INVESTIGATOR STUDY PLAN - REQUIRED
INSTRUCTIONS:

Provide information once. It’s better to refer to earlier items (e.g., “See #...”) than to
repeat.

If an item does not apply, type “NA.”
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If the information is available in a sponsor protocol, grant, investigator brochure, or
proposal – for any item marked with an asterisk (*) – simply reference the title and
page numbers of that reference document and upload a copy of the document to
eIRB.
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Delete instructions as you answer each item.
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Use a version number or date in the file name. When you upload the document to
eIRB, leave the title field blank so that eIRB uses the file name to label the
document.
1. TITLE
Include the full title as listed in eIRB.
2. EXTERNAL IRB REVIEW HISTORY*
N/A (likely—if not, see ISP template for instructions)
3. PRIOR APPROVALS:
N/A (likely—if not, see ISP template for instructions)
4. OBJECTIVES*
Describe the purpose, specific aims, or objectives. State the hypotheses to be tested.
5. BACKGROUND*
Describe the relevant prior experience and gaps in current knowledge. Describe any relevant
preliminary data. Provide the scientific or scholarly background for, rationale for, and
significance of the research based on the existing literature and explain how the research will
add to existing knowledge.
6. INCLUSION AND EXCLUSION CRITERIA*
Describe the criteria that define who will be included or excluded. If there are sub-groups, label
and describe each one. Indicate specifically whether you will include or exclude each of the
populations listed below. You may not include these populations in your research unless you
include them in your inclusion criteria:
 Adults lacking capacity
 Individuals who are not yet adults (infants, children, teenagers)
 Pregnant women
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Prisoners
Inclusion Criteria:
Exclusion Criteria:
7. STUDY-WIDE NUMBER OF SUBJECTS*
N/A (likely—if not, see ISP template for instructions)
8. STUDY-WIDE RECRUITMENT METHODS*
N/A (likely—if not, see ISP template for instructions)
9. STUDY TIMELINES*
Describe:
 The estimated date for the investigators to complete this study (complete primary
analyses)
10. STUDY ENDPOINTS*
Describe:
 Describe the primary and secondary outcome measures
11. PROCEDURES INVOLVED*
For medical record review, walk step-by-step through the process of identifying records,
accessing data, and recording data. How and where will you search for records? What
information, if any, will you download? What information will you record to a data collection
sheet? Provide the date range of the charts to be reviewed (e.g., mm/dd/yyyy to mm/dd/yyyy).
The data collection procedures for the retrospective chart review will be as follows:
1) A data collection sheet will be created with data recorded such that subjects cannot be readily
identified from looking at the recorded data.
2) A separate identifier list will be created with the medical record numbers of the subject pool.
This is only a list of identifiers. No other information.
3) The existing records for one, some, or all subjects will be accessed.
4) A random medical record number will be selected, the record reviewed, and the information
recorded on the data sheet. All the verification will be done at this time and then marked on the
identifier list that the subject is done.
5) Step (4) will be repeated for all subjects.
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In the end, there will be a list of medical record numbers, a separate list of data, and no link
between the identifiers and the data.
The list of identifiers will be destroyed, upon/once/after...(indicate when the list of identifiers
will be destroyed. HIPAA regulations for research specify that this should occur at the earliest
opportunity possible)
12. DATA AND SPECIMEN BANKING*
N/A
13. Data Analysis and Management*
 Provide a power analysis and/or support for the sample size proposed for this study.
 Describe the data analysis plan, including any statistical procedures.
 Describe any procedures that will be used for quality control of collected data.
14. PROVISIONS TO MONITOR THE DATA TO ENSURE THE SAFETY OF SUBJECTS*
N/A—This is a retrospective chart review in which subjects have already received the standard
of care for their condition. There are no interventions or interactions with subjects for the
purposes of the research.
15. WITHDRAWAL OF SUBJECTS WITHOUT THEIR CONSENT*
N/A
16. RISKS TO SUBJECTS*
The potential risk of being in this study is that subjects’ personal information could be lost or
exposed. This is very unlikely to happen, as the data is being recorded in an anonymized fashion.
17. POTENTIAL DIRECT BENEFITS TO SUBJECTS*
N/A
18. VULNERABLE POPULATIONS*
N/A—This is a retrospective chart review. Please see #6 Inclusion and Exclusion Criteria.
19. MULTI-SITE RESEARCH*
N/A (likely—if not, see ISP template for instructions)
20. COMMUNITY-BASED PARTICIPATORY RESEARCH*
N/A (likely—if not, see ISP template for instructions)
21. SHARING OF RESEARCH RESULTS WITH SUBJECTS*
Research results will not be shared with subjects or subjects’ providers. (likely—if not, see ISP
template for instructions)
22. SETTING
Describe the sites or locations where your research team will identify and enroll potential
subjects, perform research procedures, and conduct data entry and analysis. Describe any
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necessary facilities (e.g., access to private offices). If you are conducting research outside of
UMass-Worcester, describe any site-specific regulations or customs affecting the research and
any local scientific and ethical review.
23. RESOURCES AVAILABLE
Describe study personnel.
 Do not list people by name. Provided new personnel meet a description in the approved
study plan, the PI can add study staff by updating the Project Personnel tab in eIRB (or
using the Non-UMass Personnel List, if appropriate) instead of obtaining prior IRB
review and approval for a Modification to the study plan.
 List each study staff role (e.g., PI, co-investigator, research assistant, research
coordinator). Be sure the roles match the roles on the Project Personnel tab in eIRB.
 Describe the responsibilities for each role.
 Describe the qualifications required to serve in each role (e.g., training, including
training by the PI; experience; oversight). When applicable, describe knowledge of the
local study sites, culture, and society.
 Describe the time the PI and staff will devote to conducting and completing the research.
 If the PI is a student, resident, fellow, or other trainee, confirm a faculty advisor has been
appointed to oversee the conduct of the research.
Describe your process to ensure that all persons assisting with the research are adequately
informed about the protocol, the research procedures, and their duties and functions.
24. LOCAL RECRUITMENT METHODS
Indicate how subjects will be identified, as well as how their records will be accessed (e.g. their
records will be accessed from their electronic medical record, under a HIPAA waiver).
Justify the feasibility of recruiting the required number of suitable subjects within the given
recruitment period. For example, how many potential subjects do you have access to? What
percentage of them do you need to identify/enroll?
25. LOCAL NUMBER OF SUBJECTS
Indicate the total number of subjects to be accrued locally.
26. CONFIDENTIALITY
Describe the data:
 What types of data will exist (e.g. anonymized data)? Will they be in hard copy or
electronic format? You may wish to refer to the data collection sheet(s) uploaded to the
submission.
Describe the steps that will be taken to secure data during data collection, storage, use, and
transmission (you may wish to refer to section #11 Procedures Involved to address certain
questions below). For example:
 Which staff roles will be responsible for their receipt or transmission?
 How will they be collected and transported?
 Where and how will they be stored?
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How long will they be stored?
Will any portable devices (e.g., laptops, thumb drives) be used?
Which staff roles will have access?
How will you limit access?
Will staff undergo any special training or require special authorizations?
Will you implement electronic controls, such as password protection? Encryption?
Will you use physical controls, such as locked offices?
When and how will you securely destroy identifiers?
When and how will you securely destroy the data in full?
27. PROVISIONS TO PROTECT THE PRIVACY INTERESTS OF SUBJECTS
As this is a retrospective chart review, a HIPAA waiver has been requested (please see the
HIPAA waiver uploaded with the submission). Subjects’ Protected Health Information (PHI)
will be recorded anonymously, and will not be directly linked to Personally Identifiable
Information (PII). Please see section #11 Procedures Involved for more details.
28. COMPENSATION FOR RESEARCH-RELATED INJURY
No funds have been set aside, as this is a minimal risk, retrospective chart review.
29. ECONOMIC BURDEN TO SUBJECTS
As the research involves retrospective chart review only, there will be no costs for which
subjects may be responsible for due of participation in the research.
30. CONSENT PROCESS
The study meets the regulatory criteria for a waiver of consent (45 CFR §46.116(d)), for the
following reasons:
a. The research involves no more than Minimal Risk to the subjects: This is a
retrospective chart review in which all data is recorded anonymously, significantly
minimizing the risk of breach of confidentiality. Furthermore, there are no subject
interactions and/or interventions for the purposes of the research.
b. The waiver or alteration will NOT adversely affect the rights and welfare of the
subjects: As mentioned above, the data will be recorded in an anonymous fashion.
Additionally, all subjects will have received the clinical standard of care for their
condition. Participation in the research will not have a direct impact on the care that they
have received, or will receive in the future.
c. The research could NOT practicably be carried out without the waiver or
alteration: The research could not practicably be carried out without the waiver or
alteration due to the large number of subjects that are intended to be included in the data
set. In addition, subjects may have died, or may have moved without providing updated
contact information. Lastly, selection bias may skew the data should consent be required
from each subject.
d. In the event it becomes appropriate to provide subjects with additional pertinent
information after participation, we will seek the guidance of the IRB.
e. The research is not FDA-regulated. (must be true)
f. The research does not involve non-viable neonates as subjects. (must be true)
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31. PROCESS TO DOCUMENT CONSENT IN WRITING
N/A
32. DRUGS OR DEVICES
N/A
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