Home 
Contact 
Profile 
Videos 
Presentation prepared by Dr Omar Hasan Kasule Sr MB ChB (MUK), MPH (Harvard), DrPH (Harvard) Professor of Epidemiology and Bioethics King Fahad Medical City.
INTRODUCTION
- The protocol is the most important clinical trial document. It is the basic plan and guide for the researcher
- The protocol describes the objectives, design, conduct, and analysis of a study
- CONSORT (CONsolidated Standards of Reporting Trials) 2010 guideline is a good reference for clinical trial design (http://www.consort-statement.org)
PROTOCOL INTRODUCTION
- Protocol Title, Protocol Number, Protocol Date, and Protocol Version.
- Name and address of the sponsor
- Name and title of Principal Investigator, address, and site contact details
- Name and address(es) of laboratories/technical departments or other institutions involved.
- Protocol synopsis: summary/overview of the protocol—The synopsis is a summary of your protocol and
BACKGROUND
- Name and descriptions of the investigational product as well as the justification for the route of administration, dosage, dosage regimen, and treatment periods.
- Statement of compliance with the protocol, GCP, and the applicable regulatory requirements.
- Description of the population to be studied.
- Summaries of potential risks and benefits and why the value of the information to be gained outweighs the risks involved.
- Relevant references to literature and data that provide background for the trial.
OBJECTIVES and PURPOSES
- Primary and secondary objectives of the study.
- Primary outcome measures (endpoints).
- Secondary outcome measures (endpoints).
DESIGN
- Specific Primary and Secondary endpoints are to be measured during the trial.
- Type/design of the trial to be conducted: double-blind, placebo-controlled, open-label, dose-escalation)
- The phase of the study: 1,2,3,4
- Sites of the study: single or multi
- Randomization and allocation
- Stopping/discontinuing rules
- Study procedures: IP administration, visits, evaluations,
- Eligibility, inclusion, and exclusion criteria
- Treatments: (a) Names of products, acquisition, formulation, packaging,
labeling, storage, and stability (b) Dosage, preparation, and administration
of IP (c) Accountability procedures. (d) Procedures for monitoring participant
compliance. (e) Prohibited
medications/treatments before and during the trial. (f) Withdrawal times of concomitant medication
and/or treatments where applicable. (g) Rescue treatments or medications that are
included in the study design.
ASSESSMENT OF
SAFETY:
- Safety parameters
- Adverse Events
- Serious Adverse Events (Expected and Unexpected)
STATISTICS:
- Hypotheses
- Computations
- Interim analysis
- data safety and monitoring board (DSMB)
ADMINISTRATIVE:
- Permission by the host institution,
- Compliance with regulatory requirements and inspections,
- Quality and quality assurance
ETHICS,
REGULATORY, AND LEGAL:
- Statements to follow ethical codes and regulations,
- Reviews by IRB,
- Confidentiality of participant information, maintenance of records
DATA HANDLING
AND RECORD KEEPING:
- How will data be accurate and reliable
- Methods of data capture
- Data review and reports
- How long will documents be kept?
PUBLICATION POLICY
LITERATURE
REFERENCES
Adapted from A Comprehensive and Practical Guide to Clinical Trials Edited by Delva Shamley and Brenda Wright. Pages 6-8. Elsevier 2017