TheInformed Consent Form (ICF)is the document that explicitly describes what study subjects can expect regardingdata disclosure, privacy, and confidentialityduring and after participation in a clinical trial. According toICH E6 (R2) Good Clinical PracticeandFDA Human Subject Protection Regulations (21 CFR Parts 50 and 56), participants must be fully informed about how their personal and clinical data will be collected, used, stored, and shared — both during the study and in any subsequent data-sharing or publication activities.
TheGCDMPreiterates that clinical data managers must ensure that all data handling practices align with the privacy commitments made in the ICF. This includes compliance withdata protection regulationssuch as HIPAA (in the U.S.) and GDPR (in the EU). The ICF defines the permissible scope of data use, ensuring ethical management and subject protection.
Documents like theprotocolordata sharing planmay outline procedures and responsibilities but do not directly inform participants of their rights and data use expectations. Only theICFis designed for that ethical communication purpose.
Reference (CCDM-Verified Sources):
SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Ethics, Privacy, and Data Security
ICH E6 (R2) Good Clinical Practice, Sections 4.8.10 & 4.8.12
FDA 21 CFR Part 50 – Protection of Human Subjects, Informed Consent Requirements
