The necessity to upgrade case report forms (CRFs) happens often during the course of a clinical trial. As a result of advancement in the world of electronic data capture methods, the requirement for Electronic case report forms (eCRFs) has been increased significantly. One should analyze the root cause to such updates in electronic case report forms to acquire efficient knowledge about the migration of case report forms to electronic case report forms. Factors such as protocol amendments, optimized changes made to the eCRF specification requirements and the logic responsible for the automation of the entry or verification of data during the course of study substantiate the needs to migrate to eCRF.
Migration to Electronic Case report forms also involves complicated procedures and could be time-consuming in cases that involve the creation of a new version of the eCRF and move the subject records to that particular version. In order to reduce such additional burden to not only sponsor and CRO personnel but also sites an imperative approach is designed to keep relevant electronic Case Report Forms (eCRF) updates and migrations to the necessary minimum.
While a dedicated study is actively collecting subject data eCRF design complexity correlates with the number of migrations including already approved migrations and its performance. Some kind of correlation exists to keep up our expectation as confirmed by the collected data. When an eCRF design becomes more complex, it happens to be equally tough to plot the graph manifesting the likeliness of an update which is required to be done during the course of the study. With respect to the number of unique eCRF pages, edit checks (custom and standard) and derivations included in the design, an eCRF design is altered and optimized to regulate design complexities.
Based on the corresponding eCRf designs the average number of migrations and findings obtained as a result of implementing necessary eCRF pages and datasets will be included in the design. The time factor plays an important role in the determination of the efficiency of an eCRF design. Sometimes it becomes hard to maintain the appropriate time intervals between the validations of designs that account for the migration of CRF to eCRF. In some other cases, few number of subordinate factors reel down to fetch valuable results and thus keeping the time intervals intact. It has become evident that the things affecting eCRF design efficiencies will be based on the study planning efficiencies upon which the responsibilities will be assigned. While the course of study is in progress, the burden of the need for migrations and lessening burden on study teams and site staff shall be reduced by having a lower eCRF design complexity that will lead to positive downstream effect.
Irrespective of the type of data entered for the subject or the means of migration you use the existing information will not be removed or deleted from the database as a result of CRF version migration. In the case where the previous versions of a CRF had more items than the new CRF to which data was migrated the previously entered data may not be displayed on eCRFs extracts. Some of the vital factors involved in the construction of algorithms required for the migration of CRF to eCRFare CRF version, data validation, audit log, E-signature status, SDV status, Extracts, response sets and batch CRF migration. Though, CRF has only one version the reassign CRF version will be displayed. Original CRF version and target CRF version will be taken into account to calculate the CRF version migration events that are reflected in the audit log with corresponding information. Once the CRF version migration is done the SDV for migrated CRFs will be reset to “need source data verification”.