 |
|
|
 |
|
|
|||||||||||
|
|||||||||||
|
|
| What is the “philosophy” of the PCCR project? | ||||||||||||||||
|
The PCCR is a community-driven project that was initiated by a group of experts in genetics, surgical pathology, epidemiology, nutrition, medical oncology, gastroenterology and computer science, working on pancreatic cancer. This community involved a panel of 21 experts representing Creighton University, Evanston Northwestern Healthcare, Johns Hopkins University, Mayo Clinic, New York Medical College, University of Nebraska Medical Center, University of Pittsburgh, University of Washington, and the NCI.
The Core Data set also includes the following administrative data elements:
|
||||||||||||||||
| How were the standardized forms developed? | ||||||||||||||||
|
The matter of standardization and categorization of the collected data has been taken very seriously from the inception of the PCCR. For this purpose, four committees (Pathology/Specimen, Epidemiology/ Instrument, Imaging Collection, and IRB) were organized from the group of 21 aforementioned experts. Questionnaires already in use at the participating institutions, as well as established forms for the socio-demographic, environmental, clinical and family history data of individuals and family members with a history of pancreatic cancer, were analyzed and agreed upon by these groups. Existing standards, such as Health Level 7 (HL7), International Classification of Diseases (ICD-9), Systematized Nomenclature of Medicine (SNOMED), Common Data Elements (CDE), etc., were also utilized in the development of the forms.
Questionnaires well recognized in the cancer research community, such as the FACT-hepatobiliary /pancreas symptom index version 2.0 and the NCI Quick Food Scan Percent Fat Screener questionnaires are also implemented. When creating the physical activity page, the American Cancer Society’s (ACS) examples of moderate versus vigorous physical activity guidelines for cancer prevention (Byers, CA 2002 52:2) were used. |
||||||||||||||||
| Where is the data we enter physically located? | ||||||||||||||||
|
The Web-based PCCR is housed in the University of Nebraska Medical Center (UNMC), Eppley Cancer Center Bioinformatics Shared Resource facility under the leadership of Dr. Simon Sherman. The project takes advantage of an extensive infrastructure of hardware, programming, software libraries, and data management routines, as well as the intellectual resources of the UNMC Bioinformatics Shared Resource facility.
|
||||||||||||||||
| Will the system be functioning all the time once in place? | ||||||||||||||||
|
Yes, registered users will have around-the-clock access to the system from anywhere in the world. Technically, the system will be available 24 hours a day, 7 days a week with the exception of 2 hours of downtime a week for maintenance.
|
||||||||||||||||
| What happens if the system fails? | ||||||||||||||||
|
There are four situations when the system could be inaccessible:
We constantly mirror all of the data to another hard drive as well as backup all of the data nightly. In the worst scenario, only current changes on the form you have been working with, could be lost if the system fails. Everything else is saved in the database, backed up and could be retrieved after the problem is rectified. |
||||||||||||||||
| Can we edit the template of information entry latter on? | ||||||||||||||||
|
If there is a need to change a form or add additional information, it can be done. Some changes can be made very quickly and some could take several weeks: it all depends on the difficulty of the change. In any case, none of the changes have to be made at the user site: everything is completed on the server at UNMC.
|
||||||||||||||||
| Should we enter only patients with pancreatic cancer? | ||||||||||||||||
|
No, The PCCR allows clinicians and researchers to better organize and analyze information in clinical, epidemiological, nutritional, pharmaceutical, and genetic studies of familial and/or sporadic cases of pancreatic cancer as well as, individuals at high risk of developing this disease (unaffected individuals).
|
||||||||||||||||
| We have several patients on our local pancreas cancer database - do we load these up? | ||||||||||||||||
|
Yes, if you already know the list of fields you would like to export, a program developed in the UNMC Bioinformatics laboratory could do it. (Perhaps, some adjustments will be needed to take care on specific fields in your database). We are currently helping Creighton University to convert their MS Access database into the PCCR.
|
||||||||||||||||
| I have had access to the demonstration version of the PCCR. Will my ID and password continue to work in the production version of PCCR or would I need to be registered again? | ||||||||||||||||
|
Initially potential users and their center participants’ are assigned access only to the Demonstration version of the PCCR. If you decide to become a participating center you will need to define your center name and identify users for this site and their level of access to the registry. You will need to have all of the research activities and consent forms approved by your Institutional Review Board. The PCCR operates under an IRB-approved protocol for data collection, storage, and sharing at the production Web-site http://pccr.unmc.edu/. Written consent from participants for research will need to be obtained.
|
||||||||||||||||
| Please confirm that only our center can access our own data. | ||||||||||||||||
|
Through secure log-on and password-protection, clinicians and researchers at participating centers will be able to retrieve only the patient data entered from its site. There will be five types of users of the PCCR (patient, coordinator, clinician, center manager, and PCCR systems coordinator) defined below. Each will be assigned an appropriate level of access to clinical data and will have a particular type of authority. All patient identifiers defined by HIPAA standards will be encrypted at the registry level such that no one, including the PCCR System Coordinator at UNMC who tracks the accuracy of all site data, can identify an individual patient. The registry will assign a site, family and individual ID for each patient entry. The users will receive a password according to their particular type of authority. A user is able to access only the particular resource that has been granted to the user.
|
||||||||||||||||
| If only the individual groups can access their own data, how do we get an overview to see how the joint databases might be used for collaborative projects? | ||||||||||||||||
|
Levels of access for the investigators and collaborators depend on the agreement between the collaborators. Each center can decide that its data is not accessible for anyone else or otherwise; all data accessible to all collaborators, or only part of the data should be accessible and everything else is secured. In either case, you need to make this decision.
An overview of the joint databases can be done in two ways. The first way is to use simple queries (Oracle reports) of the registry. Several tools are already in place to produce simple reports from the registry. The list of these tools will be significantly upgraded to the end of this year. Right now, in principle, we can generate a number of simple reports at the requests of users. The second way is to use technology of data warehousing (DW). In order to do this, data collected in the PCCR will be transferred into the data warehouse. A data warehouse is a separate, read-only database, designed specifically for mining large volumes of PC-related data for analysis and decision-making purposes. The DW is not a static data repository; it provides easy access to large amounts of data by means of a dynamic querying system. Once the data is loaded into the DW, users have a chance to see what data is available to them. The purpose of data mining is to discover hidden or unexpected relationships in the data that may direct researchers to interesting trends and leads that can be followed up with other models of analyses. The pilot DW for the PCCR data is completed and we are currently working on implementing the production version of the DW. |
||||||||||||||||
| What types of security measures are in place to protect unauthorized users from accessing the registry? | ||||||||||||||||
|
The application is installed on the Oracle9i Application Server, the database is kept on the Oracle 9i database server. Both of the servers are protected by the UNMC firewall and located in a physically secured room.
Security issues are addressed using recommendations of the Computer-based Patient Record Institute (CPRI) and the electronic information security standards mandated by the Federal Health Insurance Portability and Accountability Act (HIPAA). According to the CPRI, a complete security solution that maximizes the benefits of networked data communications must contain the following elements: User authentication, Access control, Encryption, Physical protection, and Management.
|
||||||||||||||||
| On a day-to-day basis is there funding to help with data input as we already have three/four separate databases that we input into? | ||||||||||||||||
|
Currently there is no funding for data entry. For the PCCR, the majority of the data is to be obtained from and submitted by the subject and the medical data required should be collected and submitted by the clinicians involved in the subject’s care.
We believe that PCCR will help its users to apply for federal funding. There is no fee for use of the PCCR. However, if and when you submit a new grant application with provision of the use of the PCCR, it would be reasonable to secure a portion of funding for data entry and support maintenance of the PCCR. Dr. Sherman at UNMC would be glad to help you with writing the bioinformatics portion of your grant applications. |
||||||||||||||||
| Once installed into the PCCR, is there a fee for its continuation? | ||||||||||||||||
|
There will be no fee for continuation of the PCCR. Again, if and when you submit a new grant application with provision of the use of the PCCR, funding support for the PCCR should be secured in the grant application. We would be glad to help you with writing the bioinformatics portion of a grant.
|
||||||||||||||||
| Could you provide information about HIPAA, IRB, and sharing data? | ||||||||||||||||
|
The PCCR operates under an IRB-approved protocol for data collection, storage, and sharing at UNMC. Written consent from participants for research will need to be obtained. Each participating center will need to have all of the research activities and consent forms approved by their own Institutional Review Boards.
As a participating center you will have access to templates of the wording that is in use for centers participating in the Pancreatic Cancer Collaborative Registry (PCCR) that may be useful for an IRB application and patient informed consent form. These templates address the HIPAA, IRB and data sharing concerns, of course individual centers applications for the PCCR will have to be appropriately adapted. |
||||||||||||||||
| Will the Certificate of Confidentiality mentioned in the Informed consent applies to us? | ||||||||||||||||
|
UNMC holds a multi-site ‘Certificate of Confidentiality’ (COC) from the National Cancer Institute on behalf of the Secretary of the Department of Health and Human Services to prevent a court of law from being able to subpoena Registry records. The COC will apply to all institutions participating in this Registry.
A Certificate of Confidentiality will not be issued to an applicant conducting research involving human subjects unless the project has IRB approval. The approving IRB must be in compliance with applicable Federal requirements. Therefore we will need your IRB approval letter in order to add your center to the COC. We will also need documentation of your IRB qualifications. The University of Nebraska Medical Center OHRP Assurance Number is FWA00002939 and is active 7/02-7/05. As the lead site of this multi-site project, we will maintain a copy of the OHRP assurance number for the all of the reviewing IRB's, which we have to make available to the NIH upon request. For additional information on OHRP and IRB assurances, see http://ohrp.osophs.dhhs.gov/irbasur.htm. |
||||||||||||||||
| Is there a plan for detailed attention to training and formal definitions for all personnel at all sites? | ||||||||||||||||
|
We appreciate and recognize the challenges of bringing this project to life. Many of these challenges (structuring and encoding information; developing interfaces to a variety of research and clinical sites that integrate with their workflow; formulating standard criteria statements for IRB contents detailing the use of Web-based tools; standardizing descriptions regarding human subjects’ rights of privacy and informed consent issues under the new details of the federal HIPAA regulations; assisting IRB’s in their review of protocols using online technology; etc.) have been successfully overcome. We realize, however, that the training of personnel at all participating sites is one of the most challenging parts of the project and is a key to its success. For this purpose, manuals for the PCCR Clinician/Coordinator and Center Administrator have been developed. These manuals provide detailed instructions for logging on to the PCCR system and step-by-step instructions for completing the forms. It also clarifies some of the terminology used. Moreover, the PCCR coordinator is available to provide training sessions to orient participating centers’ personnel to the registry with one-on-one sessions.
|
||||||||||||||||
| How would you sort out authorship for future 'joint' publications? | ||||||||||||||||
|
The Principal Investigator will discuss authorship with each center at the time of the initiation of a collaborative study. Suggested guidelines include:
The sequence of co-authorship on each abstract/manuscript will be determined by the Principal Investigator. A formed subcommittee made up of uninvolved members of the advisory and prioritization committee will arbitrate any disagreements. If the PCCR will be used in the study, proper acknowledgement of this should be made. |
||||||||||||||||
| What are the PCCR technical requirements? | ||||||||||||||||
|
Any major web browser on a PC, Mac or tablet with:
|
||||||||||||||||
|
|
TOP | |||||||||||||||