Competent authorities and marketing authorisation holders should have a quality management system in place to ensure compliance with the necessary quality standards at every stage of case documentation, such as data collection, data transfer, data management, data coding, case validation, case evaluation, case follow-up, ICSR submission and case archiving (see VI.C.6.2.4. and GVP Module I for EU guidance on data quality of ICSRs).

Correct data entry, including the appropriate use of terminologies (see VI.B.8. for ICSRs content and format), should be quality controlled, either systematically or by regular random evaluation. Conformity of stored data with initial and follow-up reports should be verified by quality control procedures, which permit for the validation against the original data or images thereof. With regard to this, the source data (e.g. letters, emails, records of telephone calls, which include details of an event) or an image of the source data should be easily accessible. The whole process should be monitored by quality assurance audits.

Clear written standard operating procedures should guarantee that the roles and responsibilities and the required tasks are clear to all parties involved and that there is provision for proper control and, when needed, change of the system. This is equally applicable to activities that are contracted out to third parties, whose procedures should be reviewed to verify that they are adequate and compliant with applicable requirements.

Staff directly performing pharmacovigilance activities should be appropriately trained in applicable pharmacovigilance legislation and guidelines, in addition to specific training in report processing activities for which they are responsible and/or undertake. Data entry staff should be instructed in the use of the appropriate standards and terminologies (see VI.B.8. for ICSRs content and format), and their proficiency confirmed (see VI.C.6.2.4. for EU guidance on training of personnel for pharmacovigilance). Other personnel who may receive or process safety reports (e.g. clinical development, sales, medical information, legal, quality control) should be trained in adverse events/reactions collection and submission to the pharmacovigilance department in accordance with internal policies and procedures.