Documents for audit and inspection

The marketing authorisation holder shall ensure the fulfilment of its pharmacovigilance obligations in relation to the study and that this can be audited, inspected and verified. The marketing authorisation holder shall have the following clearly identifiable documents regarding the PASS available while the study is being conducted and at least for the period legally required:

• a) documents that provide a detailed description of the research methods and objectives of the study, including data collection and evaluation (research plan, setting , etc.), contact information on study sites and investigators.
• b) documents containing data obtained from the study (e.g. questionnaires, adverse event reports, etc.).
• c) documentation on analytical dataset, study results, statistical programmes used for generating data.
• d) interim reports and final study reports.
• e) materials used in the study – e.g. educational materials.
• f) publications that use the findings of the study (final manuscript)

In some cases also other documents may be requested:

• g) study budget with a detailed cost breakdown to individual parts of the study, especially site specific payments.
• h) contracts/agreements between individual parties involved in the study.