A prospective observational study to assess effectiveness of the training and risk minimisation measures recommended for the usage of the diagnostic agent NeuraCeqTM in the post-authorisation clinical situation: A post-authorisation safety study (PASS)

ENCePP Code of conduct

No

Data sources

• Data sources (types):
  Other
• Data sources (types), other:
  Visual assessment results of 20 PET scan cases previously assessed by two independent experts (to achieve the first goal, the primary objective 1 - effectiveness of training material).Answers of a multiple choice questionnaire (to achieve the second goal, the primary objective 2 - monitoring the effectiveness of risk minimisation measures.

Use of a Common Data Model (CDM)

• CDM mapping:
  No

Data quality specifications

• Check conformance:
  Unknown
• Check completeness:
  Unknown
• Check stability:
  Unknown
• Check logical consistency:
  Unknown

Data characterisation

• Data characterisation conducted:
  No