Test plan (clinical study)
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 .
Web links
- Sample test plan of the ethics commission of the medical faculty of the Georg-August-Universität Göttingen ( Memento from November 25, 2011 in the Internet Archive ) (PDF file; 49 kB)
- Probanden.info website with glossary