(a) The investigator has overall responsibility for ensuring the accuracy and completeness of data entry. The investigator must ensure that the observations and findings are recorded correctly and completely in the case-report forms (CRFs) and signed by the responsible person designated in the protocol.
When conducting a study and using CRFs to report clinical trial data to the sponsor, the investigator must also ensure that the routine requirements for recording of data in the source documents (e.g. hospital and laboratory records, consultation files) are met, particularly those relating to the treatment given to the subject and adverse events.
(b) If trial data are entered directly into a computer, there must always be an adequate safeguard to ensure validation, including a signed and dated print-out and back-up records. Computerized systems should be validated and a detailed description for their use be produced and kept up-to-date.
(c) All corrections to CRFs and to raw data must be made in a way which does not obscure the original entry. The correct data must be inserted with the reason for the correction (if not obvious), the date, and the initials of the investigator or authorized person. For electronic data processing, only authorized persons should be permitted to enter or modify data in the computer and there should be a record of changes and deletions. If data are altered during processing, the alteration must be documented.
(d) Laboratory values with normal reference ranges, preferably together with the specificity and sensitivity of the methods used, should always be recorded on the CRF or be attached to it. Values outside a clinically accepted reference range or values that differ significantly from previous values must be evaluated and commented upon by the investigator.
(e) Data other than those required by the protocol may appear on the CRF, provided they are clearly marked as additional or optional findings, with an explanation of their significance.
(f) Units of measurement must always be stated, and conversion of units must always be indicated and documented.
(g) The final report of the trial should be drawn up as defined in the protocol. The report should be signed by the sponsor, monitor and investigator(s) as well as the responsible statistician, in accordance with the applicable regulations.
(h) For a period of time defined by national regulations, the investigator should maintain a confidential record to allow the translation of the unambiguous code used to conceal the identity of the individual subjects in the trial (subject identification code). The investigator may submit the subject identification code list to the drug regulatory authority after the trial, together with the final report, according to national regulations.
(i) The investigator should ensure that the subject’s participation in the clinical trial is clearly marked in his or her medical records.