Dr. Rolf Siegel

Independent consultant for Clinical Quality Assurance Service and GCP Training (e.g., for FORUM Institute). Former senior director quality assurance in a Contract Research Organization.

Fifteen years of clinical trials experience in the pharmaceutical industry including staff management.

Twenty years of clinical research experience in a Contract Research Organization, mainly in Global Clinical Quality Assurance, e.g., audits of clinical investigator sites, vendors (organizations, labs, drug depots etc), including staff management and GCP training.

International coverage of auditing activities:

• All over Europe from West to East
• Americas: USA, Argentina
• Asia: China, Taiwan, Korea

Education:

Ph.D. in Chemistry and Pharmacology (Dr. rer. nat.)
Max-Planck-Institute for Medical Research, Heidelberg, Germany
M.Sc. Chemistry (Dipl.-Chem.)
Ruperto-Carola-University, Heidelberg, Germany

Services:

• Monitoring of clinical investigational sites internationally
• Audits: General objectives of a clinical quality assurance professional is the promotion of ongoing quality awareness and continuous improvement of clinical drug development by performing audits on various aspects in the management of clinical trials all around the globe, e.g.,
  • Clinical investigational sites
  • Clinical vendors of critical services and preferred providers (labs, drug depots etc), pre-qualification and/or compliance for clients
  • Client offices (organization audit)
  • Trial Master File (TMF)
  • GCP consulting and training

Example for Clinical Investigator Site Audits

If not directed or for cause, investigator site audits are used to identify important protocol and GCP non-compliance, and they may include an assessment of CRA monitoring performance. As an example, depending on the scope of an investigator site audit typically includes time for preparation, Trial Master File in-house review and time for audit activities at the clinical investigator site such as, for example:

• Reviews of a sample of the site-specific Trial Master File (TMF) or electronic Trial Master File (eTMF)
• Reviews of a sample of general Trial Master File sections, such as regulatory, central ethics committee, trial protocol and CRF, central laboratory, investigational product, monitoring guidelines, and safety reporting
• Discussions with the principal investigator and other key staff
• Reviews of a sample of the investigator site file documents:
• Reviews of signed and dated informed consent forms for the screened and randomized subjects
• Partial reviews of CRFs and source documents for a sample of subjects
• Reviews of serious adverse events
• Assessments of investigational drug storage conditions and review of drug accountability for a sample of subjects