Drug Evaluation Committee 2012-44 Difference between Original Data and Original Data
Related classification: clinical trial contracting procedures
Initial release date: February 2013
Revised publication date: Dec. 2021
Question
This question is about the difference between source documents and source data. I understand that "source documents are documents, data, and records that form the basis of a case report" and "source data are all the data necessary to reproduce the factual course of a clinical trial.
For example, in the following case, what do you mean by source documents and source data?
- Blood pressure
- Measured by a nurse with an automatic measuring device; since there is no paper printout, the nurse writes on the worksheet at the time of measurement.
- ECG
- After measurement, there is typing out on thermal paper.
In the above case, is it correct to say that "original data refers to the blood pressure readings and ECG printouts" and "original data refers to the blood pressure readings on the worksheet, ECG printouts, and their certified copies"?
For example, there may be cases where only the judgment result based on the ECG data is entered as "normal" or "abnormal" on the CRF. In this case, is it correct to say that "the source documents are worksheets, ECG printouts, and certified copies of ECGs that describe the results of the physician's judgment based on ECG data," or "the source data are the printouts of ECGs?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Source documents" are defined in GCP Article 2 Guidance 6 as follows
Source documents" are documents, data and records (e.g., hospital records, medical records, laboratory notes, memos, subject diaries or evaluation checklists, administration records, data recorded by automatic instruments, copies or transcripts that are certified by verification to be accurate copies, (e.g., microfiche, photographic negatives, microfilm or magnetic media, radiographs, subject files, and records stored in the drug department, laboratory, or medical technology department involved in the clinical trial.
In addition, "source data" is defined in Guidance 18(12) of the same Article as follows
Original data" means all information recorded in the original records and certified copies of clinical findings, observations and other activities in a clinical trial that is necessary to reproduce and evaluate the factual course of the trial. Source data" is included in the source documents (original records or certified copies thereof).
In other words, the data (information) necessary to reproduce and evaluate the factual course of a clinical trial is called "source data" and the materials (documents and storage media) in which the source data are recorded are called "source documents. Source data includes not only test results but also evaluations (judgment results) of the test results by investigators and others.
Therefore, in the case in question, the source data are "the information printed on the ECG sheet and the results of the investigator's judgment on the ECG" and "the blood pressure readings taken by the nurse," and the source documents are "the ECG sheet (printout) and the worksheet on which the ECG judgment results are recorded" and "the blood pressure readings taken by the nurse. worksheet on which the blood pressure readings were written by the nurse".
Reason for revision of opinion
The opinion has been partially changed in accordance with the issuance of the GCP Guidance (August 31, 2020, Pharmaceutical Affairs Council of Japan, No. 0831-15).