following:
Nomenclature (naming convention)Placement (are documents in the correct category/subcategory)
Document Dates (do they use date created or version date)
Business Version (are all versions present, if applicable)
Missing documents (if there is an IRB approval, there should be a submission)
Mapping process (if a document is at 4.1.2 in their system, will it still be at 4.1.2 when transferred to your system)
Proper scanning (are pages in correct order, are they cut off, are they legible)
Are documents in PDF or native format (depending on your sponsor requirements)
Are there are any password-protected documents
Are there documents with other documents embedded in them
Do emails have attachments connected or separate
Alejandra,
If you are using Veeva Vault, the document name that’s automatically generated by the system provides a solid guide to naming conventions. The naming conventions need to be succinct yet still descriptive. One rule of thumb is “a person who knows absolutely nothing about this study should be able to read the name and know what the document is without opening it”My experience is that password protected documents should never be filed – an inspector or auditor should never be in the position of requesting a password. Instead, a PDF version of the document is uploaded on its own accord.
if the password-protected doc is embedded into another doc, i.e. Word meeting minutes with an embedded Excel spreadsheet or Powerpoint presentation, the hyperlink for the embedded doc can be opened by anybody with TMF access, including an inspector/auditor.
Hope this helps.