Standard Operating Procedures - SOP-24

Standard Operating Procedures (SOP)SOP-24Clinical Data Management, Paper orElectronic Format

SOP-24Clinical Data Management, Paper or Electronic Format• Objectives– Define the different stages of management of clinical dataentered onto the CRFs, whether on paper or electronically.This SOP describes the stages of collection, capture andstorage of data, as well as quality control and corrections toclinical data collected during the study.– Ensure that the collection, follow-up, control andconfidentiality of all clinical data entered in a CRF, paper orelectronic, conforms to the principles of the ICH and the lawsand regulations in force. In order to achieve this goal, it isimperative that the system used for applicable capture andprocessing of data is validated, and that the databases inwhich clinical data are stored accurately represent thesubject’s data.

SOP-24Clinical Data Management, Paper or Electronic Format• Generalities– The sponsor-investigator who is responsible for themanagement of clinical data for the study should:• Develop instructions in the case where data managementis performed directly by a service within the institution• Manage authorizations for access to clinical data• Ensure the protection and security of data• Ensure confidentiality of the identity of subjects

SOP-24Clinical Data Management, Paper or Electronic Format• Generalities– The sponsor-investigator who is responsible for themanagement of clinical data for the study should:• Precisely enter data from the CRF• Ensure that the electronic system used for clinical datamanagement is valid• Retain the original or a certified copy of the certified databackup• Confidentiality and Direct Access to Clinical Data– Document identifying person authorized to access

SOP-24Clinical Data Management, Paper or Electronic Format• Collection and Clinical Data Capture– Study information should be recorded, processed, stored,interpreted and verified– Data capture can be done by single or double data entry– A system for tracking data entry and modification should beavailablePaper CRFsElectronic CRFs

SOP-24Clinical Data Management, Paper or Electronic Format• Quality Control and Modifications to Clinical Data– Quality control systems should be:• Applied to each stage• Established during the data capture• Applied once data capture is completed– CRF modifications• Data clarification form (DCF)– Tracking system

SOP-24Clinical Data Management, Paper or Electronic Format• Storage of Clinical Data– In the case of a clinical study using a drug or medical device:• 25 years– In the case of a clinical study without drug or medical device:• « calendrier de conservation »

SOP-24Clinical Data Management, Paper or Electronic FormatQuestions ?