For drug clinical studies validation methodology; creating data collection documents
with unique identifiers; having operators complete security identification verification
before proceeding; having secured operators fill out and sign specified data collection
documents; creating permanent records of the preceding; tracking by unique identifiers
in a local system; uploading to a central system; independently reviewing filled
out signed data collection documents to accept or require clarifications; keeping
permanent read only records of all originally filled out and signed documents;
making document clarification requests; reviewing each response; assigning new
unique identifier links to each version of every revision; iteratively repeating
the above until the documents are clean, and storing and tracking every version
of every document in the central system; providing a monitor query and document
entry history of all changes to all documents to create a secured audit trail.
