4 Data protection, confidentiality and retention 4.1 A validated system is in place to ensure R Yes / No □ □ privacy, when electronic subject’s communication tools are used as part of the eIC interview process (ICH-GCP 2.11) 4.2 A validated system is in place to ensure R Yes / No □ □ that the data is stored subject’s securely when tools are used as part of the eIC interview process (ICH-GCP 2.11) 4.3 A system is in place to ensure that the R Yes / No □ □ original eIC and the signed paper consent form are archived appropriately and securely for 10 years* at study end and that it can be retrieved easily, if necessary (e.g. by archiving the operating system and applications). *15 years for research projects with medical devices 5 Amended eIC
4 Data protection, confidentiality and retention 4.1 A validated system is in place to ensure subject’s privacy, when electronic communication tools are used as part of the eIC interview process (ICH-GCP 2.11) R Yes □ / No □ 4.2 A validated system is in place to ensure that the subject’s data is stored securely when tools are used as part of the eIC interview process (ICH-GCP 2.11) R Yes □ / No □ 4.3 A system is in place to ensure that the original eIC and the signed paper consent form are archived appropriately and securely for 10 years* at study end and that it can be retrieved easily, if necessary (e.g. by archiving the operating system and applications). *15 years for research projects with medical devices R Yes □ / No □ 5 Amended eIC
Guidance_e_consent_e.docx