i. Overview of The UNC Health Registry/Cancer Survivorship Cohort
Contents
1. 7 23 2012 w Kisf Kathryn Alln Baseline Questionnaire Scheduled f MANMOHAN LAKHANI Tracking Status 10 41 2012 at Spm Andrew Hjelt 41647322 RETURN MANI 10 18 2012 9 24 2012 Andrew Hje Events Definition GU Prostate Ancillary Studies pere ng eB E RETURN ANDREW HJELT 10 29 2012 7 23 2012 Andrew Hje Release Notes Hist Baseline Questionnaire Scheduled 41 08 2012 at 200 PM Luis Serpa 41876681 RETURN JANEDOE 11 7 2012 11 6 2012 Luis Serpa Baseline Questionnaire Scheduled 11 08 2012 at 3 05 PM Luis Serpa 8747776 RETURN JOHN DOE 117 2012 11 6 2012 Luis Serpa Baseline Questionnaire Scheduled 11 27 2012 at 10 30 AM Nora 9242157 RETURN FRED ASTAIRE 3 26 2013 11 6 2012 Nora Christ Christopher Baseline Questionnaire Scheduled 01 10 2013 at 3 00 PM Caroline 41915752 NEW PENELOPE CRUZ 40712013 11 5 2012 Caroline He Hempel Queue lt first lt prev 4 next gt last gt gt Viewed By Baseline Questionnaire Need date 20576377 STEPHEN WOOD 10 09 2012 10 05 2012 Andrew Hje Baseline Questionnaire Need date 41764259 NEW STEVIE WONDER 10 18 2012 07 30 2012 Andrew Hje Figure 7 Interviewer Appointment Queue The Hot List indicates interviews scheduled for the current dav while the Queue lists individuals with an outstanding interview status 262. LIMS at the completion of each run These logs are linked to the individual samples histories and can be referred to in the future for a variety of reasons The results from analysis done within the facility are recorded in the LIMS database This includes agarose gel analysis with image optical density with wave graph real time PCR and bioanalyzer results Analysis reports are available to both the facility staff and project staff through the Web interface The current inventory of a given project is also available as areport This shows the entire project history in terms of material that was checked into the facility created by the facility and shipped from the facility No Personal Health Information PHI is maintained anywhere in the BSP systems When donor samples are checked into the facility the system allows for limiting the use of the samples based upon donor preferences i e allow genetic research destroy at project completion or restrict research to original project On a daily basis the Lineberger Data warehouse and Biospecimens Repository LDBR loads LIMS production data for reporting The data warehouse uses a read only account to connect to the LIMS database Storing LIMS data in the data warehouse allows HR CSC staff to create reports for their samples These reports include information about the samples that have been checked in the sample inventory and nucleic acid analysis data Future Tissue Procurement Facility
3. Layout For layout there are a series of tasks that are accomplished through drop and drag technology and dialogs within Mi Forms Designer Software Much of the layout is performed using the toolbar buttons These buttons allow for a wide range of data types and data collection objects to easily be included in the form alpha fields of various lengths numeric fields alphanumeric fields check box groups free form fields as well as a variety of specialized fields such as social security number and a wealth of date and time fields The form designer can also include images to further enhance the look of the form being created It is also very easy to order group and align objects to give the form a more professional look TIM Feces Diska fisis Report CL enka Report ae sab ox sP ambulance Report Business Rules A form may require simple business rules required fields cross field validation rules if gender is Male then question 5 must be greater than 8 or sophisticated consistency checking With Mi Forms Designer Software each of these types of rules can be built into the form during layout using the business rule and scripting language within the designer Data Path Technology and Communication The true power of electronic data capture comes in integrating captured data into existing enterprise applications The Mi Forms system was designed to support many modes of exporting data to external systems From Mi For
4. Registrv Cancer Survivorship Cohort and are tasked with responsibilities including collection processing and banking of HR CSC participant biospecimens A summarv of biospecimen collection and handling is provided below For detailed information on the HR CSC protocol for collection processing and storage of biospecimens blood and tissue please consult the UNC Health Registrv Cancer Survivorship Cohort Biospecimens Collection Processing and Storage Protocol Collection and Handling of Blood Samples Ator after enrollment participants who do not have portacaths ports in place are provided with a bag containing unique barcode labeled blood tubes This barcode label is linked to the participant and is used to track and annotate the blood specimen products Participants are instructed to provide the tubes to the UNC Hospital phlebotomist at the time of blood draw Once drawn the blood tubes are handled bv HR CSC staff who ensure proper logging including time of collection handling temporary storage and subsequent transport within 2 hours of collection to the Biospecimen Processing Facilitv BSP for further processing aliquoting and banking These events like those in enrollment are recorded bv HR CSC staff in the electronic Patient Tracking Svstem available on portable tablets in the clinic Once participant blood samples are transported to the UNC Biospecimen Process Facilitv BSP thev are logged into the BSP Laboratorv Info
5. Tumor Registrar Abstraction of Medical RecordS sesssesssesseesesseesstesseeseeestesesseesteeaeesteaneeseeateene 9 Augmentation of Medical Record Abstraction by HR CSC Staff eeseescessessesssessesssesteeseesteestesaeentesnsesseenseeee 9 Billing Code Initial Diagnosis for Cancer Specific Questionnaire Assignment smemmmnnn 10 Section 5 Cohort Patient Tracking Svstem msmrnzenannnznnananznzzznnananzanazanznzzzanenenznnazznznznzazza 11 Appendix System Spe cific Information smsernnennnnznnananznninananenznnazznznzizantnenzaznzznznznzanmnnnzazz 13 Enrollment Tablet Software Mi FOrms csessssssessesesssesssessesssesseeseecseesseeeseeneesneeseeestesecnteesteseeatesneesneeatenneesess 13 MI Forms Implementation with HR CSC Frequently Asked Questions smemmmmmenenenzennn 13 MI Forms Product DeSCriptiOn eseessesssecseeseesseseestecseesseestecseestesseesseeseesseeneeaseeseeseessecateeseeseesaeenteeneeaneeatesaeensees 13 Overview of Biospecimen Process Facility Laboratory Information Management System LIMS Quality Assurance Quality Control o eescesceessesesssessecsesseessesseesseesecstesseeseentesneesueesteeseensesseeeaeenteeneeseesteeaeenteeateeans 17 Biospecimen Process Facility Information Technologies LIMS csessessesssssesessesentestecsteseeeeentesneesees 19 Future Tissue Procurement Facility Laboratory Information Management System TPF LIMS 20 Medical Record Abstraction Electronic Regis
6. collection instruments and patient materials have been UNC Institutional Review Board approved ii HR CSC Data Collection Overview The HR CSC collects different pieces of information on participants at different phases of their enrollment Figure 1 provides a graphical representation of data collection events Kev highlights of the process include Prior to providing consent select demographic data elements from clinical scheduling systems are screened to determine eligibility This information is used to determine which patients should be approached for enrollment into the HR CSC Once approached in the clinic and informed of the cohort patients choose to provide informed consent Those who consent are then asked to confirm their contact information and answer a few brief questions Ideally a blood sample is drawn by a UNC Hospitals phlebotomist at the time of the enrollment visit Blood specimens are delivered by HR CSC staff to the UNC Biospecimen Process Facility BSP for processing and banking Blood plasma serum and DNA samples are prepared and banked IfaHR CCS participant undergoes surgery at UNC Hospitals leftover tumor tissue is banked by the UNC Lineberger Tumor Procurement Facility TPF The TPF processes surgical tissue specimens to snap frozen and formalin fixed and paraffin embedded FFPE tissue samples for research Following the enrollment visit a baseline questionnaire is administered that collects bot
7. relationships date time evaluation business rules etc on vour form On the Tablet PC verification and validation checks are performed as the user is collecting data in real time at the scene of data collection For digital pens verification and validation checks can be performed on the PC when the pen is docked Communicate Communicate and share vour data with existing enterprise svstems Data mav be exported from the Mi Forms Client to the centralized Mi Forms Server and then to other existing data repositories or exported directiv from the Mi Forms Client Recognized data text ink and form page background data mav be exported via a variety of formats csv xml ODBC MSJet Outlook variety of image formats etc Data exports may also be customized for greater flexibility in exporting your data to your existing data system ie HL7 SVG etc 14 In fact in each of the steps Mi Forms offers a host of options to provide vou with the flexibilitv to implement mobile data capture applications in the wav that best fits vour organization s needs Mi Forms Administrative Server The Mi Forms Server Version 7 0 allows the enterprise to control the flow of data manage accounts implement predefined workflow and deliver solution updates to the users Some of the key functions of the Mi Forms Server include Manage users passwords groups and privileges Manage form and solution revisions Forms based workflow Centralized
8. specific IRB certifications On a monthly basis the BSP lab managers generate check in reports from LIMS to verify the validity of sample collection and drop off dates In the LIMS project setup there is an option to send check in reports to study staff and lab managers on a weekly or daily basis There is a scheduled task that runs daily and emails the report to registered users This helps the study staff and lab validate what samples were sent and received each week The LIMS maintains an audit trail for each sample processed in the system Each audit record contains the technicians name and a date and timestamp The audit trail tracks everything that is done to the sample from the time it was checked into the system to when it was discarded or shipped to another facility There are audits for sample check in storage assignment extractions open and closing of protocols discards plan changes etc The LIMS uses several different types of input fields on the interface depending on the type of data being entered For numeric values such as volume and concentration the LIMS displays an input field that allows the user to select a number from an ordered list There are up and down arrows next to the data field for stepping through the values in the sequence The LIMS uses checkboxes for yes and no fields For example to mark a sample as discarded the user can check the discard box Dropdown boxes are used to select values like units container t
9. the lab receive 2D bar code labels that allow us to follow any sample s progress through the specific procedures indicated by the appropriate study protocol Samples that enter the lab are given a BSP ID number further protecting a study subject s rights These labels also contain a human readable portion and additional study encoded ID information The Biospecimen Processing Facility LIMS is Oracle based and maintained by the School of Public Health with security and backup The user interface developed and maintained by the School of Medicine is implemented as a Java thick client with limited read only WEB access provided to principle investigators and their staff The thick client tracks creation storage movement and discarding of containers vials and plates and the specifics of container contents material type volume concentration technician comments etc and is accessed only by BSP Facility staff All containers have a study context BSP staff has access to all studies but only specific PI staff as setup within the system can access information associated with their project via the WEB client LIMS users are required to login using their user id and password The passwords must be at least 8 characters and must contain a number and a special character etc The LIMS will not allow users to re use their last two passwords Each user is assigned a role which defines what features are available to them In addition to rol
10. to implement billing code based initial diagnosis a rule based algorithm was developed to assign questionnaires based on ICD 9 billing codes around the time of enrollment Source data originates from UNC Hospitals billing system and is exported to the Lineberger Data Warehouse and Biospecimen Repository LDBR Reports contain medical record number MRN corresponding to each subject the patient s date of visit and ICD 9 code This data is used in conjunction with the participant s date of HR CSC consent to select the billing records corresponding to the visit closest to the date of consent this is often but not always a visit on the subject s date of consent Billing codes from the selected date for each patient are matched against a questionnaire mapping table The mapping table identifies specific ICD 9 codes and their corresponding questionnaire Questionnaire assignments are displayed to interviewers in the Patient Tracking System so that the appropriate forms are selected during the time of interview 10 Section 5 Cohort Patient Tracking System Managing a large cohort is a significant logistical undertaking Ensuring a proscribed sequence of participation events requires operational systems that routinely record subject status accurately so that the next event can be ascertained and future workloads be determined Subjects enrolled in the HR CSC can take a variety of trajectories through study events depending on date of
11. 21 Participant Tracking Svstem The Sheps Integrated Research Svstem SIRS is a secure enterprise database and programming framework specificallv designed to meet the needs of health research projects at the Cecil G Sheps Center at UNC Chapel Hill Sheps SIRS provides reusable modules for data collection management and tracking for a diverse set of studies registries and research coordinating units SIRS is specificallv designed to provide a framework for programming that simplifies common programming tasks and allows customization while meeting applicable securitv requirements The SIRS framework is completely web based and open source utilizing MySQL Apache JavaScript and PHP The Sheps Integrated Research System offers many advantages to investigators Security Data management expertise Input and feedback from experienced SIRS programmers e Abilitv to incorporate designs from previous studies Continuity within projects but across projects over time Faster into the field capability Lower cost Availability of common components with tested and verified code e Thorough data auditing All system login procedures and data submissions e g from study staff or survey respondents through the Internet are encrypted via the Secure Sockets Layer SSL protocol to a secure central database at the Sheps Center User level permissions are based on user roles and are defined within the project system to lim
12. Laboratory Information Management System TPF LIMS Development of the future TPF LIMS System will be based on the BSP LIMS system and will be similar in scope development and implementation The Future TPF LIMS system will store information on collected tissue pathology status sample processing protocols and methods and banking and inventory information Medical Record Abstraction Electronic Registry System Software ERS Electronic Registry System ERS is a proprietary Cancer Registry software tool for collecting and storing medical record data The software standard data set required by the Commission on Cancer CoC and meets the requirements of the North American Association of Central Cancer Registries NAACCR The UNC Cancer Registry s Certified Tumor Registrars use ERS as a data collection tool for manual electronic medical records abstraction required by state law Approximately 80 of the hospitals in North Carolina use ERS The ERS software tool for the UNC Cancer Registry is maintained and hosted by ERS and delivered as a virtualized desktop It is accessed via website and requires entry of credentials The UNC Health Registry Cancer Survivorship Cohort HR CRC purchased the ERS software tool to facilitate transfer of UNC Cancer Registry data directly to HR CRC The UNC HR CRC ERS will be managed by the Lineberger Data Warehouse and HR CSC IT 20 team and ERS programming support group in conjunction with ISD to assur
13. UNC HEALTH REGISTRY CANCER SURVIVORSHIP COHORT Data Source Documentation 8 28 2013 in UNC Iil LINEBERGER COMPREHENSIVE CANCER CENTER N C CANCER HOSPITAL UNC Health Registrv Data Source Documentation Table of Contents i Overview of The UNC Health Registry Cancer Survivorship Cohort HR CSC 2 ii HR CSC Data Collection Overview iii ir i nna 3 Section 1 Cohort Eligibility and Enrollment ssssssssssssusunsununsnnunnununnnnunnnnunnnnannnnunnnnnnunnnnnnnnnannnnnnna 5 Section 2 Biospecimens ie ii a nna 6 OVEFVIEW i ira aq a a a a a 6 Collection and Handling of Blood Samples smmmmememenennzaninnzznnznmennzznnznzznnnzzznnznznzzznzzzazanza tenna rn4ate4asrnmanenanznzzzn 6 Collection and Handling of TISSUE anii aaia ianari iain aiaiai 6 Section 3 Questionnaires cciciisisntscecseciscscscecsssesverectsccssaesccvseensssenscitecssuastivenssdtesnassetsiranesdescessstecceraetaces 7 VOT VI CW i i B A A cay 7 Baseline Interview iii senior EE AAE aE kw fdtevaces usu giai 7 General Questionnaire sisina iiiad iiaii a ew 7 Cancer Specific Questionnaires oo esseestesseecstesseesteestesseesseeseesseestecneeseessecneesseestesseesseesseeaeesieenteaneeseesteeneeseeateeaeensend 8 Annual Follow up Intervie Wissmann i e ia a a a 8 Section 4 Medical Records Abstractionm smsmrrunnnzazanananananananananenenenanereranananananannananananannznznznzz 9 VET VI CW iii i a A E a G A nesndo anv aaeatee eae 9 Hospital
14. al s Tumor Registrv abstracts information on diagnosis and first course of treatment from the medical records for all patients diagnosed and or treated at UNC Hospitals Medical records are examined and data abstracted from the medical record and manuallv entered into an electronic registry system by certified tumor registrars CTRs Categories of abstracted medical record data include tumor diagnosis and staging information biomarkers tumor markers and treatment information Please consult the HR CSC data dictionary for more specific detail on abstracted fields Completion of abstraction generally occurs between six to twelve months after a patients initial diagnosis in order to capture full information on the first course of treatment The UNC Hospital Tumor Registrar utilizes a software product called ERS Electronic Registry Systems Cincinnati OH to collect medical records data Following the entry ofa patient s initial diagnosis ERS software tailors the abstraction fields in a cancer specific manner thus improving data quality Furthermore as diagnostic tumor staging and course of treatment information coding are updated nationally the ERS is updated automatically Augmentation of Medical Record Abstraction by HR CSC Staff The UNC HR CSC purchased ERS which affords the electronic export of data from the UNC Hospital Tumor Registry to the HR CSC ERS The ERS also has an additional feature known as free fields that can be custo
15. and completion status Note Log Address1 000 NOWHERE WAY Home 000 000 0000 Timestamp 7 24 2012 8 48 07 AM Address2 Phone City HAUNT Work Phone State North Carolina Cell Phone 111 111 1111 Zip 00000 Email Best HomePhone Contact Edit Demographics Date of Contact 07 08 3 20 013 d i Health Registry Time of Contact 06 29 PM Contact Reason Select phone call reason 08 09 2012 08 09 2012 status Definitions Edit Appointment Time 60 Baseline Questionnaire Scheduled Kathryn Allman 202 GI Gastric Scheduled Kathryn Allman ethod of Contact Select Method of Contact x Sticky Note kfisf Show Final Tasks Call Comments Figure 4 Patient Contact Information and Call Log 24 The participant event status page Figure 5 provides a brief summarv of kev studv events Vatient Listing interview Appointments Backlog Calendar Task Explorer fracking Status Events Definition Ancillarv Studies telease Notes 202 GI Gastric Scheduled Status ID Tracking Consent Informed Consent HIPAA Demographics Video Parking Voucher Consent Checkback Blood Draw Checkback ICD 9 Port Status Blood Draw Barcode Link Blood Draw Red Tube Blood Draw Lavender Tube Baseline Interview Thank Vou Letter First Contact Date Last Contact Date of Consent Note Log Timestamp 6692 Consented Obtained Saved Saved Saved Paper Form Only Saved Needed Comple
16. bility to see both tree and forest views 3 Home 41742446 GHOST CASPER Select Site Filter v D Name MRN Q Scheduling Blood Work Alt Contact Ref Phys ICD 9 Ancillary Studies Paten sting Identification Informed Consent HIPAA Interview tments Aw Patient Name CASPER GHOST Filename 210048827 pcf EEI Filename 1626058547 paf EEI Backlog MRN 41742446 Timestamp 7 24 2012 8 50 49 AM Timestamp 7 24 2012 8 51 29 AM ae Calendar CDART ID 00000245874260 rene si Demographics eigena Status ID 6692 FirstName CASPER Ethnicity No Events Definition Tracking Consented Esi Middle Initial Hispanic Latino Ancillary Studies Return New NEW Last Name GHOST Marital Status Single never married A Education Level Post e or TA Consent Obtained Suffix ihre rary ale Video Paper Form Only Maiden Racet White Port Status N Date of Birth 07 16 1964 Bes er Blood Draw Check Back Gender Female Reno Baseline Interview Scheduled Primary English La Race 2 Other Thank You Letter ngage ee First Contact 07 23 2012 Work for pay Yes mori Last MiForms 07 23 2012 Hours of work 40 or more hi per week Consenter Andrew Hjelt Date of Consent 07 23 2012 Contact Info Version 1 1 Figure 3 Patient Summary Page Contains contact and demographic information and links to Informed Consent an HIPAA Documents The patient contact information and call log section Figure 4 provides a convenient space to record contact events
17. btained dailv from the UNC Hospitals appointment scheduling svstems The HR CSC specific dailv clinic schedule report is populated with a list of individuals who determined to be eligible based on date of birth and residence These dailv schedule reports are used bv the HR CSC recruiters to identifv patients in the clinic who mav be approached for enrollment in the HR CSC Approached patients are shown a brief consent video This video summarizes the purpose of the HR CSC and explains what is involved in participation HR CSC recruiters are available for questions that mav arise After viewing the video patients who desire to participate in the HR CSC provide signatures electronicallv on both the HIPAA and the informed consent Following consent participants are asked to confirm their contact information and that of their referring phvsician as well as provide basic demographics information All data and events of HR CSC participation are recorded electronically on password protected tablets Portable tablets used in the clinic for enrollment are connected to a secure wireless network with data sent to a database and fileserver over an encrypted network connection Section 2 Biospecimens Overview As part of consent participants agree to blood collection and banking of leftover tumor tissue should thev have surgerv at UNC Hospitals The Biospecimen Processing BSP and Tissue Procurement TPF Facilities are partners of the UNC Health
18. collection is recorded as completed and the time of blood draw and transport to the blood processing laboratory is recorded in the enrollment tracking system More information on blood sample collection and transport are available in the Biospecimens Collection Processing and Storage Protocol Following a patient s consent they become eligible to receive the computer assisted telephone administered baseline general and cancer specific questionnaires At the time of enrollment the telephone interview is scheduled using the HR CSC tracking software As cancer specific billing codes are generated during visits to UNC Hospitals the tracking system automatically matches codes that trigger cancer specific questionnaires Study staff use the participant tracking system to load the interview appointment schedule Each entry in the schedule links to the corresponding participant profile which displays contact information and a contact record form to the interviewer for the purposes of annotation Interviewers then open the computer assisted telephone interview system visualized on a second computer screen to perform the interview Details on the specific use of the study tracking system are detailed in the Interviewer Protocol Document 11 The Patient Tracking Svstem has a number of kev features For a summarv of each participant the svstem provides a profile page that allows a user to see the status of kev participation events at a glance for a parti
19. conduct unit and integration testing During unit tests developers verifv that the newlv added code functions properlv and solves reported bugs Integration testing is used to make sure the changes don t break existing functionalitv We have a series of general test cases that we run before releasing a new version The steps for deploving a new version are documented and stored in our group s internal directorv We are implementing code reviews as a part of the deplovment process Each release is tagged with a version number The code versioning svstem CVS maintains a historv of the code versions and a change historv for each file in the repositorv From Eclipse Vou can view the change historv for a given file and compare it to another version We document the changes in each release on our group wiki 17 When new studies are added to LIMS the BSP lab managers meet with the principal investigator to discuss the sample processing workflow Then the BSP lab managers create protocols within the LIMS to standardize the procedures in each step of the workflow Additionallv each lab technician receives periodic training to learn the lab s standard operating procedures as well as to maintain certifications pertinent to the work in the lab i e blood borne pathogen HIPAA and CITI training The LIMS has the functionalitv to maintain a listing of the certifications and validitv dates for each user The LIMS also has the functionalitv to track project
20. cular participant Additionallv the interviewer dashboard provides a summarv of outstanding scheduled interviews across the cohort to facilitate HR CSC workflow Other features include participant lookup generation of patient materials e g thank vou letters newsletters and is an administrative interface for report generation The interface also provides staff with a wav to record and verifv a subject s vital status Screenshots of the interface are available in the Patient Tracking System appendix The participant tracking system is also used by HR CSC staff to track and record events for ancillary studies Each ancillary study has its own dashboard displaying enrollment summaries and status of key study events which may include interviews mailings and specimen processing In summary this system provides a unified interface for collecting information important for monitoring global level events participant specific status and ancillary studies 12 Appendix Svstem Specific Information Enrollment Tablet Software Mi Forms The HR CSC studv utilizes Mi Forms software Mi Corporation Durham NC This software runs on laptops with tablet stvlus capabilitv running Windows XP Ml Forms Implementation with HR CSC Frequently Asked Questions How is MICO Used MI CO products are used during the consent process Study staff approach patients in the clinic and seek a response regarding willingness to participate in the study An elec
21. data export including custom data exports from script Server side script code using same APIs and event model as client component e Open web services based communication over HTTP HTTPS that can be integrated with Mi Forms SDK built applications Centralized Management with Mi Forms Server e Data validations can be performed server side e Supports workflow via concept of queuing e Enables data and form sharing between individual users or groups e Forms can be routed based on data content e Decisions on routing can be made either automatically via script code or via user interaction at form finish time Using the Mi Forms Administrative Server you can create a predefined workflow pattern The data collected can move automatically to the next user or group Mi Forms Server Supported Technologies e Windows Server 2003 2008 R2 e SQL for data storage SQL Express or SQL 2005 2012 e ASP Net under Net 3 5 15 Products Mi Forms Desienei The Mi Forms Designer is a robust product that enables vou to design custom forms for a varietv of applications The intuitive graphical interface of Mi Forms Designer Software allows vou to easilv build a form that is just right for vour organization The Mi Forms Designer has three kev components e WYSIWYG layout tool for form design e A business rule and scripting language for robust data verification e Extensive data path technology for communication to back end data bases and systems
22. e versioning comparability In addition to the required CoC data sets see Table 1 ERS makes available to the UNC HR CSC other data fields including those that can be customized to fit our specific needs The additional fields include expanded research and diagnostic fields clinical trial fields as well as user defined fields that can be created and maintained by the user The HR CRC staff will manually abstract these additional data fields see Table 2 from the electronic medical record to complement the data that is provided directly in ERS from the UNC Cancer Registry Coding manuals are online and maintained by the ERS software company ERS provides users with a very extensive reporting module for data analysis to compare treatment analysis survival incidence by site stage race etc Any data item in the software can be selected and used for reporting purposes The software contains a follow up module that allows the user to automatically schedule follow up lists and letters with patients ERS provides three days of initial on site training for new users as well as unlimited on line training A complete user manual is provided as well as a Video Library of training tutorials see online Resource list below The software is updated quarterly ERS notifies ISD or user via email that the software update and document detailing update changes is available and quarterly training webinars are provided that are awarded continuing education credits
23. enrollment specific cancer type and length of follow up see Figure 1 for general sequence of events Tracking progress through study participation events requires a system for logging the sequence and completion of participation events for each individual During clinic recruitment HR CSC staff utilizes a schedule report based on information from the clinic scheduling system This data is pre populated onto a tablet computer running the enrollment tracking software Mi Co Mi Forms Mi Corporation Durham NC to expedite the enrollment process When a patient is approached for enrollment the staff member is able to quickly look up patient information and complete the electronic consent and demographic questions Full information on enrollment procedures can be found in the UNC HR CSC Clinic Enrollment Protocol After consent is obtained blood is collected from the participant in the clinic Several data elements are recorded for each participant during this process The participant s blood draw eligibility is determined shortly after consent is given and is recorded within the enrollment software Before a blood draw event the recruitment staff member takes a preprinted unique barcode number and affixes one copy to each of two tubes one red one lavender for tracking purposes This number is then associated with the participant s unique HR CSC ID within the enrollment software After the phlebotomist collects the blood specimens the blood
24. es PI staff members are associated with projects Staff members can log into the WEB client to view reports for samples in their projects Each container created by the system is assigned a BSP identifier that is unique in effect this is the facility asset identifier for that container sample Each container is labeled with the BSP identifier project donor identifiers type of contained material volume concentration if applicable date of creation and current storage location Containers may be pre assigned to a protocol path that eventually leads to the departure of the containers from the facility but may also result in long term storage within the facility Through a query interface sets of containers may be identified pulled and be further processed within the facility or be shipped to other facilities An audit trail is maintained on containers and content This trail records such things as when and who drops off containers to the BSP when the container was created as it moves through processing in the BSP as directed by the studies protocols which technician created it when and where it was stored when and where it was pulled from etc The system will track materials that are transferred to other facilities or PI collaborators as well The LIMS has the capability of accepting processing logs generated by the Auto pure LS DNA extraction robot and the Multirole II aliquoting robot These logs can be 19 transferred to the
25. from the National Cancer Registrars Association NCRA ERS provides unlimited support to users for all registry and technical issues To be a CTR Certified Tumor Registrar one is required to have a minimum of a 2 year degree in a health related field and pass the national CTR test As of 2012 each registrar must be certified to perform abstraction There are internal edit checks within the software that come up if illogical information is entered such as female for prostate cancer zip code and county code matching errors as well as procedure and staging conflicts such as entering pathologic staging when the patient has had neoadjuvant therapy Required fields cannot be left blank Additionally about 10 of the cases are identified by the UNC Cancer Registrar and are re abstracted to check for accuracy A quality control protocol involving re abstraction of a proportion of records to monitor data quality of additional HR CSC abstracted data elements will be implemented Additionally both UNC Cancer Registry and UNC HR CSC manually abstracted medical records data elements will be compared with planned EMR extractions for additionally quality assessment Resources 1 ERS Website http www ers can com 2 FORDS manual for 2013 http www facs org cancer coc fords fords manual 2013 pdf 3 7th edition AJCC staging manual http www cancerstaging org products ajccproducts html ISBN 978 0 387 88440 0 must purchase for 65 see website
26. h general and cancer specific information on health history lifestyle patient reported outcomes and health care system interaction Abstracted medical record information collected by the UNC Hospital Tumor Registry to comply with state cancer reporting requirements is shared with the HR CSC Cancer diagnosis tumor characteristics and general treatment information are available through this resource For HR CSC participants HR CSC medical records abstractors augment the Hospital Tumor Registry data with specific details not collected by the Hospital Tumor Registry e g chemotherapy drug and dose Health Registrv Cancer Survivorship Cohort Data Collection Overview clinic scheduling system Baseline Tumor Tissue Medical Record Questionnaires Specimen Abstraction MRA ae i Includes data from UNC Hospital Administered j Cancer Registry and manual cene IEE ifie Tissue sample snap frozen g and paraffin embedded abstraction Annual Follow Up Questionnaires amp MRA Tracking FO E E System Flags patient record with study Post Consent after Initial Appointment status Figure 1 UNC HR CSC Stages of Data Collection Section 1 Cohort Eligibilitv and Enrollment The enrollment process begins with a list of eligible patients scheduled for appointments in cancer clinics at UNC Hospitals The cohort is open to individuals 18 vears or older who provide a North Carolina address Clinic schedule data is o
27. it each user s access to only those records they are authorized to see The central database for projects runs on a mirrored server system with automatic fail over features daily backups and transaction logs This system is physically located in a Tier II Data Center providing backup power sources climate control fire protection and 24x7 surveillance Audit logs are reviewed routinely to verify security measures are operational The servers are scanned weekly for vulnerabilities and are currently maintained at the highest level of vendor and CERT security recommendations Data are never shared outside the project unless authorized by the project leader User authentication is based on user passwords Password creation requirements are in place to guarantee strong passwords as defined by the CERT security recommendations The lead systems administrator is GIAC Security Essentials certified through May 2014 The UNC Sheps Center endeavors to preserve the privacy confidentiality and security of protected health information that may be part of health records or research datasets Protected Health Information PHI is handled according to appropriate Health Insurance Portability and Accountability Act of 1996 HIPAA Privacy and Security Regulations Sheps Center programmers and research staff who work with sensitive data are required to complete appropriate HIPAA training with periodic updates complete Sheps Center internal training comply w
28. ith the UNC IT Security Policies and agree to the provisions of 22 the Sheps Center s Rules of Behavior and Sanction Policv The Sheps Center strives to implement reasonable securitv controls guided bv FISMA HIPAA and OMB Circular A 130 Appendix III Participant Tracking Svstem Screenshots The participant tracking svstem is a web based application that provides real time information on cohort st