Guidance on Electronic Capture of Clinical Trial Data
Starting with the Electronic Signature Law, the "Guidelines for the Use of Electromagnetic Records and Electronic Signatures in Applications for Approval or Licensing of Drugs" (Pharmaceutical and Food Safety Bureau, No. 0401022, April 1, 2005) and other laws and regulations were established to enable the use of electromagnetic records for documents related to the manufacturing and marketing approval of drugs, which had previously only been allowed in paper form. The "Guidelines for the Use of Electromagnetic Records and Electronic Signatures in Applications for Approval or Licensing of Drugs and Other Products" (Pharmaceutical Affairs Bureau, April 1, 2005) and other laws and regulations have been developed to enable the use of electronic records.
In clinical trials, clinical trial data had been obtained using "paper" case report forms, but recently Electronic Data Capture (EDC) is becoming popular as a method of obtaining data electronically. In addition, central laboratories are increasingly reporting data electronically to sponsors. When clinical trial data is obtained electronically instead of on paper, it is necessary to take measures in advance to ensure that the quality and quality assurance of the data are not inferior to those of paper case reports, and it is desirable to operate based on a common concept.
The Drug Evaluation Committee of the Japan Pharmaceutical Manufacturers Association (JPMA) has established this voluntary guidance with the aim of providing specific requirements when clinical trial data is obtained electronically.
The Committee plans to continue to revise this guidance as appropriate, taking into account advances in information technology and other factors.