NINDS Protocol TemplateWord文件下载.docx

1、Sponsor of IND （IDE）:（Official sponsor, i.e., IND or IDE holder, if any. Include IND/IDE # when available）（Any modification to the protocol should be annotated on the coversheet or in an appendix. The annotation should note the exact words that are changed, the location in the protocol, the date the

2、 modification was approved by the Executive Committee, and the date it became effective.）Version 1Month Day, YearTABLE OF CONTENTSPageCLINICAL SITES PARTICIPATING IN THE STUDY .STUDY TEAM ROSTER .PRCIS .1. STUDY OBJECTIVES .1.1 Primary Objective .1.2 Secondary Objectives .2. BACKGROUND . 2.1 Rationa

3、le .2.2 Supporting Data . 3. STUDY DESIGN .4. SELECTION AND ENROLLMENT OF SUBJECTS . 4.1 Inclusion Criteria . 4.2 Exclusion Criteria . 4.3 Study Enrollment Procedures .5. STUDY INTERVENTIONS . 5.1 Interventions, Administration, and Duration . 5.2 Handling of Study Interventions . 5.3 Concomitant Int

4、erventions . 5.4 Adherence Assessment .6. CLINICAL AND LABORATORY EVALUATIONS . 6.1 Schedule of Evaluations . 6.2 Timing of Evaluations . 6.3 Special Instructions and Definitions of Evaluations . 6.4 Off-Intervention Requirements .7. MANAGEMENT OF ADVERSE EXPERIENCES .8. CRITERIA FOR INTERVENTION DI

5、SCONTINUATION .9. STATISTICAL CONSIDERATIONS . 9.1 General Design Issues . 9.2 Outcomes . 9.3 Sample Size and Accrual . 9.4 Data Monitoring . 9.5 Data Analyses .10. DATA COLLECTION, SITE MONITORING, AND ADVERSE EXPERIENCE REPORTING . 10.1 Records to be Kept . 10.2 Role of Data Management . 10.3 Qual

6、ity Assurance . 10.4 Adverse Experience Reporting .11. HUMAN SUBJECTS . 11.1 Institutional Review Board （IRB） Review and Informed Consent . 11.2 Subject Confidentiality . 11.3 Study Modification/Discontinuation .12. PUBLICATION OF RESEARCH FINDINGS .13. REFERENCES . APPENDICESI.II.III. MODEL INFORME

7、D CONSENT FORMCLINICAL SITES PARTICIPATING IN THE STUDYList the name and address of each participating clinical site investigator, including telephone and fax numbers and e-mail address.STUDY TEAM ROSTERList individuals who play key roles in the development and execution of the study, especially tho

8、se who may need to be contacted by the sites during the course of the study. Include address, telephone, fax and e-mail address of each individual listed.PRECISThe following sections should provide a bare-bones outline of approximately 1-2 pages.Study TitleSpecify the full title （and subtitle, if ap

9、plicable） of the study.ObjectivesSpecify the primary and secondary objectives.Design and Outcomes Provide a very brief description of the study design （e.g., multicenter, randomized, double-masked, Phase III）, including the outcome variables for the primary and, if applicable, secondary objectives.U

10、se brief overview diagram here, if applicable. Complex diagrams may be included in Section 3, Study Design, instead.Interventions and DurationBriefly describe the interventions to be compared. Indicate the total length of time each subject will be on study （intervention period + additional followup

11、off intervention, as applicable）.A brief statement about the schedule and type of evaluations to be performed during the study may also be included.Sample Size and PopulationBriefly describe the number and type （patient population） of subjects to be studied.If the randomization will be stratified, l

12、ist the stratification factors. If there will be separate objectives and outcome variables for the strata, list these in the appropriate sections （above）.1 STUDY OBJECTIVESPrimary ObjectiveThe primary objective should always be to address a specific hypothesis. State the hypothesis in quantifiable t

13、erms; e.g., “the experimental treatment will result in 12 months of additional survival compared to the control treatment.” For statistical purposes, it may be worthwhile to state both the null and the alternative hypotheses. This primary objective must match the one used in section 9, Statistical D

14、esign.Secondary ObjectivesSecondary objectives may or may not be hypothesis-driven, may include secondary outcomes, and may include more general non-experimental objectives （e.g., to develop a registry, to collect natural history data）.2 BackgroundRationaleDescribe the patient population to be studi

15、ed and justify any restrictions on the population. Name and describe the intervention regimens, and justify why these particular interventions have been chosen. Describe and justify the route of administration, dosage regimen, intervention period, etc. Spell out the need, relevance and priority for

16、the study. Supporting DataProvide the scientific and medical data （e.g., results of Phase I and II studies） that justifies the study, its design, and the intervention groups. Summarize the known and potential risks of the interventions. For drug studies, package insert information can be referred to

17、, but does not need to be included unless there is a new, significant change. Justify any aspects of the study not FDA-approved （e.g., different dosing schedule, new combination of drugs, new drug formulation）.3 STUDY DESIGNBriefly describe the study design and indicate, in general terms, how the de

18、sign will fulfill the intent of the study. Use diagrams to explain design complexities.4 SELECTION AND ENROLLMENT OF SUBJECTSInclusion Criteria4.1.1 The disease or disorder under study, and how it is to be documented, i.e., diagnostic methods, criteria for classification, etc.4.1.2 Clinical indicato

19、rs of current status, as measured within XX days of randomization.4.1.3 Prior therapy, if any. Consider listing specific prior treatments. Consider listing the allowable duration of prior therapy for the specific population to be studied （e.g., treatment-nave, treatment-experienced, or prior-treatme

20、nt-failed “salvage” subjects）. 4.1.4 Demographic characteristics （e.g., gender, age） as applicableExclusion Criteria4.1.5 List specific clinical contraindications. Specify grades of signs/symptoms.4.1.6 Clinica/laboratoryl indicators of current status, obtained within XX days prior to randomization.

21、 List the specific tests to be performed and the narrowest acceptable range of laboratory values for exclusion, consistent with safety. 4.1.7 Specify any exclusion related to pregnancy, lactation, or plans to become pregnant. Specify methods for assessing current status and willingness to use contra

22、ception, if applicable.4.1.8 Use of excluded drugs, devices, etc. within XX days prior to study entry.4.1.9 For drug studies: Allergy/sensitivity to study drugs or their formulations.4.1.10 Specify any clinical （e.g., life expectancy, co-existing disease）, demographic （e.g., age） or other characteri

23、stic that precludes appropriate diagnosis, treatment or follow-up in the trial. 4.1.11 Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.4.1.12 Serious illness （requiring systemic treatment and/or hospitalizat

24、ion） until subject either completes therapy or is clinically stable on therapy, in the opinion of the site investigator, for at least XX days prior to study entry. List specific illnesses and acceptable time.4.1.13 Inability or unwillingness of subject or legal guardian/representative to give writte

25、n informed consent.Study Enrollment Procedures4.1.14 Describe the method for identifying and recruiting candidates for the trial.4.1.15 Describe procedures for documentation of reasons for ineligibility and for nonparticipation of eligible subjects.4.1.16 Describe consent （and assent） procedures. 4.

26、1.17 Describe the procedure for obtaining intervention group assignment.5 STUDY INTERVENTIONSInterventions, Administration, and DurationIndicate each study intervention, including how it is administered and the schedule, as well as potential side effects. Indicate where the subject will be treated （e.g., intensive care unit）. State guidelines for use of appropriate supportive care medications or treatments.Handling of Study InterventionsDescribe how the interventions are to be acquired by the participating clinical sites （e.g., the pharmaceutical company will distribute