Multi-Institution Registry of SRS/SBRT Procedures
Conditions: Neoplasms, Arteriovenous Malformation of Central Nervous System, Trigeminal Neuralgia
Sponsor: The Radiosurgery Society

 
RSSearch® Patient Registry Protocol  
Version Date: 7/19/2022 Version 1.1 
 
RSSearch® Patient Registry Protocol 
 
 
Sponsor:  the Radiosurgery Society® 
 
July 19, 2022 
 
 
 
 
 
 
 

 
RSSearch® Patient Registry Protocol  
Version Date: 7/19/2022 Version 1.1 
 
 
 
 
 
 
Table of Contents 
 
 
1 
Registry Title ...................................................................................................... 3 
2 
Purpose ............................................................................................................. 3 
3 
Objectives .......................................................................................................... 3 
4 
Duration ............................................................................................................. 4 
5 
Participants ........................................................................................................ 4 
6 
Sponsorship ....................................................................................................... 4 
7 
Patients .............................................................................................................. 5 
8 
Forms ................................................................................................................. 6 
9 
Data Recording .................................................................................................. 8 
10 
Patient Confidentiality ........................................................................................ 8 
11 
Security .............................................................................................................. 9 
12 
Reporting ........................................................................................................... 9 
13 
IRB/Ethics Review Committee Approval ............................................................ 9 
14 
Risks/Benefits .................................................................................................... 9 
15 
Reporting of Adverse Events ........................................................................... 10 
16 
Appendix A: Institutional Review Board (IRB) and Ethics Review Committee 
Considerations ................................................................................................. 11 
17 
Appendix B: Sample Text for Patient Consent Form........................................ 12 
18 
Appendix C: Sample Registry Authorization form ............................................ 14 
19 
Appendix D: Access to Data and Aggregate Reporting ................................... 17 
20      Appendix E: Health-Related Quality of Life Questionnaires ............................. 21 
 
 
 
 
 
 
 
 
 
 
 

 
RSSearch® Patient Registry Protocol  
Version Date: 7/19/2022 Version 1.1 
 
RSSearch® Patient Registry Protocol 
 
1 
Registry Title 
RSSearch® Patient Registry 
The RSSearch® Patient Registry is an international, multi-center ongoing database designed to track 
utilization of all available stereotactic radiosurgery (SRS)/stereotactic body radiation therapy (SBRT) and 
Spatially Fractionated Radiation Therapy (SFRT – like GRID and LATTICE radiation) systems, treatment 
practices and outcomes to help determine, over time, the most effective use of the these systems in 
management of patients with life threatening tumors and other diseases. 
 
The RSSearch® Patient Registry meets all Health Information Portability and Accountability Act (HIPAA) 
requirements regarding patient privacy and transmission of protected patient information. 
 
Participant access to data entered into the RSSearch® Patient Registry will be limited as follows: 
▪ 
Each clinical site will have full access to all data entered by that clinical site 
▪ 
Each clinical site may have access to some reports using aggregate data, if created by the Radiosurgery 
Society® (RSS).  Each clinical site may petition for access to aggregate data via the process outlined in 
Appendix D: Access to Data and Aggregate Reporting. 
 
Sponsor 
the Radiosurgery Society® 
Primary Contact 
Joanne Davis, PhD 
Executive Director 
 the Radiosurgery Society® 
Email: jdavis@therss.org  
Tel: +1.248-719-2998 
 
2 
Purpose 
The RSSearch® Patient Registry is a database designed to standardize the collection of data on the use of 
SRS/SBRT/SFRT systems in everyday practice.  Data to be recorded includes: 
• 
Characteristics of patients who are selected for these treatments 
• 
Treatment locations, disease diagnoses and lesion descriptions 
• 
Treatment goals 
• 
Treatment plans and delivery information 
• 
Outcomes data  
• 
Patient-reported quality of life questionnaires (if desired by the participating sites and approved 
by their Institutional Review Board (IRB)).  See Appendix E for list of available health-related 
quality of life questionnaires. 
 
The registry design including data collection forms were designed by a board of Clinical Advisors who are 
active users, including physicians, physicists, nurses and site administrators.  The RSSearch® Patient 
Registry uses widely accepted standards for disease classification, treatment side effects and results and 
validated quality of life measures. 
 
3 
Objectives 
Objectives of the RSSearch Registry include the following: 

 
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• 
Allow participants to record information about usage of the SRS/SBRT/SFRT systems in everyday 
practice, including patient characteristics and disease information, treatment plans and outcomes 
• 
Allow participants to record information useful for their own SRS/SBRT/SFRT business reporting 
including utilization 
• 
Provide participants with ready access to data for publication of their own SRS/SBRT/SFRT 
experience and as a tool for establishing collaborations with other participating sites 
• 
Facilitate quality improvement efforts for individual treatment providers 
• 
Provide participants the opportunity to collect quality of life data and other patient-reported 
outcomes 
• 
Understand the effectiveness of different treatment plans for different types of lesions, diseases 
and treatments 
• 
Provide comparative patient outcomes data to facilitate appropriate and successful use of the 
SRS/SBRT/SFRT system 
• 
Collect information that may be useful for reimbursement 
 
The RSSearch® Patient Registry is not a clinical trial or study.  It is listed on www.clinicaltrials.gov and 
described as an observational patient registry (ClinicalTrials.gov Identifier: NCT01885299). 
 
Information entered into RSSearch is already being collected as part of the medical record for patients at 
participating sites. 
 
4 
Duration 
The RSSearch® Patient Registry will be an ongoing effort.  This Registry began in 2005, as the ReCKord  
CyberKnife Registry and these CyberKnife patients remain embedded in RSSearch. 
 
5 
Participants 
All clinical sites performing SRS/SBRT/SFRT treatment procedures of any kind will be invited and 
encouraged to participate in the Registry.  Participation is voluntary, but Principal Investigators must be 
an active member of the Radiosurgery Society. There is no compensation for participation in the Registry, 
either to patients or to participating sites. 
 
All sites participating in the Registry will be required to have a signed Data Use Agreement (DUA) or similar 
agreement with the Radiosurgery Society and submit this protocol to their Institutional Review Board 
(IRB) or Ethics Committee Review; this will expand the opportunities for collaboration and publication. 
 
Sites will be required to comply with their own institution’s IRB or Ethics Committee Review practices for 
ongoing review and approval. 
 
Participating sites are responsible for sending the RSS Administrator documentation providing proof that 
they have received and/or have updated IRB or Ethics Committee Review approval. 
 
6 
Sponsorship 
RSSearch resides under the auspices of the Radiosurgery Society and is funded partially through the 
membership fees of the RSS.  An annual maintenance fee is required of all participants in RSSearch to 
cover costs for data storage, hosting fees, registry quality assurance (QA) and security checks. 
 

 
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The Radiosurgery Society® is a multidisciplinary non-profit organization aimed at advancing the science 
and clinical practice of radiosurgery. (See www.therss.org for additional information) 
 
Objectives of the Radiosurgery Society® include: 
• 
Improve results achieved in the field of Stereotactic Radiosurgery (SRS), Stereotactic Body Radiation 
Therapy (SBRT) and Spatially Fractionated Radiation Therapy (SFRT) by promoting scholarly exchange 
among the clinical users.  
• 
Share detailed clinical information pertaining to SRS,SBRT and SFRT to promote protocol development.  
• 
Encourage and enhance SRS, SBRT and SFRT techniques in the worldwide medical community and 
among healthcare providers and patients. 
 
7 
Patients 
All patients of any age who are screened for potential SRS/SBRT/SFRT treatment are eligible to be entered 
into the RSSearch Registry.  Some basic information including referral source, disease location etc., will be 
entered for any patient who is screened for SRS/SBRT/SFRT System treatment.  Additional detailed 
demographic, diagnostic, treatment plan and follow up data will be entered on patients who are selected 
for one or more of these treatments. Patients who are selected and treated with SRS/SBRT/SFRT 
approaches will have data about their health status collected over the long-term, as long as they are 
considered candidates for follow-up. 
 
There are no specific inclusion/exclusion criteria.  The RSSearch® Patient Registry does not require specific 
tests or measures.  Data that is collected in the normal course of a patient’s treatment and follow up are 
entered into RSSearch. 
 
There are no established endpoints for the RSSearch (as there are, for instance, for a Clinical Study); 
however, specific measures are recorded before and after treatment to determine outcomes of various 
SRS/SBRT/SFRT treatment approaches for different diseases. 
 
All prospective patients must sign or have signed an informed consent form prior to their data being 
entered into the RSSearch® Patient Registry. 
 
Initial entry of retrospective patient data may be considered under a Waiver of Authorization. 
A Waiver of Authorization may be applicable for the following reasons: 
 
• 
Risk to subject privacy is minimal 
o Procedure data is de-identified via the use of a unique identification number (ID) that 
will be created and known only to the participating site 
o Only four of the 18 variables considered protected health information (PHI) are 
necessary for use of RSSearch, specifically dates (admission, discharge, service dates, 
date of death), age (birthdates not collected), zip code and patient e-mail address 
(collected only if an individual site and their respective patients wish to use the 
Patient Portal feature of RSSearch, and then the email is visible only to the 
participating site).   
 
o The dates are important for understanding the data including, if and when: 
▪ 
Any adverse events occurred during and after the procedure 
▪ 
Key cancer outcomes including survival 

 
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o If participating sites are using the Patient Portal feature, the patient e-mail will allow 
the patient to securely log-in to the Patient Portal and access and complete assigned 
quality of life questionnaires. 
 
• 
Obtaining informed consent from patients who have already had a procedure and may not be 
returning for follow-up at a treating center performing the procedure may not be practical 
• 
Obtaining informed consent may also inhibit a participating site’s ability to completely 
characterize their patient population over time, practices associated with use of their 
SRS/SBRT/SFRT systems and long term outcomes 
 
Retrospective data is marked as such in the database and can be separated for data analysis and 
publication purposes.  
 
If Informed Consent is not obtained for initial data entry of retrospective patients and if the patient returns 
for follow-up or if follow-up data is otherwise obtained, Informed Consent can be obtained at follow-up. 
 
If practical, obtaining Informed Consent from both retrospective and prospective patients is highly 
encouraged. 
 
8 
Forms 
The RSSearch Registry includes the following forms and is available upon request: 
 
• 
Screening Form 
• 
Treatment Plan Form 
• 
Follow-up Form 
• 
Quality of Life Questionnaires 
 
The registry contains both required and optional data fields, but it is highly recommended that all data 
fields, including required and optional fields be entered into RSSearch. 
 
 
Screening Form 
On the Screening Form, information is entered about any patient who is screened for treatment. 
 
A new Screening Form is initiated and used for: 
 
▪ 
New patients who have not previously been treated with SRS/SBRT/SFRT 
▪ 
Existing patients who have previously been treated with SRS/SBRT/SFRT and 
o Have a recurrence or need for additional treatment at a previously treated target location, or 
o Have a new target treatment location or locations 
▪ 
Existing patients who have previously been screened, but not treated by SRS/SBRT/SFRT 
▪ 
Patients who are screened and not selected for SRS/SBRT/SFRT  
 
If a patient has more than one target treatment location that will be treated during a single treatment 
period, details on these individual treatment locations will be recorded on the Screening Form. 
 

 
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If patients are screened and not selected for SRS/SBRT/SFRT, some basic information is entered including 
treatment location, referring physician and the reason why one of these systems was not selected for this 
patient at this time. 
 
If patients are screened and selected for SRS/SBRT/SFRT treatment, the basic information mentioned 
above as well as the following additional information is entered; relevant patient characteristics and 
health status; detailed diagnostic information; and some information on reimbursement. 
 
Treatment Plan Form 
The Treatment Plan Form is filled out for every patient selected for SRS/SBRT/SFRT treatment. The design 
of the Treatment Plan Form follows typical treatment approaches, where a single treatment plan may be 
used to treat one or more lesions and multiple treatment plans may be used to treat a single target 
location.  Clinicians will record one or more treatment plans and lesion details on a single Treatment Plan 
Form for any particular treatment period. 
 
General Treatment Planning Systems (TPS) information can be digitally uploaded into RSSearch using an 
automated feature in VisionTree Optimal Care (VTOC) database platform (VisionTree, San Diego, CA, 
www.visiontree.com) the developer of the database platform used for RSSearch.  This feature reduces 
the amount of duplicate data entry by participating sites while providing key information to meet the 
RSSearch Patient Registry objectives.   
 
SRS/SBRT/SFRT systems not supported by system manufacturers may require manual entry of certain 
treatment planning information. 
 
Treatment Plan Forms will be linked electronically within the database to patients, target treatment 
locations and lesions to assist with proper tracking for outcomes analysis. 
 
Follow-Up Form 
The Follow-Up Form is used to document the result of each treatment plan. 
 
Follow-Up Forms are used at intervals determined appropriate by individual clinical sites.  Data is recorded 
after patients attend regularly scheduled follow-up appointments.  Patients are expected to be followed 
as long as they are deemed candidates for follow-up. 
 
Follow-Up Forms will be linked electronically to patients and target treatment locations, lesions and 
treatment plans to assist with proper follow up and outcomes analysis. 
 
Patient Quality of Life and other Patient-Reported Outcomes Forms 
 
The patient quality of life questionnaires are optional and may be used if your institution wishes to collect 
these data.  However, we are actively encouraging participants to collect quality of life data.  The patient 
quality of life forms have been reviewed by the RSSearch Advisory Committee and are available and visible 
in the “Patient To Do’s” Tab of the Registry.  Many of the patient quality of life questionnaires are standard 
forms, validated and used to collect these kinds of data.  A list of available quality of life and patient-
reported outcomes forms are in Appendix E. 
 
There are two approaches to reporting patient quality of life-data:  1) Via a secure VisionTree Patient 
Portal which automates the process by using the patient’s email and your institution’s selected forms of 

 
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interest.  Patients will only be able to access their specifically assigned QOL forms.  2) Centers can manually 
enter patient-reported outcomes data through the Medical Team Portal.  Forms can be printed from the 
VisionTree system, completed by the patient and then the medical team can enter the information directly 
into RSSearch. 
 
9 
Data Recording 
The data recorded in the course of this registry will be documented on electronic case report forms 
(eCRFs) within a secure web-enabled software application.  An independent medical software and web 
management company, VisionTree, San Diego, CA (www.visiontree.com), Inc. has designed and is 
managing the database and maintaining a HIPAA compliant system. 
 
The system requires all information that is transmitted across the Internet be encrypted via Hyper Text 
Transfer Protocol Secure (HTTPS).  To help avoid unauthorized usage, an automatic log-off feature is 
utilized after an extended period of user inactivity.  A role-based security model is implemented to restrict 
access to various segments of the system (i.e. reports, screens, and site-specific data, along with other 
identified restricted information).  In addition, the user interface and application components are stored 
behind an industry standard firewall with all outside communication closed except HTTP, HTTPS and 
Virtual Private Network (VPN) communication, while the database is only accessible via the internal 
network and VPN access.  The system is physically housed within a HIPAA compliant facility including 
network redundancy for data availability, 24/7 network monitoring, multilevel access control requiring 
Badge/Photo ID and biometric access screening, internal and external video monitoring, fire protection, 
and disaster and environmental controls.  The server and network updates are managed by 
VisionTree.  The system data is backed up daily. 
 
10 Patient Confidentiality 
A unique patient identification number created and known only to your participating facility should be 
utilized in RSSearch and not a Medical Record Number.  This data field is considered a “private” field and 
available only to the clinical site entering that data.  The patient identification number will be used only 
as required for registry operations, specifically: 
 
▪ 
To assist in enabling the digital import of treatment plan data from various Treatment Planning 
Systems, automatically and accurately linking the data  
▪ 
To assist in enabling the digital import of data currently being collected in electronic form by 
participating clinical sites 
▪ 
To make it easier for individuals at participating clinical sites to find a specific patient to enter 
additional data, to modify previously entered data and to record follow up data 
  
As an additional security measure, a randomly generated patient ID is generated by VisionTree and linked 
to the unique patient ID created by the individual sites.  This randomly generated ID can be used by 
VisionTree and the RSS to communicate with you if necessary, about specific patients.  See Section 9 above 
to see how the limited PHI entered into RSSearch will be managed and protected by the software 
application and services provided by VisionTree. 
 
Some payer and payment information is being collected to help gain insight into reimbursement of 
SRS/SBRT/SFRT treatment for different diagnoses by different health plans.  Individual patient health plan 
numbers are not included in the database. 
 

 
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Patient email addresses may be collected by individual sites to allow patients to access the Patient Portal 
in order to view and complete select Quality of Life forms.  If email addresses are collected for this 
purpose, these emails are only visible to the individual site and will be protected by the software 
application processes put in place by VisionTree. 
 
All patient data will be de-identified prior to use for research and analysis.  If and when comparisons of 
aggregate data are made, no specifically identified patient-to-patient, physician-to-physician or 
geographic comparisons of data will be performed. 
 
11 Security 
Participants will be required to enter a unique username and password to access the RSSearch Patient 
Registry. No sharing of usernames and passwords will be allowed. 
 
If a clinical site determines they need written copies of RSSearch Data Collection Forms, these should be 
managed in accordance with data protection regulations by that clinical site. 
 
12 Reporting 
Participants may routinely access reports of their own individual center’s data and are free to publish their 
own data at any time.  The particular research and methods must be evaluated for scientific merit and 
ethical propriety by their own institutions. Publications or presentations that result from the RSSearch 
Registry should be acknowledged accordingly. 
 
The RSSearch Registry Review Committee (RRRC) composed of SRS/SBRT/SFRT users may review and 
release de-identified aggregate data as deemed appropriate for publication. Any individual participating 
site may choose to have their data included or excluded in the released aggregate data, but because 
aggregate data will not contain any identifiers, either patient, physician or site, all participating sites will 
be encouraged to include their data to increase the value for educational purposes.  Participating 
sites/clinicians and the RSS may submit requests for aggregate data for publication to the expert review 
panel. Please see Appendix D for details on aggregate reporting. 
 
13 IRB/Ethics Review Committee Approval 
IRB or Ethics Review Committee review and approval is required to participate in the RSSearch Registry 
(see Appendix A for review considerations).  
 
Patient Informed Consent 
Obtaining Patient Informed Consent for prospective patients being entered into the database is required 
and is highly suggested for retrospective patients; since increasingly, peer reviewed publications require 
Informed Consent for submitted research.  A sample Patient Consent Form is attached in Appendix B.  For 
institutions that require a patient research authorization to collect patient data prospectively, a sample 
Patient Authorization Form is attached in Appendix C. 
 
14 Risks/Benefits 
There are no specific risks to patients of having limited patient information collected in a central database. 
Information entered into RSSearch is currently being collected as a standard part of patient care and 
follow up. 
 

 
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The benefits may include improved follow up for individual patients by participating sites and improved 
understanding of the use and results of SRS/SBRT/SFRT treatment for all patients. 
 
15 Reporting of Adverse Events 
The RSSearch® Patient Registry provides a means on the Follow-Up Form for participating sites to indicate 
if the patient is experiencing any unexpected side effects or adverse events (AE) that can be attributable 
to SRS/SBRT/SFRT treatment.  Reported adverse events will be graded on a scale of 1-5 as defined by the 
published standard Common Terminology Criteria for Adverse Events (CTCAE) v5. 
 
Participation in RSSearch with its AE system does not in any way replace the responsibilities of clinicians 
or sites in reporting adverse events related to any treatment in accordance with all applicable laws and 
regulations including notifying the manufacturer of the associated SRS/SBRT/SFRT device, or medical 
complaints associated with SRS/SBRT/SFRT treatment as soon as possible. 
 
 

 
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16 Appendix A: Institutional Review Board (IRB) and Ethics Review Committee 
Considerations  
 
Aspects to consider in determining what type of review (expedited or full board) application to use 
include: 
 
1. The RSSearch® Patient Registry is not a clinical trial or study, and no investigational device 
exemption (IDE) is required for use of the various SRS/SBRT/SFRT Systems. 
2. Data entered into RSSearch are observational outcomes data, which are already collected as part 
of the medical records for patients undergoing SRS/SBRT/SFRT treatment. 
3. A unique patient identification number (not medical record number) is recorded at the site level, 
is only available to the respective site, and is used for the following purposes: 
a. To match the various Treatment Planning System data 
b. To assist in long term follow up at the participating site 
c. For registry operations 
4. Physician-specific data will only be available to the respective site. 
5. The RSSearch® Patient Registry is being managed in a secure environment by VisionTree®, San 
Diego, CA, an independent developer of web-based registries. 

 
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17 Appendix B: Sample Text for Patient Consent Form  
 
A registry is a databank of information about people who have something in common.  The RSSearch 
Patient Registry is keeping track of information on patients who have been considered for or have 
undergone treatment by various Stereotactic Radiosurgery (SRS), Stereotactic Body Radiation Therapy 
(SBRT), and Spatially Fractionated Radiation Therapy (SFRT – like GRID and LATTICE) methods.  
 
Who is operating the Registry? 
➢ The study is being sponsored and managed by the Radiosurgery Society (RSS), a non-profit 
organization of surgeons, radiation oncologists, physicists, and allied professionals, who are dedicated 
to advancing the science and clinical practice of SRS, SBRT and SFRT. Originally formed in 2002 and 
becoming a non-profit (501c6) in 2008, the RSS today represents clinician members who perform 
SRS,SBRT and SFRT in hospitals and freestanding centers throughout the world.  (See www.therss.org 
for additional information). 
➢ The registry database is being managed by an independent medical database company, VisionTree®, 
San Diego, CA. 
 
What is being asked of you? 
As you and your physician or health care provider at the treatment centers are having a discussion about 
whether SRS/SBRT/SFRT may be used to treat your particular condition, you are being asked to enroll in 
the registry.  If you agree, 
➢ Your physician will record information about you and your care into the registry 
➢ Information about your care will be recorded at significant follow ups and over time 
➢ Your physician and medical team may wish to collect information directly from you about your 
experience with the procedure and health-related qualify of life.  Your medical team may ask you to 
complete a paper quality of life survey that will be maintained with your medical records and then 
the medical team will enter the data into the registry. 
➢ Your physician may offer you the option to access these quality of life surveys directly online via a 
secure website.  If you agree to directly access the website, you will need to provide an email address 
in order to login to the secure website.  You will be sent reminders periodically from VisionTree to 
login, access and fill out your quality of life surveys in the Registry database managed by VisionTree®.   
o If after discussing this with your physician, you choose not to participate in the quality of 
life surveys, your email address will not be collected, and you won’t receive any email 
reminders to fill out your surveys online. 
 
 
What are the possible risks from participating? 
There are no known health risks to participating in this registry. 
  
Your confidential information will be protected as much as possible within the law.  Any Protected Health 
Information recorded in the registry (i.e. zip code, treatment dates, email, etc.) will be encrypted (secure 
against hackers and other unauthorized uses).  This special coding will secure access of your Protected 
Health Information to authorized parties only, like your physician, physician practice and the registry. The 
registry will not include personally identifiable information such as name, medical record number, 
address, or date of birth.  However, for those physicians and patients who choose to access the Patient 
Portal to complete quality of life surveys, your email will be required. 
 

 
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Your email is visible only to your physician and physician’s practice and like the other confidential 
information will be encrypted to help make sure that unauthorized access to this information does not 
occur. 
 
  
As a function of managing the registry, a registry monitor may be exposed to certain personally 
identifiable information through interaction with your physician’s practice; however, such information 
will only be used for quality control purposes and not be collected or used in any other way by the registry. 
 
Aggregated and de-identified information from the patients participating will be used for analysis, 
publications, and reports. 
 
Are there any possible benefits from participating? 
You may not obtain a direct benefit from being in this registry.  However, patients in the future may 
benefit from the information obtained from this research. 
 
Financial considerations: 
➢ There are no costs to participate in the registry. 
➢ There will be no impact on the costs of your care. 
➢ You will not be provided payment for participating in this registry. 
 
Who can I talk to if I have questions? 
Your first choice should be to talk with your physician who is a study investigator.  He or she should be 
able to discuss the study, your participation, and your rights as a subject.  If you have any other questions 
that you don’t wish to talk about with your physician, you may call the independent review board that 
reviewed this study.  They are this institution’s review board. 
 
AGREEMENT and CONSENT 
If you agree to be in this registry, please sign this form. 
➢ Your decision to be in this registry is voluntary. 
➢ You will not be penalized or lose benefits if you decide not to participate or decide to stop 
participating. 
➢ You may cancel your permission to participate in this research at any 
You will receive a copy of this form signed by both of us. 
 
 
Participant 
Investigator or designee 
 
Having read the above, I agree to 
participate 
I have discussed this with this person 
Signature 
 
 
Printed Name 
 
 
Date/Time 
 
 
 

 
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18 Appendix C: Sample Registry Authorization form 
 
USE AND DISCLOSURE OF YOUR 
INFORMATION ENTERED INTO THE REGISTRY 
 
Principal Investigator:      <name of principle investigator, MD> 
Title: RSSearch® Patient Registry 
 
This form is called an Authorization and relates to use and disclosure of your health information in this 
research project which is an observational database.  You also have been given a Consent form that tells 
you about the research and any activities or procedures that are part of the project.  By signing this form, 
you agree that health information that identifies you may be used as necessary for the registry. 
 
1. 
What information about you may be used or given out for the Registry? 
 
Information that identifies you and might relate to your health or medical condition may be used in this 
registry.  Information that identifies you can include your personal health information (PHI) consisting of 
dates and zip code.  Information that relates to your medical condition includes: 
 
• 
Information that you share with us, including information about your health history  
• 
Information obtained during the normal course of treatment, such as what treatment is 
prescribed and delivered to you, how you respond to treatment(s) and/or procedure(s), 
information we learn in study visits, phone calls, surveys, physical examinations, x-rays and other 
tests and any other medical information we learn from you while conducting this registry. 
• 
Your email address only if you are accessing the VisionTree Patient Portal to complete online 
quality of life questionnaires. 
 
2. 
What information about you may not be used or given out for the Registry? 
 
• 
Your name, Social Security number, medical record number, face photo/images, or unique 
identifying number/codes, except the unique code assigned by the investigator to code the data, 
will not be recorded in the Registry. 
 
3. 
Who may use and give out information about you? 
 
Your physician and other health care providers may provide the physical health and treatment 
information required for this registry.  These include the researcher and the research staff, <name of the 
Treatment Center> and other physician practices and/or hospitals where you might be seen during your 
course of treatment by and follow up of SRS/SBRT/SFRT treatment.  
 
4. 
Who may see your information? 
 
Certain individuals/departments may see your health information to conduct the registry and to make 
sure it is being done as it should. These include: 
 
• 
The Institutional Review Board (IRB) 
• 
People who are responsible for research and HIPAA oversight at the institution(s) where the 
research is conducted 

 
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• 
Health care providers who may provide treatment to you during your participation in the registry 
• 
People involved in ongoing management of registry operations 
 
5. 
How will this information be used? 
 
• To track treatment over time. 
• To determine how care is being delivered. 
• Your information will be used as part of research purposes. 
 
6. 
Is your health information protected after it has been given to others? 
 
Your specific identified health information will never be shared with an entity not covered by these 
policies and laws.  This includes the registry sponsor, and other entities with whom the sponsor contracts 
to work on the registry. 
 
7. 
What if you decide not to give your permission to use and give out your health information? 
 
You do not have to give your permission to use or give out your health information. Your treatment will 
not be affected in any way if you refuse your permission. 
 
8. 
May you withdraw or cancel your permission? 
 
You may cancel your agreement to allow your health information to be used or given out at any time by 
completing a written Revocation Form and forwarding it to the___________.  A Revocation Form may be 
obtained from your physician.  If you have any questions, call ___________.  If you revoke your 
authorization, you are leaving the registry.  If you leave the Registry, no new health information about 
you will be gathered after that date.  However, information gathered before that date may be used for 
the registry or any follow-up for the registry. 
 
9. 
Does this authorization have an end date? 
 
There is no expiration date for this research authorization. 
 
10. 
Have you given up any legal rights by signing this form? 
 
By signing this authorization form, you have not waived any of the legal rights you would have were you 
not in the registry. 
 
 
FOR ADULTS CAPABLE OF GIVING AUTHORIZATION: 
 
___________________________________________________________________________________________ 
 
 
 
Subject's Signature                                                                                  Date Signed 
 
___________________________________________________________________________________________ 
 
 
 
Printed Name 
 
    NOTE: THE PRINCIPAL INVESTIGATOR MUST: 
• 
PROVIDE A COPY OF THE SIGNED AUTHORIZATION TO THE SUBJECT 
• 
RETAIN THE ORIGINAL SIGNED AUTHORIZATION IN THE RESEARCH RECORD 

 
RSSearch® Patient Registry Protocol  
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• 
PLACE A COPY OF THE SIGNED AUTHORIZATION IN THE SUBJECT’S MEDICAL RECORD 

 
RSSearch® Patient Registry Protocol  
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19 Appendix D: Access to Data and Aggregate Reporting 
 
Overview 
This guideline provides information on the specific and accepted professional use of data and database-
derived information of the RSSearch® Patient Registry. 
 
Use of Data 
Participants:  RSSearch® Patient Registry “Participants” may consist solely of one or more physicians, 
physicists, nurses and site administrators, plus their hospital or center, at the physician’s election, who 
engage in the process of collecting clinical practice data and utilization of data-base derived information. 
 
Participants may routinely access reports of their own individual center’s data and are free to publish their 
own data at any time.  The particular research and methods must be evaluated for scientific merit and 
ethical propriety by their own Institutional Review Board or Ethic Review Committee. 
 
Any individual participating site may choose to have their data included or excluded in the released 
aggregate data, but because aggregate raw data will not contain any identifiers, either patient, physician 
or site, all participating sites will be encouraged to include their data to increase the value for educational 
purposes.  Participating sites/clinicians and the RSS may submit requests for aggregate data for 
publication for expert review panel. 
 
Registry Administrator:  The RSSearch® Patient Registry Administrators are the RSS employees, who are 
responsible for managing the development and maintenance of the registry.  The responsibilities of the 
Administrators include: 
• 
Oversee the management, development and maintenance of the database 
• 
Providing participants with the most recent updated registry protocol, sample 
consent form and supporting materials for IRB, Ethics Review Committee or 
regulatory agency equivalent submission 
• 
Acting as a liaison between the participants and the database vendor 
• 
Creating and editing Data Collection Forms 
• 
Notifying the database vendor of new participants or changes user access 
• 
Coordinating database training 
• 
Create and distribute timely reports of limited aggregate data under advisement of 
the RRRC 
• 
Review and process applications for access to aggregate data 
• 
May create, distribute and report on aggregate data and Quality Assurance and 
Performance Improvement studies with prior approval by the RSSearch® Patient 
Registry Review Committee (RRRC) 
 
The Administrator will have read only access to de-identified registry data.  All physician and specific 
patient identifying information will be restricted and not visible to the Administrator. 
 
Aggregate Data Reporting: The RSSearch® Registry Review Committee (RRRC) will periodically review 
opportunities for presenting topline aggregate data to all participants via the Registry. 
 
Access to data for publication and presentation: Data entered into the registry is available for research 
and publications.  Clinical research on aggregated data may be used to produce one or more of the 
following forms of reporting and dissemination of information: abstract, scientific meeting presentation, 

 
RSSearch® Patient Registry Protocol  
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manuscript for publication in the medical literature. Patient identifying information will remain 
confidential. 
 
All publications will include reference to all participating RSSearch® sites.  Researchers will be provided 
assistance in getting permission to be named in a publication by the RSSearch Administrator. 
 
RSSearch® Registry Review Committee (RRRC): 
The RRRC consists of clinicians with extensive SRS and SBRT experience that have been selected by RSS 
Board of Directors.  The RRRC evaluates the proposals based on originality, interest and benefit to the 
entire SRS and SBRT community and feasibility (as defined by availability of data in the aggregate 
database).  
 
All persons interested in publishing RSSearch® aggregate data must submit their proposal for publication 
and 
request 
for 
data 
analyses 
to 
the 
RRRC 
using 
the 
RSSearch® 
Request  
For Use of Aggregate Data Form (see Attachment D.1). The Radiosurgery Society® will submit requests 
for aggregate data for publication to the RRRC. The RRRC will review individual applications for aggregate 
data release.  There is no fee to submit an application for RRRC. 
 
As indicated above and throughout the document, no physician, patient, or site identifying information is 
available or will be made available in granted requests for aggregate data.  Site identifying information 
will be provided to the Radiosurgery Society for purposes of aggregate study requests and for conducting 
quality assurance of the database. 
 
RSSearch® Data Request Form for Use of Aggregate Data: 
 
Eligibility Criteria for Participating Centers 
(The RSS will not be held to below criteria) 
• 
Enter > 50 patients into RSSearch® annually 
• 
Principal Investigator must be an RSS member 
• 
The RSS will not be held to this criterion 
 
Submission Requirements 
Please attach each of the following with your RSSearch® Request For Use of Aggregate Data Form: 
• 
Copy of IRB approval letter for use of RSSearch® at your institution 
• 
Curriculum vitae of the principal investigator 
• 
The RSS will not be held to this criterion 
 
General Information 
Submit Appendix D: Access to Data and Aggregate Reporting to the RSS RSSearch Administrator at 
jdavis@therss.org You will receive a letter regarding the status of your request within 30 business days. 
Requested custom aggregate data report will require a minimum of 2 weeks to generate. 
. 
 
 
 

 
RSSearch® Patient Registry Protocol  
Version Date: 7/19/2022 Version 1.1 
 
Request For Use of Aggregate Data Form  
 
Date of Submission (mm/dd/yy): 
 
Name of Organization: 
 
 
Project Title: 
 
 
Principal Investigator: 
 
 
Co-Investigators: 
 
 
Corresponding Contact Name: 
 
 
Contact Title: 
 
 
Contact Telephone Number: 
 
 
Contact E-mail Address: 
 
 
Contact Address: 
City, State, Zip: 
 
 
 
 
Project Description 
Project Start Date (mm/dd/yy): 
 
Project End Date (mm/dd/yy): 
 
Type of Research Project: 
□ Prospective Study 
□ Retrospective Analysis 
□ Technical Study 
□ Other 
If “Other,” please explain nature of 
project: 
 
 
What is the research question being 
asked?  
 
 
 
What is the background or rationale for 
the research question? (if needed, please 
attach as a separate page to application) 
 
Patient Inclusion/Exclusion Criteria: 
 
 
Data Requested 
Description of patient population to be 
analyzed: 
 
 
Time frame to be studied: 
 
List exact data variables requested (i.e. 
pathology, 
treatment 
planning 
 

 
RSSearch® Patient Registry Protocol  
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information, outcome, reimbursement, 
etc.):  If the request is not self-evident, 
write a summary of the request and/or 
instructions on data output (e.g., table 
specifications, sample tables). 
Deadline for receipt of data (mm/dd/yy): 
 
 
Data Use 
Are these data for internal research 
purposes only? (yes/no) 
 
If requesting party will seek to share data 
with persons not already listed on this 
request, list the organizations with which 
data would be shared and in what 
capacity? (e.g., FDA for a clinical trial, NIH 
for a grant proposal, consultant for project 
development) 
 
Peer-reviewed publications to which 
submission is anticipated (if any) 
 
National meetings at which abstract 
presentation is anticipated (if any) 
 
 
Additional Submission Requirements 
Please attach each of the following: 
• 
Copy of IRB approval letter for use of RSSearch® at your institution 
• 
Curriculum vitae of the principal investigator 
 
Requestor Certification 
In making this request, I certify that: 
• 
All information provided on this form and attachments is accurate and complete; 
• 
I have all requisite institutional authority to submit this Request for Use of Collaborative Data 
 
 
 
Signature 
 
 
 
Print Name 
 
 
 
Title 
 
 
 
Date 
 
 
Please submit Request for Use of Collaborative Data to jdavis@therss.org 
For Internal Use Only: 
Date application received: 
 

 
RSSearch® Patient Registry Protocol  
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RSSearch Registry Request # 
 
  
20 Appendix E: Health-Related Quality of Life Questionnaires 
 
Form Name 
Reference 
GoogleDoc URL 
Actual Life 
Changes in 
Epilepsy 
 Rose Trial for Radiosurgery or Open Surgery for 
Epilepsy 
 
http://www.igkrf.org/uploads/6/6/3/7/66377631
/13-01.pdf 
https://drive.google.com/file/d/0B_Fo8tKvsaUyTUJyZFNvbF
Zud3M/view?usp=sharing  
BCPT - 
Everyday 
Problems 
During The 
Past 4 
Weeks 
 Life After Breast Cancer: Understanding 
Women's Health-Related Quality of Life and 
Sexual Functioning By Patricia A. Ganz, Julia 
H. Rowland, Katherine Desmond, Beth E. 
Meyerowitz, and Gail E. Wyatt J Clin Oncol 
16:501-514. © 1998 by American Society of 
Clinical Oncology 
 
 
http://ascopubs.org/doi/pdf/10.1200/jco.1998.1
6.2.501 
https://drive.google.com/a/visiontree.com/file/d/0B_Fo8tK
vsaUyTzBKVE1VZW1Jd1k/view?usp=sharing  
Beck 
Anxiety 
Inventory 
Beck, A. T.,Epstein, N.,Brown, G.,Steer, R. A. 
(1988). An inventory for measuring clinical 
anxiety: Psychometric properties.Journal of 
Consulting and Clinical Psychology, 56,893-897. 
https://drive.google.com/file/d/0B_Fo8tKvsaUyalhHU1lla3
RvNzQ/view?usp=sharing  
Bladder 
Cancer 
Index (BCI) 
Development and Validation of the Bladder 
Cancer Index: 
Scott M. Gilbert, Rodney L. Dunn, Brent K. 
Hollenbeck,* James E. Montie, 
Cheryl T. Lee,† David P. Wood‡ and John T. Wei§. 
A Comprehensive, Disease Specific Measure of 
Health Related 
Quality of Life in Patients With Localized Bladder 
Cancer.  Journal of Urology Vol. 183, 1764-1770, 
May 2010. 
https://drive.google.com/a/visiontree.com/file/d/0B_Fo8tK
vsaUyZ3c2VmFybkIyNjQ/view?usp=sharing  
Breast 
Cancer 
Treatment 
Outcomes 
Scale 
 BCTOS in measuring HR-QOL after breast 
conserving therapy: Chen et al.  The Breast 
Journal, Volume 17, Number 4, 2011 443l Feb 
2014  
 
https://www.researchgate.net/publication/5148
8510_BCTOS_in_measuring_HR-
QoL_after_breast-conserving_therapy 
https://drive.google.com/a/visiontree.com/file/d/0B_Fo8tK
vsaUyeFdFOWlFN2JGUUE/view?usp=sharing  
Breast 
Symptom 
Survey 
Modifed from and used by UCLA Breast 
Registry:  The BCPT Symptom Scales: A 
Measure Symptoms for Women 
Diagnosed With or at Risk for Breast 
Cancer. Stanton et al. JNCI Accepted 
January 18 2005 
http://apntoolkit.mcmaster.ca/index.php?option
=com_content&view=article&id=137:br
east-cancer-prevention-trial-bcpt-
symptom-checklist&Itemid=58 
https://drive.google.com/a/visiontree.com/file/d/0B_Fo8tK
vsaUyczZxekZzd3dSbnM/view?usp=sharing  

 
RSSearch® Patient Registry Protocol  
Version Date: 7/19/2022 Version 1.1 
 
Brief COPE 
Informant 
Carver, C. S.  (1997).  You want to measure coping 
but your protocol’s too long:  Consider the Brief 
COPE. International Journal of Behavioral 
Medicine, 4, 92-100. 
https://drive.google.com/file/d/0B_Fo8tKvsaUyYVZmU1FjQ
zhXanc/view?usp=sharing  
Brief COPE 
Patient 
Carver, C. S.  (1997).  You want to measure coping 
but your protocol’s too long:  Consider the Brief 
COPE. International Journal of Behavioral 
Medicine, 4, 92-100. 
https://drive.google.com/file/d/0B_Fo8tKvsaUyZmVlWm5O
aWJJak0/view?usp=sharing  
Caregiver 
Reaction 
Assessment 
Scale 
Given CW, Given B, Stommel M, et al. The 
caregiver reaction assessment (CRA) for 
caregivers to persons with chronic physical and 
mental impairments. Research in Nursing & 
Health. 1992; 15: 271-283. 
https://drive.google.com/file/d/0B_Fo8tKvsaUyb25nTlhrbD
FhSEk/view?usp=sharing  
CESD 
Depression 
Inventory 
Radloff LS. The CES-D scale: a self-report 
depression scale for research in the general 
population. Applied Psychological Measurement. 
1977;1:385-401. 
https://drive.google.com/file/d/0B_Fo8tKvsaUyZU5HbWp
MMFRpcms/view?usp=sharing  
Coping 
Strategy 
Indicator 
(CSI) Scale 
(Patinet 
and 
Spouse/Par
tner) 
Amirkhan, J. H. (1990). A factor analytically 
derived measure of coping: The Coping Strategy 
Indicator. Journal of Personality and Social 
Psychology, 59, 1066-1075. 
https://drive.google.com/a/visiontree.com/file/d/0B_Fo8tK
vsaUyMlFReGw5MG9VLXM/view?usp=sharing  
EORTC 
QLQ- BR23 
Sprangers MA, Groenvold M, Arraras JI, Franklin J, 
te Velde A, Muller M, Franzini L, Williams A, de 
Haes HC, Hopwood P, Cull A, Aaronson NK. The 
European Organization for research and 
treatment of cancer breast cancer-specific 
quality-of-life questionnaire module: first results 
from a three-country field study. J Clin Oncol. 
1996;14:2756–2768. 
  
EORTC QLQ 
H&N35 
Sherman AC1, Simonton S, Adams DC, Vural E, 
Owens B, Hanna E. Assessing quality of life in 
patients with head and neck cancer: cross-
validation of the European Organization for 
Research and Treatment of Cancer (EORTC) 
Quality of Life Head and Neck module (QLQ-
H&N35). Arch Otolaryngol Head Neck Surg. 2000 
Apr;126(4):459-67 
  
EORTC 
QLQ-C30 
(version 3) 
Aaronson N.K., Ahmedzai S., Bullinger M. et al: 
The EORTC core quality of life questionnaire: 
Interim results of an international field study. In: 
Osoba D. ed. Effect of Cancer on Quality of Life. 
Boca Raton, FL: CRC Press 1991: 185-203 
https://drive.google.com/a/visiontree.com/file/d/0B_Fo8tK
vsaUyd2hGMTNIOURtaU0/view?usp=sharing  
EORTC-
QLQ-BN20 
Taphoorn MJ1, Claassens L, Aaronson NK, Coens 
C, Mauer M, Osoba D, Stupp R, Mirimanoff RO, 
van den Bent MJ, Bottomley A; EORTC Quality of 
Life Group, and Brain Cancer, NCIC and 
Radiotherapy Groups. An international validation 
study of the EORTC brain cancer module (EORTC 
QLQ-BN20) for assessing health-related quality of 
life and symptoms in brain cancer patients. Eur J 
Cancer. 2010 Apr;46(6):1033-40 
https://drive.google.com/file/d/0B_Fo8tKvsaUySTJ5YkwxSX
JIa2M/view?usp=sharing  
EPIC 
(Expanded 
Prostate 
Cancer 
Development and Validation of the Expanded 
Prostate Cancer Index Composite (EPIC) for 
Comprehensive Assessment of Health-Related 
https://drive.google.com/a/visiontree.com/file/d/0B_Fo8tK
vsaUyeVhFUHRLWXhveXc/view?usp=sharing  

 
RSSearch® Patient Registry Protocol  
Version Date: 7/19/2022 Version 1.1 
 
Index 
Composite) 
Quality of Life in Men with Prostate Cancer", 
Urology. 56: 899-905, 2000. 
EPIC-26 
(Expanded 
Prostate 
Cancer 
Index 
Composite) 
https://medicine.umich.edu/sites/default/files/c
ontent/downloads/epic26web.pdf  
https://drive.google.com/a/visiontree.com/file/d/0B_Fo8tK
vsaUyOWJZVjJoRUQ2cEk/view?usp=sharing  
Erectile 
Score 
Questionair
e 
Used by the FROG group—derived from other 
standard measurement tools 
https://drive.google.com/a/visiontree.com/file/d/0B_Fo8tK
vsaUyclJ6bDEzYl83T2c/view?usp=sharing  
Everyday 
Cognition 
Scale 
Sarah Tomaszewski Farias, Dan Mungas, Bruce R. 
Reed, Deborah Cahn-Weiner, Kathleen Baynes, 
Charles DeCarli. The Measurement of Everyday 
Cognition (ECog): Scale Development and 
Psychometric Properties. Neuropsychology. 2008 
Jul; 22(4): 531–544.  
https://drive.google.com/file/d/0B_Fo8tKvsaUydzdnMGItZ
EVZWVU/view?usp=sharing  
FACT E 
Darling et al. Validation of the Functional 
Assessment of Cancer Therapy Esophageal Cancer 
Subscale, Cancer 2006;107:854–63. 
https://drive.google.com/a/visiontree.com/file/d/0B_Fo8tK
vsaUyUldRUjEyeng3ZXM/view?usp=sharing  
FACT En 
Hopp EE1, Osborne JL2, Schneider DK3, Bojar CJ4, 
Uyar DS4. A prospective pilot study on the 
incidence of post-operative lymphedema in 
women with endometrial cancer. Gynecol Oncol 
Rep. 2015 Dec 24;15:25-8 
https://drive.google.com/a/visiontree.com/file/d/0B_Fo8tK
vsaUyVHJCMWpfZUNzeGM/view?usp=sharing  
FACT Ga 
Garland SN1, Pelletier G, Lawe A, Biagioni BJ, 
Easaw J, Eliasziw M, Cella D, Bathe OF. 
Prospective evaluation of the reliability, validity, 
and minimally important difference of the 
functional assessment of cancer therapy-gastric 
(FACT-Ga) quality-of-life instrument. Cancer. 
2011 Mar 15;117(6):1302-12 
https://drive.google.com/a/visiontree.com/file/d/0B_Fo8tK
vsaUycFBGZ0R2anM2eWc/view?usp=sharing  
FACT Hep 
Cella D, Butt Z, Kindler HL, Fuchs CS, Bray S, 
Barlev A, Oglesby A. Validity of the FACT 
Hepatobiliary (FACT-Hep) questionnaire for 
assessing disease-related symptoms and health-
related quality of life in patients with metastatic 
pancreatic cancer. Qual Life Res. 2013 
Jun;22(5):1105-12 
https://drive.google.com/a/visiontree.com/file/d/0B_Fo8tK
vsaUydVpEQUp0SENTVWs/view?usp=sharing  
FACT-BR v4 
Thavarajah N, Bedard G, Zhang L, Cella D, 
Beaumont JL, Tsao M, Barnes E, Danjoux C, 
Sahgal A, Soliman H, Chow E. Psychometric 
validation of the functional assessment of cancer 
therapy--brain (FACT-Br) for assessing quality of 
life in patients with brain metastases.  Support 
Care Cancer. 2014 Apr;22(4):1017-28. 
https://drive.google.com/file/d/0B_Fo8tKvsaUyanF3dl9CNk
tOVTA/view?usp=sharing  
FACT-Cog 
(v3) 
Vardy J1, Wong K, Yi QL, Park A, Maruff P, 
Wagner L, Tannock IF. Assessing cognitive 
function in cancer patients. Support Care Cancer. 
2006 Nov;14(11):1111-8 
https://drive.google.com/file/d/0B_Fo8tKvsaUyT2NTc2hFR
nlHQjA/view?usp=sharing  
FACT-Cx 
(English w/ 
Spanish 
drop-down 
option) 
McQuellon R, Thaler H, Cella D, Moore DH. 
Quality of life (QOL) outcomes from a randomized 
trial of cisplatin versus cisplatin plus paclitaxel in 
advanced cervical cancer: a Gynecologic 
Oncology Group study. Gynecol Oncol. 
2006;101:296–304 
https://drive.google.com/a/visiontree.com/file/d/0B_Fo8tK
vsaUyelkxaEhsZy0yU0U/view?usp=sharing  
FACT-G 
 Luckett, T.; King, M. T.; Butow, P. N.; Oguchi, M.; 
Rankin, N.; Price, M. A.; Hackl, N. A.; Heading, G. 
https://drive.google.com/a/visiontree.com/file/d/0B_Fo8tK
vsaUyOGprOHBTUm1fblU/view?usp=sharing  

 
RSSearch® Patient Registry Protocol  
Version Date: 7/19/2022 Version 1.1 
 
(2011-02-21). "Choosing between the EORTC 
QLQ-C30 and FACT-G for measuring health-
related quality of life in cancer clinical research: 
issues, evidence and recommendations". Annals 
of Oncology: mdq721. 
doi:10.1093/annonc/mdq721. ISSN 0923-7534. 
PMID 21339384 
FACT-H&N 
(Version 4) 
List MA, D’Antonio LL, Cella DF, et al. The 
Performance Status Scale for Head and Neck 
Cancer Patients and the Functional Assessment of 
Cancer Therapy-Head and Neck Scale. A study of 
utility and validity. Cancer. 1996;77:2294–2301 
https://drive.google.com/file/d/0B_Fo8tKvsaUyT0dxYWtY
MVRtT1k/view?usp=sharing  
FACT-Trial 
Outcome 
Index (TOI) 
for Lung 
Cancer 
Cella, D.F., Bonomi, A.E., Lloyd, S.R. et al. 
Reliability and validity of the FACT-L quality of life 
instrument.  Lung Cancer 12(3): 199-220, 1995.  
https://drive.google.com/a/visiontree.com/file/d/0B_Fo8tK
vsaUyMllBQVpRN3NfUzA/view?usp=sharing  
Fear of 
Cancer 
Recurrence 
Inventory - 
Baseline 
Simard S1, Savard J. Fear of Cancer Recurrence 
Inventory: development and initial validation of a 
multidimensional measure of fear of cancer 
recurrence. Support Care Cancer. 2009 
Mar;17(3):241-51 
https://drive.google.com/a/visiontree.com/file/d/0B_Fo8tK
vsaUyMVRLeXAxOUFqYVk/view?usp=sharing  
Female 
Pelvis 
Symptom 
Survey 
 Modified and used by UCLA Radiation Oncology 
Group 
https://drive.google.com/a/visiontree.com/file/d/0B_Fo8tK
vsaUyX21UWXNqWlA4Sms/view?usp=sharing  
FSS 
(Fatigue 
Severity 
Scale) 
Krupp LB. The fatigue severity scale. Application 
to patients with multiple sclerosis and systemic 
lupus erythematosus. Arch Neurol. 
1989;46:1121–3. 
https://drive.google.com/file/d/0B_Fo8tKvsaUyUUVEUmkz
X0QzbW8/view?usp=sharing  
Global 
Health 
Scale - 
Baseline 
2008-2012 PROMIS Health Organization and 
PROMIS Cooperative Group             
https://drive.google.com/a/visiontree.com/file/d/0B_Fo8tK
vsaUyVXRINzNIejBkVEU/view?usp=sharing  
Head and 
Neck 
Symptom 
Survey 
Modified and used by UCLA Radiation Oncology 
Group 
https://drive.google.com/file/d/0B_Fo8tKvsaUyZm9jRlZiVH
RVMWs/view?usp=sharing  
IIEF (Not 
Sexually 
Active) 
Rosen RC, Cappelleri JC, Smith MD, et al. 
Development and evaluation of an abridged, 5-
item version of the International Index of Erectile 
Function (IIEF-5) as a diagnostic tool for erectile 
dysfunction. Int J Impot Res. 1999 Dec;11(6):319-
26 
https://drive.google.com/a/visiontree.com/file/d/0B_Fo8tK
vsaUyZ0NPNW9PNmxuUjA/view?usp=sharing  
IIEF 
(Sexually 
Active) 
Rosen RC, Cappelleri JC, Smith MD, et al. 
Development and evaluation of an abridged, 5-
item version of the International Index of Erectile 
Function (IIEF-5) as a diagnostic tool for erectile 
dysfunction. Int J Impot Res. 1999 Dec;11(6):319-
26 
https://drive.google.com/a/visiontree.com/file/d/0B_Fo8tK
vsaUyaDdKR3FMYWlRUE0/view?usp=sharing  
IPSS (Pre-
Treatment) 
Barry MJ, Fowler FJ Jr, O'Leary MP, Bruskewitz 
RC, Holtgrewe HL, Mebust WK, Cockett AT. The 
American Urological Association symptom index 
for benign prostatic hyperplasia. 
The Measurement Committee of the American 
Urological Association. J Urol 1992 
Nov;148(5):1549-57. 
https://drive.google.com/a/visiontree.com/file/d/0B_Fo8tK
vsaUyVzNzQzNKTHhqX2c/view?usp=sharing 
M.D. 
Anderson 
Cleeland CS1, Mendoza TR, Wang XS, Chou C, 
Harle MT, Morrissey M, Engstrom MC. Assessing 
https://drive.google.com/file/d/0B_Fo8tKvsaUydlgta2ZFd1
pYVHc/view?usp=sharing  

 
RSSearch® Patient Registry Protocol  
Version Date: 7/19/2022 Version 1.1 
 
Symptom 
Inventory 
(MDASI) 
Core Items 
symptom distress in cancer patients: the M.D. 
Anderson Symptom Inventory. Cancer. 2000 Oct 
1;89(7):1634-46 
Male Pelvis 
Symptom 
Survey 
Modified and  Used by UCLA Radiation Oncology 
Group 
https://drive.google.com/a/visiontree.com/file/d/0B_Fo8tK
vsaUyY2FQa0E3TlYyRms/view?usp=sharing  
MDADI 
(dysphagia) 
Chen AY, Frankowski R, Bishop-Leone J, et al. The 
development and validation of a dysphagia-
specific quality-of-life questionnaire for patients 
with head and neck cancer: the M. D. Anderson 
dysphagia inventory. Arch Otolaryngol Head Neck 
Surg 2001;127:870-6. 
https://drive.google.com/file/d/0B_Fo8tKvsaUyYmpheGpK
NlRWZ0k/view?usp=sharing  
MDASI-HN 
Rosenthal DI, Mendoza TR, Chambers MS, et al. 
Measuring head and neck cancer symptom 
burden: The development and validation of the 
M. D. Anderson Symptom Inventory, head and 
neck module. Head Neck 29(10): 923-931, 2007. 
https://drive.google.com/file/d/0B_Fo8tKvsaUydndHWURy
cFJNZW8/view?usp=sharing  
Modified 
Functional 
J.O.A. 
(Japanese 
Orthopedic 
Association
) Scale 
Benzel EC, Lancon J, Kesterson L, Hadden T. 
Cervical laminectomy and dentate ligament 
section for cervical spondylotic myelopathy. J 
Spinal Disord. 1991;4:286–95 
https://drive.google.com/file/d/0B_Fo8tKvsaUyeklYMENm
RkpHM0k/view?usp=sharing  
Modified 
PROLO 
Scale 
(Spine) 
Prolo D, Oklund SA, Butcher M (1986) Toward 
uniformity in evaluating results of lumbar spine 
operations. A paradigm applied to posterior 
lumbar interbody fusions. Spine 11(6):601–606. 
https://drive.google.com/file/d/0B_Fo8tKvsaUyYlhleEphaU
tHQXc/view?usp=sharing  
Movement 
Disorder 
Society - 
Unified 
Parkinson's 
Disorder 
Rating 
System 
http://www.movementdisorders.org/MDS/Educa
tion/Rating-Scales.htm 
https://drive.google.com/file/d/0B_Fo8tKvsaUyRTdRSno4T
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FACT-MNG: tumor site specific web-based 
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