Clinical Trial Protocol Template

[Insert full study title]

[Insert short study title]

[Insert protocol version number and date]

Clinical Trial Protocol and Protocol Amendment

General Information

Protocol title

[Insert protocol version number and date]

Clinical trial protocol and protocol amendment

Protocol number Version number Version date

[Insert protocol version number and date]

General Information

Trial sponsorPlease indicate the name of the trial sponsor. Please note that from a TGA perspective, the sponsor of a clinical trial is that individual who endorses the CTN or CTX form. A sponsor must be an “Australian Entity” for the purposes of the CTN or CTX.NameAddressContact

Trial sponsor authorisationName and title of the person(s) authorized to sign the protocol and the protocol amendment(s) for the sponsor. Title Name Email

Trial SitesSite name Site address

Chief InvestigatorPlease include the name and title of the investigator who is responsible for conducting the research including address and telephone number(s). The Chief Investigator (CI) should not be a student as the CI is responsible for the overall ethical conduct of the studyTitle Name Email Address and telephone number

Study Investigators Please include the name and title of the investigator(s) who is (are) responsible for conducting the research including address and telephone number(s). Title Name Email Trial Site

Independent and/or trial safety committeesPlease include the name and title of the identified person(s) or committee with suitable expertise to assist and advise the HREC about reports of serious adverse eventsTitle Name Email

Funding and resourcesPlease explain how the study is being funded. (eg Commercial sponsor, Department funds etc)

InsurancePlease detail the insurance requirements that will be put in place for the trial.

[Insert protocol version number and date]

Introduction and Background Information

Background informationInclude information based on literature review and investigators’ experiences, brief history of the disease including prognostic factors. All references must be listed at the back of the protocol. The information provided at this section must provide references to literature and data that are relevant to the methods, products, and the population being used in this trial.

Trial rationaleThe rationale specifies the reasons for conducting the research in light of current knowledge. It should include a well-documented statement of the need/problem that is the basis of the project, the cause of this problem and its possible solutions. It is the equivalent to the introduction in a research paper and it puts the proposal in context. It should answer the question of why and what: why the research needs to be done and what will be its relevance.

Trial ObjectiveProvide a detailed description of the objective and the purpose of the trial.

Type of studyFor example a randomised control trial, qualitative study, case control study etc

Trial designIf applicable indicate the primary endpoints and the secondary endpoints to be measure during the trial. In addition provide an explanation of the design type (e.g. (e.g. double-blind, placebo-controlled, parallel design) and a schematic diagram of trial design, procedures and stages.

Trial populationProvide a description of the population to be studied in this trial and explain why this population is essential to meeting the aims of the research.

Compliance statementProvide a statement that indicates the trial will be conducted in compliance with the protocol.

[Insert protocol version number and date]

Investigational product(s)List the investigational product(s) to be used in this trial. The information provided at this section must provide the product name, its manufacturer, its intended purpose and an overview of its approval status within Australia or in other countries. Product nameIntended use(s)Manufactures nameApproval conditions Please provide an overview of the products approval status within Australia or in other

countries.Provision of product Indicate how the product will be sourced specifically for this trial.Administration of product.

Provide a description and justification of how this product will be administered.

Risks/Benefits Provide a summary of the known risks or discomforts that may be experienced during the use of this product.

Add or remove boxes for additional productsProduct nameIntended use(s)Manufactures nameApproval conditions Please provide an overview of the products approval status within Australia or in other

countries.Provision of product Indicate how the product will be sourced specifically for this trial.Administration of product.

Provide a description and justification of how this product will be administered.

Risks/Benefits Provide a summary of the known risks or discomforts that may be experienced during the use of this product.

Investigational product dispensing and packagingProvide a description of how the investigational product will be packaged labeled and then dispensed.

Investigational product administration Provide a description of the dosage or application regimen of the investigational product(s).

Trial DurationIndicate the expected duration of subject participation, and a description of the sequence and duration of all trial periods, including follow-up, if any.

[Insert protocol version number and date]

Trial Documentation

Documentations Version # Version date Appendix #Invitation emailStudy advertisementParticipant information sheet and consent formScreening data collection toolData collection toolSafety monitoring report formCertificate of insuranceClinical Trial Notification receiptANZCTR registration receiptCVs of all study investigators

[Insert protocol version number and date]

Selection and Withdrawal

Recruitment Explain how potential participants will be identified for the study and where. For record review, explain how records will be identified. Examples include the following:

review of databases (please identify the database and the custodian) review of outpatient clinic files, Emergency Department admissions, inpatients (please include who

will be reviewing the notes e.g. research coordinator) advertisements (include where the advertisement will be e.g. newspaper, poster in outpatients area or

hospital foyer, radio announcements) Information Letter to Medical practitioners Explain how potential participants will be screened for the study.

Eligibility CriteriaDetail the inclusion and exclusion criteria that will be used to determine whether a person can be include in the research.

ScreeningDescribe the process that will be followed in order to screen participants to ensure that they meet the inclusion criteria.

Withdrawal of study participantsIndicate the criteria that will be used to withdraw study participants from the study (i.e. terminating investigational product treatment/trial treatment) and procedures specifying:

a) When and how to withdraw subjects from the trial/ investigational product treatment. b) The type and timing of the data to be collected for withdrawn subjects.c) Whether and how subjects are to be replaced. d) The follow-up for subjects withdrawn from investigational product treatment/trial treatment.

[Insert protocol version number and date]

Study treatments and proceduresProvide a description of the individual be administered, including the name(s) of all the product(s), the mode(s) of administration, and the treatment period(s), including the follow-up period(s)for subjects for each investigational product treatment/trial treatment group/arm of the trial.

Study Flow ChartDiagram of the study design (example below)

Enrolment

Randomisation

Treatment Phase

(e.g. 12 weeks)

Group A Group B

Include all study visits and all study procedures conducted at each visit. This information can also be displayed in a table. Example below

List Interventions

Enrolment Visit Visit 1 Visit 2 Visit 3 Final Study Visit

Informed Consent

Inclusion / Exclusion critieria

Physical examination

CXR

Adverse Event & Serious

Adverse Event Assessment

[Insert protocol version number and date]

ContraindicationsIndicate the list of medication(s)/treatment(s) permitted (including rescue medication) and not permitted before and/or during the trial.

Subject complianceExplain the procedures that will be followed by the research team in order to ensure that the trial participants complete the treatment(s) as set out in the protocol.

Safety Monitoring and Reporting

Adverse Event (AE) Any untoward medical occurrence in a patient or clinical trial participant administered a medicinal product and that does not necessarily have a causal relationship with this treatment.

Reporting

A record of all adverse event reports will be recorded by the research team.

Adverse Reaction (AR) Any untoward and unintended response to an investigational medicinal product related to any dose administered.

Reporting

A record of all adverse event reports will be recorded by the research team.

Serious Adverse Event (SAE)/Serious Adverse Reaction (SAR)

Any adverse event/adverse reaction that results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, or is a congenital anomaly or birth defect.

Reporting

Any serious adverse events will be reported via email to humanethics@unsw.edu.au using the UNSW safety monitoring report form

Significant Safety Issue (SSI)

A safety issue that could adversely affect the safety of participants or materially impact on the continued ethical acceptability or conduct of the trial.

Reporting

Urgent safety measure Reports defined as an urgent safety measure that

adversely affect the safety of participants or materially impact on the continued ethical acceptability or conduct of the trial will be reported via email to humanethics@unsw.edu.au using the UNSW safety monitoring report form within 72 hours.

Reports defined as significant safety issues should be notified via email to humanethics@unsw.edu.au using the UNSW safety monitoring report form within 15 calendar days of the research team becoming aware of the issue.

Suspected Unexpected Serious Adverse Reaction (SUSAR)

Definition: An adverse reaction that is both serious and unexpected.

Reporting All suspected unexpected serious adverse reactions

occurring in Australian participants will be reported to the Therapeutic Goods Administration and the HREC within 15 calendar days of becoming aware of the case.

All fatal or life threatening Australian suspected unexpected serious adverse reactions will be reported to the Therapeutic Goods Administration and the HREC via email to humanethics@unsw.edu.au using the UNSW safety

[Insert protocol version number and date]

monitoring report form immediately, but no later than 7 calendar days after being made aware of the case, with any follow-up information within a further 8 calendar days .

StatisticsThe information provided at this section needs to include the following: A description of the statistical methods to be employed, including timing of any planned interim analysis

(ses). The number of subjects planned to be enrolled. In multicentre trials, the numbers of enrolled subjects

projected for each trial site should be specified. Reason for choice of sample size, including reflections on (or calculations of) the power of the trial and

clinical justification. The level of significance to be used. Criteria for the termination of the trial.

EthicsHuman research ethics approval will be sought before the commencement of the project.

HREC Name Ethics Reference Ethics approval date

Ethics expiration date

[Insert protocol version number and date]