Clinical Trials - Protocol

Clinical trial Protocol

The Clinical Trial Protocol is the basis for all clinical trials and gives detailed information about the trial. In other words it describes the course of action of the trial.

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