What should I prioritize during a CRO lead migration?

Home Forums TMF Management, Content & Processing What should I prioritize during a CRO lead migration?

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    • #3738
      Katie Kelly

      My CRO is migrating my eTMF into a new solution in 2021, and to my knowledge the CRO has no SOPs in place to guide the migration. What are my primary concerns or things to look out for (eg, how to manage nomenclature, documents going missing)?

      It seems like it is a straight forward process, that could easily be riddled with issues.

      Thank you!

    • #3760
      Richard Golden

      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

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