Dr Wolfgang Schumacher, Chair of the ECA Data Integrity & IT Compliance Group
During this Webinar you will get to know the principles of Computer Validation (CV) and Data Integrity in the light of GCP requirements.
In clinical trials (CTs), large amounts of data are collected and this data is electronically recorded and processed to a growing extent. Checking Data Integrity (DI) is mandatory and is usually performed by the clinical monitor.
In addition, sponsors contract out an increasing number of tasks in CTs. During inspections of clinical trials, a growing number of deviations from GCP standards related to contractual arrangements with vendors of electronic systems and related procedures have been identified by the inspectors.
In order to clarify these issues, the EMA has recently published a
„Notice to sponsors on validation and qualification of computerized systems ". In this Notice, the EMA clearly states:
- The sponsor is ultimately responsible for the validation of the computerized system (CS) and for providing adequate documen-ted evidence,
- Failure to document the validated state of a CS is likely to pose a risk to Data Integrity,
- It is not acceptable to use CSs in CTs for which the Validation status is not confirmed or appropriately documented
Employees involved in designing, conducting, evaluating, and documenting of clinical trials, like Validation manager, QA manager, project manager, data manager, and statisticians. Pharmaceutical companies, sponsors, contractors (for example CROs, analytical labs) and vendors for electronic systems (including hosting partner). Inspectors responsible for performing GCP inspections and needing to understand and assess data integrity.
For our webinars, we use Cisco WebEx, one of the leading suppliers of online meetings. At https://www.webex.com/test-meeting.html
you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in. Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.
- New EMA GCP Computer Validation Guidance – Impact on ongoing validation projects?
- Emphasis of validation in the GCP area
- Data Integrity in clinical trials
- CRF (Case Record Form)
- ICF (Informed Consent Form)
- Are the EU GDPR rules applicable?
- Concerns of the Regulators – Inspection findings
Recording from 08.07.2020
Duration of recording: about 1,5 h.