Training

Ongoing training is integral to stay current on best practices and regulatory changes.

Regulatory Requirements

According to ICH/GCP and according to regulatory requirements from FDA, BfArM, INVIMA, and other international regulatory authorities:

  • Medical Device Law & MPG Training (Germany)
  • ISO14155
  • We are authorized to provide basic GCP, MPG/Drug Act training.

Study Site Training

…face to face as much as possible

  • The compliance of the study site is the most important tool for a successful study conduct. That being said, our team always endeavors to train the site in person.

Protocol Compliance

At Study Start-up…

  • Intensive training on the study-specific protocol is required to maintain protocol compliance in order to avoid protocol deviations and/or violations.
  • Staff are encouraged to discuss individual questions and concerns through the process.
    • Protocol presentation with a focus on in-/exclusion criteria
    • Study logistics & reporting
    • Importance of clear, accurate source documentation
    • Case report eCRF completion

Safety

A Key End Point of Clinical Studies…

  • One of the most important items to discuss is safety regulatory requirements.
  • Staff will be trained and/or retrained during every site visit to ensure compliance.
    • Clearly Defining Adverse Experiences (SAE, SUSAR, SADE, UADE, ADR)
    • Reporting of Adverse Experiences
    • Expected Timelines for Reporting of Events

CRF Completion

Assuring Data Integrity…

  • To avoid discrepancies in the database, the site will be instructed on how to properly complete entries into the CRF, whether it is paper or electronic CRF. Additionally, they will learn how to make the appropriate corrections when necessary, based on good source documentation.
  • The best and most efficient way to ensure data integrity is to have a face-to-face training to build personal relationships and to assess the site’s comprehension and understanding.