2. A research protocol is a document that
describes the background, rationale,
objectives, design, methodology, statistical
considerations, and organization of a
clinical research project.
The protocol contains a study plan on
which the clinical trial is based.
4. 1. General Information
Protocol
Sponsor
Persons authorized to sign the protocol
Sponsor's medical expert
Investigator
Clinical laboratory and other medical &
technical departments & institutions involved
in the trial.
5. 2. Background Information
Investigational product
Summary of findings from nonclinical studies
Risks and benefits
Description
GCP
Population
References to literature and data that are relevant
6. 3. Trial Objectives and Purpose
Hypothesis
Primary Objectives
Secondary Objectives
Potential Risks and benefits
7. 4. Trial Design
Endpoints
Type/design of trial to be conducted
a) Randomization.
b) Blinding
Trial treatment
Duration of subject participation
Stopping rules" or "discontinuation criteria
Accountability procedures
8. 5. Selection and Withdrawal
of Subjects
Subject inclusion criteria
Subject exclusion criteria
Subject withdrawal criteria
9. 6. Treatment of Subjects
Treatment
Medication permitted and not permitted before/during
the trial
Procedures for monitoring
7. Assessment of Efficacy
8. Assessment of Safety
10. 9. Statistics
Statistical methods
Criteria for the termination
level of significance
Procedure for accounting for missing, unused,
and spurious data.
Procedures for reporting any deviation
Selection of subjects
11. 10. Direct Access to Source Data /
Documents
11. Quality Control &Quality Assurance
12. Ethics
Approval
Informed consent
Patient withdrawal / discontinuation.
Trial monitoring.
12. 13. Data Handling and Record
Keeping
14. Financing and Insurance
Funding source
Conflict of interest
Subjects’ payment
Cover for managing adverse events
Study design – causal relationship between exposure and outcome is relevant
Ethical considerations - in new TB drugs I still need to cure the patients
Order is not relevant