Research Organization Document 

Phase II  
The next section of your research organization document contains the specifics to
your research design. Please use a different color ink to answer the questions below.
Remember to answer these questions in the discussion forum for feedback from the
instructors. You will turn in Phase I and Phase II of the Research Organization Document at
the end of this module. Please note that you cannot move forward with your data collection
until after your topic is approved. 
Basic Study Components 
1. What research design are you pursuing? 
An experimental research approach will be used.  
2. Do any group members need to obtain IRB approval? [To determine if you need IRB
approval from your clinical site to conduct research, ask your clinical preceptor. **Note:
If you need to obtain IRB approval, you CANNOT use that site for DATA COLLECTION
due to issues in past years. The student at that site should have a different role in the
project (writer or data analysis)]. List each student in the group. 
 
No, no students will need IRB approval.  Haley will be collecting all data, however it will
all be anonymized through excel spreadsheets.  Brianna- Data Analysis, David- Writer
 
3. Will your study be prospective or retrospective? 
 
This study will be a retrospective study. 
 
4. Number of research samples (ex: patients or survey participants) for data collection 
 
We will have a samples size of 10 head and neck cancer patients.  
Data Collection Details 
1. How many clinical sites will you be collecting data from? 
We will be collecting data from 1 clinical site: Mayo Clinic, Rochester. 
2. What information are you interested in (if a planning study, list structures for
evaluation; if a study survey, list your study questions)? 
We are interested in pursuing a quantitative study evaluating collimator angles of 0
degrees and 90 degrees. We are interested in the ability of these angles to reduce the laryngeal
dose while still achieving PTV coverage of at least 95% of the prescribed dose in VMAT plans
for head and neck cancer patients.

3. What are your inclusion criteria? Exclusion criteria? 

Our inclusion criteria consist of 2 dose-volumes, bilateral neck nodes, Squamous Cell
Carcinoma (SCC), stage 2-4c, Simultaneous Integrated Boost (SIB) technique,
primary radiation and PTV lengths of 24cm or less. 
Our exclusion criteria consist of sequential boosts, pre-treatment surgery
or, previous radiation treatments
 4. How will you limit the number of variables in your study? (For example, if you are
doing a planning study, only 1 person should be doing the planning to eliminate the
variables.) 
In order to limit the number of variables in our study, only 1 person will be collecting data from
1 clinical institution. Planning objectives will be kept the same between all plans. All
optimization objectives will be kept the same between plans. Collimator angles are the only
thing that will change between optimizations.
5. How will you anonymize your patients? (It is often necessary to transfer data sets or
patient information between group members. It is VERY IMPORTANT that you respect
HIPPA protocols! If you need to transfer data sets between facilities, we can assist you
through ProKnow. If you simply need to transfer data using a spreadsheet, you must
anonymize the patient information. It is up to you to decide how to do this). 
The patients will be anonymized through spreadsheets. Information from the plans
will be entered into spreadsheets without patient specific identifiers.  
 
6. How will you record your data for evaluation? (All anonymized data should be
housed in OneDrive. The data collector may keep a spreadsheet of the anonymized
datasets in the clinic if needed. This should not be shared with anyone outside of the
clinic) 
The anonymized data will be saved to an Excel document on OneDrive for others to
evaluate. Excel document is already on OneDrive.
 
7. What resources (in addition to the literature search) are available for you to use? 
The other resources available, besides the literature research, are the clinical
preceptors, dosimetrists, physicists and physicians at each of our clinical sites.  
 
8. Previous research study that will be used for data analysis (ex: RTOG study
constraints): 
The research study that will be used for data analysis is RTOG 1016 PHASE III TRIAL
OF RADIOTHERAPY PLUS CETUXIMAB VERSUS CHEMORADIOTHERAPY IN HPV-
ASSOCIATED OROPHARYNX CANCER. 
https://clinicaltrials.gov/ProvidedDocs/34/NCT01302834/Prot_SAP_001.pdf  
Group Roles 
Roles of each group member (members may have multiple roles) 
Group Leader-someone who will keep the group on track, make sure group
members are adhering to deadlines, be the direct point of contact for the
instructor with overall questions, update the research organization
document throughout the course of research) Bri
Data Collector(s)-someone who will be doing the data collection and data
reporting in excel; maintaining journal entries) 
Haley 
Data analysis-someone who will be responsible for analyzing the raw data,
running any statistical tests and providing conclusive data for the writer 
Bri 
 Writer-someone who is responsible for writing the outline (later in the
course) and the paper; usually the best writer of the group takes this role   
David 
**Only 1 group member can write the paper so that the tone of paper is
consistent. 
Editor This should be ALL group members except the writer 
***The highlighted roles are the roles that require the most work and should be split
between all 3 group members. If you have a group of 2, the work must be divided
equally.  
Project Template 
What project template will you be following? (review the quantitative or qualitative
lecture). 
 
Our group will be following the research paper template in the quantitative lecture.