Research Administrative Pre-Authorization (RAP)
PROPOSAL TEMPLATE FORM
RAP review is required for all research conducted at Aurora. You will receive an email describing the
outcome of this review; a favorable pre-authorization is required before you can continue with the project
approval, for example: submission to the IRB/IACUC, medical record release, etc.
This form is not expected to be an in-depth, complete protocol. However, it is important that you provide
enough details so that the reviewer can accurately assess the rationale, processes and outcomes in order to
make the determination as to whether the proposal is meritorious and in alignment with the priorities and
mission of Aurora Health Care and the Aurora Research Institute (ARI).
Pages 3-4 of this form provide details and examples to reference when completing this form. Use the
complete guide or the icons though out this form to link to the relevant section.
This form should be completed by the Program Director/Principal Investigator (PD/PI)/ Research
Regulatory Specialist
Submit completed form to research.preauthorization@aurora.org
If you need help in completing this proposal,
please contact ARI staff research.preauthorization@aurora.org or 414-219-7886
CONTACT INFORMATION
PD/PI name:
Aurora Employee?(yes or no)
Co-I name(s) (if applicable):
Aurora Employee?(yes or no)
Address/location:
Department:
Email:
Phone:
Regulatory Specialist name (if applicable):
Email:
Will any data leave Aurora?
Yes
Non-Aurora collaborators: Name:
No
Explain:
Institution:
Explain:
IIR RAP proposal template v.2.3 3Nov2015
Page 1 of 5
GENERAL INFORMATION
Date of submission:
Category of research (highlight all that that apply)
- Industry funded clinical trial
-
- Investigator Initiated human subject research
- Cardiology Fellows (as study lead)
* PI cannot submit RAP request directly. Send
request to Sara.Walczak@aurora.org for pre-review
- Animal research
- Basic science research
- other
Use of a DRUG, DEVICE, or BIOLOGIC (FDA requirements/considerations)
Does this proposal involve the use of a DRUG, DEVICE, or BIOLOGIC (other than those already
approved for use in the indicated population) in research subjects? If yes, provide a brief explanation.
Drug: Yes
Device: Yes
No
No
Biologic: Yes
No
Combination product: Yes
No
Brief Explanation:
Are you a nurse? Yes
No
Are you a fellow, resident, or other student? Describe:
IIR RAP proposal template v.2.3 3Nov2015
Page 2 of 5
STUDY DETAILS
Study title
Background and literature
Study Rationale/Merit
Hypothesis/aims/objectives
Study design and methods
Population/samples size
Subject recruitment/informed consent
Consideration of Risks and Benefits
Data analysis and review
Resource availability and timeline
Outcomes
Key References
IIR RAP proposal template v.2.3 3Nov2015
Page 3 of 5
GUIDELINES For Completing Research Administrative Pre-Authorization (RAP)
Proposal Form
FDA considerations/ requirements back to form
Include a description of the use of drugs, medical devices or biologics used in the research.
It is important to address any FDA considerations or requirements if the study:
- involves the use of a DRUG or a BIOLOGIC in a human other than the use of an approved drug in the
course of medical practice.
- evaluates the safety or effectiveness of a DEVICE in research subjects, a control group or their
biological specimens.
- involves a Humanitarian Use Device (“HUD”) in a research study.
If you answered “Yes” to any of the questions above, please note that the IND/IDE committee will review the
protocol prior to scientific review and an FDA application may be required.
Study title back to form
Make your title specific and detailed. If your application is a revision, do NOT change the title.
Background and literature back to form
Include the background and history for this topic.
Study Rationale/Merit back to form
State the problem and provide justification and rationale for the 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).
Relate this to the longer-term, big picture scientific objectives and how this study will impact the subject,
this patient population and/or society, including a description of the public health impact.
Hypothesis/aims/objectives back to form
Describe the overall objectives including primary and any secondary objectives (objectives should be
specific and well defined).
Outline the research question(s) and hypothesis(ses) to be tested by the study.
Study design and methods back to form
Describe the type of research, for example chart review (retrospective or prospective) or randomized,
placebo controlled, phase I, II or III.
Identify the sites involved, if applicable.
Give an overview of all study-related procedures and treatments during study visits. Be sure to create a
clear differentiation between research procedures and standard care.
Outline the process for specimen/data collection.
Things to consider for specimen/data banking studies:
 What types of specimens/data will be collected?
 Where will the specimens/data be housed and who will be responsible for oversight of the bank
(including future use)?
 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?
IIR RAP proposal template v.2.3 3Nov2015
Page 4 of 5
Things to consider 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?
 Who will have access to this collected information?
 Are there any plans for coding or de-identifying the information that is collected? How long will
the information be kept and what are the plans for destroying it once the study is completed?
 Create a list of variables that will be abstracted from the medical record ("data collection tool").
Population/samples size back to form
Describe the study population, including subject characteristics and general inclusion/exclusion criteria.
Provide details of sample size.
Subject recruitment/informed consent back to form
Provide some a general idea about the methods proposed for screening and enrolling subjects.
Outline procedures for obtaining informed consent (if not waived).
Consideration of Risks and Benefits back to form
Summarize any anticipated risks including safety, financial or conflict of interest.
Address whether or not the study is of benefit the subjects as well to Aurora, Aurora patients and the
community.
Please note that if your submission requires IRB review, the IRB will require a detailed discussion of risks
and benefits. Depending on the study, they may also require a data and safety monitoring plan.
Data analysis and review back to form
Describe how the data will be used to answer your research question.
Provide an overview of the statistical analyses will you use and how will you interpret the results.
If you need help from biostatisticians, please contact the IIR Research Regulatory Specialist at 414-2197886 or research.preauthorization@aurora.org
Resource availability and timeline back to form
Address your timeframe, including expected start date and completion date and whether this study can
be done effectively within that time (including data analysis and abstract/manuscript preparation).
Indicate if you have the necessary equipment, space, support staff and other facilities to conduct the
research. If you need additional resources for the completion of this project, please provide details.
Provide details of funding source if available. If you have existing funding for your study, please submit
the related budget and budget justification.
If you need assistance with identification of funding source or a grant application, please contact the
Sponsored Programs Office at 414-219-7803 or SPO@aurora.org
Outcomes back to form
Identify the overall anticipated outcome.
Describe how successful completion of the proposal produce a patient-centered outcome in one or
multiple dimensions (individual patient, social, system, specific application and the medical/healthcare
field)
Identify where you plan to present the results (national meeting, publication, etc.)
IIR RAP proposal template v.2.3 3Nov2015
Page 5 of 5