What is PATS?
The Protocol Accrual Tracking System (PATS) is a Web-based application for tracking and summary reporting of accruals for Cancer Consortium studies as required by the NCI Cancer Center Support Grant. PATS is designed to facilitate this reporting by collecting data from studies at partner institutions on an ongoing basis. Consortium investigators and staff will have the ability to report accruals, edit existing data, and view online accrual reports for the specific studies that they are authorized to see.
How will PATS be used?
PATS will be used to report summary protocol accrual information and totals to the NCI, as required by the Cancer Center Support Grant. Information will only be reported to the NCI in aggregate, summary form. Only the principal investigator (PI) and designated study staff will have access to individual subject data.
Who has access to PATS?
PATS access will be given to study personnel who are authorized by the principal investigators or study coordinators to update accrual information. This is controlled through the Protocol/IRO system, and is based on individuals with specific roles (e.g., study coordinator, research nurse, PI, co-PI, study contact) as designated in IRO application documents (FHCRC) or specifically identified by the principal investigator. The PI and/or study coordinator may at any time request that access be granted or revoked for a given user. No user will be able to see any details for studies that they are not authorized to update. On a periodic basis, the PI and/or study coordinator will be asked to review the list of users with update access and may add or remove individuals as appropriate.
What data does PATS contain?
PATS is used to track ethnicity, race, gender, year of birth, site of disease, date of enrollment, and date consent was signed for every participant enrolled in studies taking place in the Cancer Consortium. We need to track individual study subject-level data since July 1, 2002 (the beginning of the Cancer Center Support Grant reporting period). Since the reporting totals are generated using calculations on multiple criteria, the individual level data is necessary in order to ensure that the totals are calculated identically across studies and programs.
How secure is PATS?
Access to the PATS system is controlled through a secure site and users will only be able to view, add or edit subject information for studies that they are authorized to update. The system itself is maintained on a secure server in a locked room by dedicated, professional staff who perform routine maintenance and regular backups. As with all systems containing potentially sensitive data, access is restricted to users with verifiable need and is disabled upon termination of employment or a pre-determined period of non-use. All access and updates are logged. Specific gatekeeping, technical security and confidentiality measures are outlined in detail in the approved IRB application for Protocol 1833.
When does information need to be entered into PATS?
Accrual data should be entered into PATS on a regular, ongoing basis (within seven days of subject's enrollment on a study). The trigger event for entry into PATS is the point of subject enrollment onto a study, which assumes all of the following have occurred:
- IRB and other required approvals have been obtained (e.g., study contracts, radiation safety)
- Informed consent has been obtained and documented
- Eligibility for protocol has been determined
- Patient is enrolled on the study
Will PATS replace any current subject registration processes?
No. PATS should be used for documentation of subject registration only - not actual registration. Subjects should continue to be registered using the normal processes established for a given study.
Which studies need to report accrual?
Studies subject to the Consortium Protocol Review Requirements (PRR) criteria are required to report their human subject accrual. In general, this will include all interventional cancer research studies initiated by Consortium member principal investigators based at the UW, FHCRC, or Seattle Children's as well as PSOC studies. All trials are included, regardless of funding source (NIH, industry, institutional, or unfunded). A trial is considered to be implemented by a Consortium member if the member is listed as the PI of the study. Types of studies included are:
- Treatment trials
- Prevention trials that include an intervention (such as drug, diet, exercise)
- Quality of life trials that include an intervention.
Whom should I contact with additional questions?
How do you access PATS?
PATS is accessed similarly to the FYI system, through the CORE's (Clinical Oncology Research Entrance) secure website.
To enter CORE, you need a userID and a password. If you already have access to FYI, access to PATS can be added to your existing account without a new userID and password. To request access to the CORE, click the link under 'New Users'.
Once you have logged into the CORE portal site, you will be presented with a menu listing of applications you are authorized to access. PATS is started by clicking the Cancer Consortium link.
How does the Request Access process work?
The Request Access link displays a form requiring entry of your name and contact information, your supervisor's name and contact information, and the institution and department in which you work. This request will be sent by PATS to Clinical Research Support. Clinical Research Support will check to see if you are listed as a contact for the study. If you are not a listed contact, they will send an email to the principal investigator and study coordinator (if applicable) asking for permission to add you as a contact. You will be copied on this email. Permission will be considered granted if the investigator or coordinator does not respond within 48 hours.
Why do you need to know who my supervisor is?
PATS keeps track of who recorded each entry in the system. If there is ever a need to contact someone regarding an entry or update, having the contact information of the user and the user's supervisor will help efficiently locate someone with information on the study.
Who will be given access to PATS?
PATS access will be given to study coordinators and personnel who are authorized by principal investigators or study coordinators to update accrual information.
I work at UW / Children's / SCCA / PSOC. How do I get access to the CORE site?
Each institution has a different way of tracking studies, so how does PATS work?
PATS is fed information from the Clinical Research Support database. This database contains all of the study and staff information for the Consortium. Fred Hutchinson and PSOC study data resides in this database. UW and Children's data is updated on a regular basis into the database. PATS records accrual information in a separate database that is used for generating accrual reports.
Can I search for protocols from any PI?
PATS offers "read" access of study titles, principal investigators, and institutions to all authorized users. This allows for the browsing of all the protocols within the Consortium.
How do I find a protocol when it is not listed in "My Protocols?"
If the protocol you need is not listed on your My Protocols screen, use the "Search" feature to find it. You can search by investigator name, institution, and title. If the protocol does not appear on your My Protocols screen, you will need to request access to the protocol.
Is there a way to bring a specific protocol to the top of the list when existing sorts won't do this?
At present, there is not a way to select a specific protocol to be at the top of a list other than by the available numeric and alphabetic column sorts. This is a feature that is being investigated for future addition to PATS.
What do I do if I can't log into PATS but need to register an accrual?
How do I edit Contact Person information?
To see who is authorized to access the protocols on your My Protocols list, click the View/Edit Subjects link to display the study details page. Click the View Auth Users link to display the users authorized to access the protocol. You can request the removal of a user by clicking the Request Removal link. If there is an error in the spelling of a Contact Person's name, contact Clinical Research Support at CRScustomerservice@fhcrc.org.
How do I edit the protocol title?
Is there a way to undelete a subject after you have clicked Submit Request on the Request Removal of Subject form?
What if the subject I'm trying to register doesn't fit the categories in the disease site drop-down menu?
The Disease Site list was developed by NCI for reporting purposes. Below is a list of cancers and diseases not specifically listed and the correct Disease Site listing to select. If you are not sure which site to select, contact Data Management at: email@example.com.
- Aplastic Anemai - Other Hematopoietic
- HIV - Non-Cancer/Non-Malignant
- Liposarcoma - Soft Tissue
- Leiosarcoma - Soft Tissue
- Herpes HSV - Non-Cancer/Non-Malignant
- Stem cells transplanted with solid organ - Non-Cancer/Non-Malignant
- Kidney transplant patient diabetic - Non-Cancer/Non-Malignant
- Antigens of Tuberculosis - Non-Cancer/Non-MalignantDonors - Non-Cancer/Non-Malignant
- Colorectal - In most cases, colon