CLINICAL STUDY PROTOCOL
Standard size of 5.5” x 8.5” , wire-o bound with laminated covers.
After the objectives and design of a clinical study have been determined, these issues should be documented in the Study Protocol. The Study Protocol is a document containing instructions for all the parties involved in the clinical trial that establish specific objectives for each participant and provide guidelines for their performing.
The Study Protocol should ensure adequate conduction of the clinical trials and collection and analysis of data that are further submitted to the regulatory authorities for review and consideration.
The following sections should be included in the Study Protocol:
- Introduction (brief description of the problem and treatment regimen(s))
- Objectives and purposes of the study
- Study duration
- Number of subjects
- Informed Consent
- Opinion of the Ethics Committee
- Subject selection criteria:
- Inclusion criteria
- Exclusion criteria
- Study Plan
- Study schedule
- Study Visits
- Study Assessments / Procedures
- Definition of efficacy endpoints
- Treatment cycles
- Safety Reporting
- Adverse events (AEs)
- Serious adverse events (SAEs)
- Abnormal laboratory test values
- Abnormal values of other safety parameters
- Withdrawal from the Study
- Clinical laboratory parameters
- Other safety parameters
- Concomitant medications
- Data analysis
The following appendixes may be included in the Study Protocol: Patient Information Sheet/Written information and/or Informed consent form (ICF). Instruction sheet (e.g. for study subjects or study site staff).
The terms, which may be difficult for understanding by study subjects (both medical and law terms) should be avoided in translation of the above mentioned documents containing patient information. If special terms are used in the documents, they should be clarified or explained.