Test plan (clinical study)

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The test plan - alternatively as a test report, study protocol (of English study protocol ) or curriculum called - is an important part of a scientific study, in particular a clinical trial . The most important features of the research project are described and specified in the test plan.

These features include:

  • the state of research on which the study is based (see state of science )
  • the goals of the study or the hypotheses to be checked (endpoints, target criteria)
  • the study design (e.g. randomized controlled study , double crossover )
  • the type of treatment (study intervention, dose or dosage schedule of the study medication, etc.)
  • the inclusion and exclusion criteria for subjects to be recruited (gender, age, health status, previous illnesses, etc.)
  • Termination criteria for test subjects (e.g. pregnancy that has occurred)
  • the measured values ​​to be collected (e.g. blood values, liver values, special measured values ​​of biomarkers , etc.)
  • the ward planning (days / periods where measurements are applicable)
  • the statistical evaluation methods
  • the client (sponsor) of the investigation (pharmaceutical company, health authority)
  • Name and address of the participating test centers (medical practice, university clinic)
  • Name and address of the participating investigators (investigator, investigator, clinical monitors )

The Medicines Act , the Medical Devices Act and the Helsinki Declaration provide that a test plan must be drawn up prior to any medical research project on humans. The preparation takes place in coordination with the respective test centers and ethics committees involved . The approval to conduct a study is essentially based on the test plan submitted (any subsequent deviations are also subject to approval by the institutions mentioned).

The so-called test sheet ( case report form ), in which the study-relevant data of the patient / test person is recorded in pseudonymised form, must be separated from the test plan .

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