The permanently increasing complexity of European and international requirements, as well as increasing awareness for quality control/assurance in clinical trials, lead to the understanding that professional data management of the highest quality is a must.
Only a high-quality database can provide good and reproducible results from statistical analyses.
- Development of the “Data Management Plan” (DMP)
- Development of the “Data Validation Plan” (DVP)
- Database set-up
- Data entry / data import
- Data query management
- Plausibility check and quality control of the database
- SAE reconciliation
Your study data can be captured either conventionally or electronically (Electronic Data Capture – EDC). For conventional data collection “hardcopy CRFs” (case report forms) are created. In a second step data is entered into a specially adapted database (double or single data entry).
Methods of Data Collection
Prior to the start of the study, parameters to be collected and the data management strategy must be defined and documented in the protocol. We can help you to create a logical and correct data structure.
Particularly for data entry of a large number of parameters, the structure of the database forms is essential for secure and rational data collection. In a well-designed database form, this is done by choosing from predefined attributes and selection criteria. Databases thus create an optimal data structure and prevent the need for time-consuming restructuring at the end of data collection. In addition, professionally created databases can prevent data entry errors, like contradictory or implausible values, through the implementation of automated checks. In case of manual data entry we recommend double data entry. For this concept data is entered independently by two different employees. Deviating entries are then reconciled with the original documents using the 4-eyes principle.
Microsoft Access, for example, can be used as a database.
We would be pleased to design and set-up the databases for your projects. Of course we pay special attention to cost-effective and secure data collection as well as targeted query and analysis possibilities.
We have created test databases which can be used to demonstrate the quality of our system!
Paper Case Report Forms (CRFs)
Paper CRFs are designed for handwritten data entry. They are cheap to produce and can easily be copied and faxed. Neither computer access nor passwords are required, furthermore they are not stationary and therefore more flexible for use. In case of amendments during the conduct of the study, these can be implemented relatively easy and quickly. On the other side, a lack of automated support and checks, as well as the need for an additional data transfer create possible sources of errors and therefore represent some of the disadvantages of a Paper CRF.
Electronic Case Report Forms (eCRFs)
The creation of an eCRF is more complicated and complex. It must be validated and every data correction must be traceable (audit trail). It must be ensured that only authorized personal has access to the program and that regular automatic data backups are carried out to meet the following requirements:
- ICH GCP E6
- FDA-21 CFR Part 11
In order to use an eCRF in a study, access to computers and the Internet is mandatory. In addition, study staff has to be trained on the eCRF. Furthermore, also phone support is often necessary.
The eCRF (“Marvin”, XClinical) mainly used by our company for clinical trials fulfils all requirements. In addition, direct data collection (DDC) and patient-reported outcomes (PROs) are also possible. DDC refers to direct data import (e.g. laboratory / ECG data, electronic patient questionnaires / diaries) via electronic devices. PRO means that data is recorded directly by the patient on paper or in an electronic system. This includes all types of questionnaires and diaries.
Especially for non-interventional studies, registry studies, retrospective studies or other research projects we also offer the very attractive alternative “ShareCRF”. The servers are hosted in the European Union and the system also meets all of the above mentioned requirements.
No matter which kind of data collection is required by you, we are happy to create the right system for your project and therefore the basis for high data quality.
Both CRF and eCRF must be easy to handle and understand for several parties. Our wide-ranging service portfolio allows our experienced staff to take all possible considerations into account when creating your data collection system.