Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 8 - Electronic data handling

Document information
Reference	WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995
Validity area	WHO
Scope(s)	HM
Document name	WHO - Guidelines for GCP for trials on pharmaceutical products*
Version / Revision	1995
Status	Current
Document type	International guideline
Language(s)	EN
Description	World Health Organization WHO Technical Report Series, No. 850, 1995, Annex 3 Guidelines for good clinical practice (GCP) for trials on pharmaceutical products*
Official source	Official link
Restricted access	No
Submitted by	Florian Adragna
Contributors

Reference Details
Module	Module 4 — Unit 4.2.3
Scope	HM
Document part	8 - Electronic data handling
Language	EN
Original entry by	Florian Adragna
Contributors
Tags	Electronic records, Data protection, SOP, Data management plan

Content

8. RECORD KEEPING AND HANDLING OF DATA […] In the event of electronic data handling, confidentiality of the database must be secured by safety procedures such as passwords and written assurances from all staff involved. Provision must be made for the satisfactory maintenance of the database and for back-up procedures.

8.1 Responsibilities of the investigator [...] 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) [...] 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. [...]

8.2 Responsibilities of the sponsor and the monitor a) When electronic data handling or remote electronic data entry systems are employed, the sponsor must use validated, data processing programs with adequate user documentation. A predetermined set of standard operating procedures (SOP) for such systems must be available. Such systems should be designed to allow correction after loading, and the corrections made must appear in an audit file. [...] b) [...] If a computer assigns values automatically when data are missing, this should be made clear.

c) The sponsor must ensure the greatest possible accuracy when processing data. If data are transformed during processing, the transformation must be documented and the method validated. It should always be possible to compare the data printout with the original observations and findings. [...]