Ensure data entry is as complete as possible. If data are unavailable then write applicable’ or on the CRF. Do not leave blank ‘unknown’, ‘not ‘missing’ spaces. Do not create additional fields on the CRF i.e. Only provide information which is asked for. Ensure that all entries are legible. Corrections should be made by crossing through the incorrect entry with a single line so that the original entry is still readable. Enter the correct data. Initial and date the correction. Never use correction fluid or obliterate entries made on the CRF. CRFs should be stored in a secure location during the course of the and archived when the study has finished. See SOP: Archiving of Essential Documents. When all entries and corrections are deemed to be complete, the CRF must be signed by the principal investigator (or designee) to assert that they believe it to be complete and correct. Where Forms/Templates are referenced in the text, the numbers and titles are listed under this section. This section is used to list all controlled internal references (e.g. SOPs) and external references referred to within the text of the SOP only. Internal References Design and Development of Case Report Forms Archiving of Essential Documents External References ICH Harmonised Tripartite Guideline for Good Clinical Practice. Where the SOP is the initial version: The SOP number is recorded. version” is noted in the section. “Initial ‘Significant’ Where replacing a previous SOP: The Effective Date for the previous version is recorded against that version in the table.
Ensure data entry is as complete as possible. If data are unavailable then write ‘unknown’, ‘not applicable’ or ‘missing’ on the CRF. Do not leave blank spaces. Do not create additional fields on the CRF i.e. Only provide information which is asked for. Ensure that all entries are legible. Corrections should be made by crossing through the incorrect entry with a single line so that the original entry is still readable. Enter the correct data. Initial and date the correction. Never use correction fluid or obliterate entries made on the CRF. CRFs should be stored in a secure location during the course of the and archived when the study has finished. See SOP: Archiving of Essential Documents. When all entries and corrections are deemed to be complete, the CRF must be signed by the principal investigator (or designee) to assert that they believe it to be complete and correct. Where Forms/Templates are referenced in the text, the numbers and titles are listed under this section. This section is used to list all controlled internal references (e.g. SOPs) and external references referred to within the text of the SOP only. Internal References Design and Development of Case Report Forms Archiving of Essential Documents External References ICH Harmonised Tripartite Guideline for Good Clinical Practice. Where the SOP is the initial version: The SOP number is recorded. “Initial version” is noted in the ‘Significant’ section. Where replacing a previous SOP: The Effective Date for the previous version is recorded against that version in the table.
sop_template_for_case_report_form_completion.docx