GCP: study integrity – trail integrity

Data integrity requirements define the assurance that records are accurate, complete, intact and maintained. These requirements are basic GCP requirements as defined in ICH E6.

CCS offers detailed GCP data integrity checks and assessments for the Study Design and Reporting, eTMF, eCRF, statistical applications, and Study Reports, based on the electronic data flow for the entire study process. Additional monitoring techniques, such as routine review of data as they are submitted, are possible for studies that use electronic CRFs.

Periodic Evaluations of the validation and security status of the CTMS can supplement the service range, including Supplier Audits (CROs, Vendors, Hosting) and/or Quality Agreements.

Each Study needs to have an appropriate Data Governance System: Study Integrity – Trail Integrity – Data Integrity. Start your independent trail review regarding data integrity today.