The protocol should include information such as:
- The Aims and objectives of the trial
- The background of the trial
- The rationale for doing the trial
- Design and methodology
- Description of Inclusion / Exclusion Criteria
- Dosage levels
- Efficacy / Safety Variables
- Frequency / duration of treatment
- Frequency and types of a laboratory investigations
- Approvals
- Trial supplies
- Study Records ( Source document verification frequency )
- Study Auditing / Inspection
- Report Writing and Publication
- Investigators consent / Agreement
- Study Flow chart
- Declaration of Helsinki
- Reporting of Adverse Events
- Serious Adverse Event Reporting Form
- Patient Consent Form
- Patient Information Sheet
- References