Audits in Clinical Research

PMK offers the following Audit Services (see also SOPs)

Pre-Trial Audit: Study documents (protocol, CRF, patient information, patient informed consent)

In-house Audit c/o Sponsor/CRO: compliance with SOPs, Trial Master File, prerequisites for start of the study, monitoring or in-process control, handling of test preparations/products, commitments and contracts, qualification of personnel, archiving

On-site Audit trial centre/laboratory etc.: facilities, patient pool, Investigator‘s File, handling of test preparations/products, originals of patient informed consent forms, data verification (SDV), validation of systems and/or analytical methods, as appropriate, compliance with the protocol, AE/ADR reporting system, especially SAE/SADR, monitoring, archiving

Data Base Audit Biometry: system audit of H/W and S/W, validation of data base systems, Data Management Plan, SOPs, data entry, determination of the failure rate based on a 10% simple random sample (CRF vs. Patient Data Listings; procedure proposed by W. COCHRAN [Sampling Techniques, New York 1977, pp. 64]), check of in- and exclusion criteria, SAE, AE, ADR, withdrawals according to AE, laboratory values deviating from reference

Clinical Trial Report Audit: check on completeness and consistency, incl. all appendices, formal and legal requirements (SOPs, drug acts, ICH ...), typography, consistence, congruence with the protocol and statistical tabulations

Audit Report: sponsors of Audits were provided with a detailed Audit Report, incl. corresponding checklists and recommendations about follow-up activities

Audit certificate: Quality Assurance Statement, i.e. a declaration of confirmation that an audit has taken place (ICH-GCP 1.7; part of the Appendix of the Clinical Trial Report, 16.1.9).

System audits: CROs, Clinical Research Depts., Biopharmacy, Biometry, Computer Systems, Validation, Drug Manufacturing according to GMP etc.