Clinical Research Support

PATS FAQs

Why do we have to record accruals in PATS?


The Cancer Consortium is subject to multiple regulatory and organizational requirements with regard to accrual reporting.  Examples include the NCI CCSG (Cancer Center Support Grant) “Core” grant and  NCI Clinical Trials Reporting Program (CTRP).  Requirements typically include defined data elements and timeframes for reporting.  PATS is designed to accommodate this reporting.
 

When do I need to record accruals in PATS?


The research subject accrual data must be entered into PATS within one business day after enrollment on a study.   It is imperative to enter the enrollment data in a timely manner so downstream systems that facilitate operations and reporting based on who is on study may operate in an optimal manner. Please refer to the Consortium's Clinical Trial Reporting Obligations policy for requirements: https://www.cancerconsortium.org/content/dam/consortium/Policies/13008S_Accrual_Data_Collection_Policy.pdf

Why do we have to record "date study services started" in PATS?


The Cancer Consortium is subject to multiple regulatory and organizational requirements with regard to accrual reporting.  Examples include the NCI CCSG (Cancer Center Support Grant) “Core” grant and NCI Clinical Trials Reporting Program (CTRP).  Requirements typically include defined data elements and timeframes for reporting. PATS is designed to accommodate this reporting.
 

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.  CRS 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 Investigator and Primary Study Coordinator asking for permission to add you as a contact. Once permission is obtained, access will be granted 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.  For multi-center trials, the coordinating site must enter externally enrolled subjects into PATS directly.  PATS can be accessed in your web browser directly by navigating to https://pats.fhcrc.org.
 

How do I enter enrollments for multi-site trials?


If a Consortium site is the coordinating center for a multi-site trial, the Consortium study team must enter externally enrolled subjects into PATS. The performance sites cannot have access to PATS.
 

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 on PI Name, Institution, Study #, 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 top of list when existing sorts won’t do this?


At present, there isn’t 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.
 

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@fredhutch.org to correct the error.
 

How do I edit the protocol title?


If you see an error in the title of a Protocol, send the details in an email to Clinical Research Support at CRScustomerservice@fredhutch.org. They will investigate and correct the error.
 

Is there a way to undelete a subject after you have clicked Submit Request on the Request Removal of Subject form?


If you accidentally send a request to delete a subject, or wish to ‘undo’ a subject registration, send an email to Clinical Research Support at CRScustomerservice@fredhutch.org.

What if the subject I’m trying to register doesn’t fit the categories in the Disease Site 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 Clinical Research Support at: CRScustomerservice@fredhutch.org.
 

  Disease

  Disease Site Selection

  Aplastic Anemia

  Other Hematopoietic

  HIV

  Non Cancer / Non Malignant

  Liposarcoma

  Soft Tissue

  Leiosarcoma

  Soft Tissue

  Herpes/HSV

  Non Cancer / Non Malignant

  Antigens of Tuberculosis

  Non Cancer / Non Malignant

  Donors

  Non Cancer / Non Malignant

  Colorectal – colon or rectum?

  In most cases, colon

 

Menu Search