ABSTRACT
When data for a clinical study is captured on paper case report forms (CRFs), that data must be transferred to a database for final storage. We will call the process of transferring it from paper or image into electronic storage “data entry.” Data entry may be entirely manual or it may be partly computerized using optical character recognition (OCR). Regardless of whether there is a computerized step involved in the process, and regardless of the specific application used, the main data entry issues that must be addressed by technology or process, or both, are:
• Selecting a method to transcribe the data • Determining how closely data must match the CRF • Creating processes to deal with problem data • Making edits and changing data without jeopardizing quality • Quality control of the entire process
Transcribing the data Accurately transcribing the data from the CRF to the database is essential. Errors in transcription are usually due to typographical errors (“typos”) or illegibility of the values on the CRF. Companies aim to reduce transcription errors using one of these methods:
• Double data entry with third party reconciliation of discrepancies • Double data entry with second person resolving discrepancies • Single entry with extensive data checking • OCR as first entry with one or more subsequent entry or review
passes
Even after transcription errors are reduced to a minimum, there remains some variation in what an accurate transcription means. Does it mean that the data is an exact duplicate of the values found on the CRF, or are there deviations or variations permitted?
