Note: This document is intended to guide investigators in preparing a minimal risk research trial protocol for submission and review. This protocol template may be used for the following studies: specimen/data collection; banking/future research; retrospective chart reviews with identifiable data collection; prospective questionnaire research. This list is not exhaustive, call the RSPP office (414.219.7744) if you have questions on what constitutes minimal risk research.

Aurora Healthcare, Inc.

Protocol Title:[Title]

Principal Investigator:[First Name] [Last Name] [Title]

[Position]

[Address]

[Phone:]

[Fax:]

[Email:]

Investigators

and Key Personnel:[First Name] [Last Name] [Title]

[First Name] [Last Name] [Title]

[First Name] [Last Name] [Title]

[First Name] [Last Name] [Title]

[First Name] [Last Name] [Title]

  1. Background and Rationale
  • Background and history
  • State the problem and provide justification and rationale for proposed research – Rationale should be placed within the context of existing literature or within your own observation (medical need, clinical relevance, advantage of suggested approach over current best medical practice)
  • Public health impact – How will this study impact the subject, this patient population, and/or society
  1. Objectives and Specific Aim
  • Describe the overall objectives
  • Primary and any secondary objectives (objectives should be specific and well defined)
  • Hypothesis(ses) to be tested by the study
  1. Study Design & Methodology

The study design should describe an adequate plan for answering the hypotheses listed above (retrospective/prospective, randomization, comparison groups, pre/post testing etc).. This should include an in-depth explanation of all study related activities to be performed including the time of the activity in a logical and sequential format. Also include the study duration and sample size and criteria for sample size determination. Procedures being done solely for research purposes should be clearly identified.

  1. Eligibility
  • Identify the patient population to be evaluated in the research trial
  • Describe the source of the subjects (indicate whether patients/records from other practices are being accessed)
  • Detailed list of inclusion criteria
  • Detailed list of exclusion criteria
  1. Subject Enrollment

Describe the methods of enrollmentand outline procedures for obtaining informed consent (if not waived)

  • Include the following, if applicable:
  • Where will recruitment occur?
  • Where and when will consent be obtained?
  • Who will obtain consent?
  • What is the advertising plan, if applicable? Is payment being offered for subjects?
  • What recruitment materials will be provided to the potential participant, if applicable?
  • What procedures will be used for screening?
  • What happens with screen failures (including data gathered during screening)?
  1. Specimen/Data Collection and Procedures

Outline the process for specimen/data collection.

  • For specimen/data banking studies:
  • What types of specimen/data will be collected?
  • Where will the specimens/data be housed and who will be responsible for oversight of the bank?
  • How long will specimens/data be kept? How are the specimens going to be used?
  • How will the specimens/data be destroyed upon study completion?
  • If specimens/data will be banked for future use, what will be the process for providing investigators with access to the bank and how will this be tracked?
  • For record review studies:
  • What is the source of the medical information?
  • Does the medical record information to be used in the study already exist?
  • Will some or all of the medical record information to be used be from data sources created in the future (e.g., after the date of IRB approval)?
  • What is the time period of the medical information under review?
  • Who will have access to this collected information?
  • Are there any plans for coding or de-identifying the information that is collected? If yes, what are the plans?
  • How long will the information be kept and what are the plans for destroying it once the study is completed?
  • Create list of variables that will be abstracted from the medical record chart ("data collection tool")
  1. Risks, Protection & Benefits
  • Identify and list any foreseeable risks for subjects. Although a minimal risk study may not present physical risks to subjects, there are risks to confidentiality when identifiable data is collected.
  • Describe in detail the plan in place to minimize or protect subjects from the foreseeable risks.
  • Describe any risks that may be associated to breach of confidentiality and include a plan in place to minimize a breach of confidentiality.
  • Identify and list any benefits of this research for the subjects, a class of subjects or society as a whole. If no benefits are expected for the individual subject/participant, this should be stated.
  1. Data Analysis and Review

Describe how samples will be analyzed and the procedures/calculations/tests that will be used. Describe who will have access to identifiable information.

  1. Statistical Considerations

The statistical section should clearly outline how the data will be evaluated in relation to each of the objectives. This section should provide enough evidence to convince a reviewer that the proposed design has a reasonable chance of achieving the principal objectives of the research. Include rationale and sample size calculations for the proposed number of subjects. Summarize the statistical approach to the analysis of the study data. Include how the study endpoints will be achieved and a description of the power analysis.

  1. Outcomes

What are the anticipated outcomes of this study? How will successful completion of this project produce a patient-centered outcome?

  1. Regulatory Requirements

In this section, discuss the informed consent and the regulatory requirements below:

Research conducted at Aurora must comply with International Conference on Harmonization Good Clinical Practice (ICH GCPs). There should be an appropriate plan to obtain and document legally effective informed consent.

Before informed consent may be obtained, the investigator, or a persondesignated by the investigator, should provide the subject ample time and opportunity to inquire about details ofthe trial and to decide whether or not to participate in the trial. All questionsabout the trial should be answered to the satisfaction of the subject or the subject'slegally acceptable representative.

Prior to a subject’s participation in the trial, the written informed consentform should be signed and personally dated by the subject, and by the person who conducted the informedconsent discussion.

If a waiver of informed consent or a waiver of the requirement for documentation ofinformed consent will be requested, address the following here:

  • Does the research involve no more than minimal risk to the subjects?
  • How will the waiver or alteration not adversely affect the rights and welfare of the subjects?
  • Why the research could not practicably be carried out without the waiver or alteration?
  • If appropriate, will the subjects be provided with additional pertinent information after participation?
  1. References

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