13 CASE REPORT FORMS Per ICH GCP Guideline 6.4.9, the Protocol should have a description of the trial design that should include: identification of any data to be recorded directly on the CRFs (i.e., no “The prior written or electronic record of the data) and to be considered source data.” Therefore, if any of the forms will be used as source documents, this must be stated in the Protocol. All documents must have a Version number and date. Paper CRFs: Include in this section a blank copy of all final (actually used) versions of case report forms (CRFs), subject diaries, or other forms used for entering study data, including forms for screening study subjects. Include full copies of all blank versions - newest in front. eCRF Studies: All versions (actually used) of the Source Document Workbook that is provided by the Sponsor must be kept in this section. Dated documentation of all changes to the database during the active period of the must be maintained. At the end of the trial, a CD, disk, or hard copies of all final versions of case report forms (eCRFs) must be added to the file.
13 CASE REPORT FORMS Per ICH GCP Guideline 6.4.9, the Protocol should have a description of the trial design that should include: “The identification of any data to be recorded directly on the CRFs (i.e., no prior written or electronic record of the data) and to be considered source data.” Therefore, if any of the forms will be used as source documents, this must be stated in the Protocol. All documents must have a Version number and date. Paper CRFs: Include in this section a blank copy of all final (actually used) versions of case report forms (CRFs), subject diaries, or other forms used for entering study data, including forms for screening study subjects. Include full copies of all blank versions - newest in front. eCRF Studies: All versions (actually used) of the Source Document Workbook that is provided by the Sponsor must be kept in this section. Dated documentation of all changes to the database during the active period of the must be maintained. At the end of the trial, a CD, disk, or hard copies of all final versions of case report forms (eCRFs) must be added to the file.