Study Planning – Tasks before Start of Study

  1. Creation of all relevant study documents like
    • Study protocol
    • Patient information
    • Investigator’s brochure
    • Case Report Form (CRF)

     

  2. Regulatory Steps like
    • Organization of the evidence of insurance (if a patient insurance is required by law)
    • Application to Competent authority (CA), in Germany either the Federal Institute for Drugs and Medical Devices (BfArM) or the Paul-Ehrlich-Institut (PEI)
    • Application to the responsible ethics committee (EC)
    • Announciation of the study to the respective local authority
    • Contracts with investigational sites and cooperation partners

     

  3. Planning Study Performance
    • Sample size calculation
    • Creation of the Statistical Analysis Plan (SAP) in order to describe the analysis of study dara
    • Creation of the Data Management Plan (DMP) in order to describe processes for data documentation, data control and data cleaning
    • Creation of the Safety Management Plan (SMP) in order define processes for documentation and reporting of all relevant safety events
    • Creation of a Monitoring Plan in order to define the amount and intensity of quality control (e.g. on-site monitoring, remote monitoring, centralized monitoring, risk-baseed monitoring)
    • Creation of the Trial Maste File (TMF)
    • Creation of databases (Safety / Clinical)
    • Validation of electronical systems (e.g. eCRF, eTMF)