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<B>Objectives.</B>

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INTERNATIONAL CONFERENCE
ON HARMONIZATION PRINCIPLES
OF GOOD CLINICAL PRACTICE

1. Clinical trials should be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki, and that are consistent with GCP [good clinical practice] and the applicable regulatory requirement(s).

2. Before a trial is initiated, foreseeable risks and inconveniences should be weighed against the anticipated benefit for the individual trial subject and society. A trial should be initiated and continued only if the anticipated benefits justify the risks.

3. The rights, safety, and well-being of the trial subjects are the most important considerations and should prevail over interests of science and society.

4. The available nonclinical and clinical information on an investigational product should be adequate to support the proposed clinical trial.

5. Clinical trials should be scientifically sound, and described in a clear, detailed protocol.

6. A trial should be conducted in compliance with the protocol and amendment(s) that have received prior institutional review board (IRB)/independent ethics committee (IEC) approval/favorable opinion.

7. The medical care given to, and medical decisions made for, subjects should always be the responsibility of a qualified physician or, when appropriate, of a qualified dentist.

8. Each individual involved in conducting a trial should be qualified by education, training, and experience to perform his or her respective task(s).

9. Freely given informed consent should be obtained from every subject prior to clinical trial participation.

10. All clinical trial information should be recorded, handled, and stored in a way that allows its accurate reporting, interpretation, and verification.

11. The confidentiality of records that could identify subjects should be protected, respecting the privacy and confidentiality rules in accordance with the applicable regulatory requirement(s).

12. Investigational products should be manufactured, handled, and stored in accordance with the approved protocol and amendment(s).

13. Systems with procedures that assure the quality of every aspect of the trial should be implemented.


ESSENTIAL ELEMENTS OF A
CLINICAL TRIAL PROTOCOL

Clearly specify the objectives of the study, including primary and secondary objectives.

Type of Trial. Describe the type of design of the clinical trial (e.g., single or multicenter, type of blinding, parallel or crossover).

End Points. Describe the primary and secondary end points.

Patient Population. Describe the population to be studied, enumerating all inclusion and exclusion criteria.

Investigational Device. Describe the device to be studied and how the treatment will be administered with the device.

Control Group. Describe the nature of the control to be used in the study (e.g., randomized, concurrent, control; historical control; or patient as own control).

Assignment of Intervention. State how patients will be assigned to each study group (e.g., via randomization).

Sample Size. State the number of subjects planned to be enrolled and provide a statistical justification for the proposed sample size.

Masking. Discuss masking or blinding of patients and health-care providers.

Study Procedures. Enumerate all procedures, examinations, and other evaluations to be conducted at each visit.

Study Assessments. Specify safety and efficacy parameters, including the methods and timing of such assessments.

Study Duration. State the projected length of recruitment and patient follow-up periods.

Adverse Device Effects. Enumerate the nature and frequency of all anticipated adverse device effects.

Data Analysis Plan. Prospectively formulate a data analysis plan, including a description of the statistical methods to be used and the timing of any interim analyses.

Study Monitoring. Describe the procedures for monitoring patient and investigator compliance.

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