The study protocol

Abstract

The essential elements of a protocol are:

• A scientific rationale

• The objectives of the proposed study

• A description of the study population

  • Inclusion and exclusion criteria for recruitment of subjects

  • The number of subjects to be recruited

• A precise description of the procedures that will be performed including:

  • Dosages of drugs that will be administered

  • Volumes of blood to be sampled

  • What will be assayed in these samples

  • Measurements that will be made to assess drug effects

  • The times at which all procedures will be done

  • How long and under what conditions subjects will be studied