Clinical Research Collaboration Agreement

Use this PCORnet-approved agreement to speed the contracting process for PCORI-funded studies. This pre-negotiated template agreement can serve as a starting point for prime and site investigator negotiations. The result is time-savings in the contracting process for PCORI-funded studies since sites are already negotiated in advance.

Access the collaboration agreement here.

GPC Tumor Table Transformation and Linkage

The PCORnet tumor table contains data from hospital tumor registries that are formatted according to standards developed by the North American Association of Certified Cancer Registrars (NAACCR). All hospitals that are accredited by the American College of Surgeons Commission on Cancer employ trained registrars to abstract medical record data according to these specifications. Researchers can use this resource transform their own tumor registries.

Access the GPC Tumor Table Transformation and Linkage

Structured fields for demographic, clinical, and treatment observations are included, and the data are considered to be high quality. GPC tumor table documentation includes specifications for data formats, quality checks, and relationships with other CDM tables. This standardization allows linkages between NAACCR data and the other CDM tables. It also allows queries of the NAACCR data to be quickly deployed across the network.

GPC sites have already transformed their hospital tumor registry data into the PCORnet TUMOR table format. Table specifications can be found here. A sample ETL code and workflow are attached for references.

To assess the quality and quantity of tumor registry data found in the TUMOR table at GPC sites, a quality control script was created to be run against the newly created TUMOR tables. QC reports are being used for quality evaluation.

SMART IRB and IREx List

This form gives investigators and project teams a consolidated view of which sites participating in PCORnet maintain an IRB. It also provides the site Federal Wide Assurance (FWA) number and notates which sites have signed the SMART IRB reliance agreement and registered in the IRB Reliance Exchange (IREx) platform. This site list is updated regularly and eliminates the need for investigators and project teams to search for key information in several different places.

Access the SMART IRB and IREx List here.

Data Study Flow Resources – Basic

This diagram shows a basic data flow in a study powered by PCORnet® and is intended for sites to include in their IRB application. Using this document, project teams can ensure consistency in IRB applications and speed IRB submission by providing a template for sites to quickly fill in the blanks based on data flow in their study.

Access the Basic Data Study Flow Diagram.

Data Study Flow Resources – Complex

This diagram shows a complex data flow in a study powered by PCORnet® and is intended for sites to include in their IRB application. Using this document, project teams can ensure consistency in IRB applications and speed IRB submission by providing a template for sites to quickly fill in the blanks based on data flow in their study.

Access the Complex Data Study Flow Diagram.

Data Sharing Agreement

The Data Sharing Agreement (DSA) is an approved PCORnet template for use by research institutions to speed prep-to-research queries. The DSA defines the standard terms to which the Coordinating Center for PCORnet® will adhere when data are sent from the Network Partners to the Coordinating Center. The DSA also contains a template showing the flow of data through the queries.

Access the Data Sharing Agreement here.

Research Ready Training Resources for Staff Engagement

Clinical staff seeking to improve engagement in clinic-based research studies and increase their knowledge of basic research principles can use these training materials and best practices for implementing studies in clinical settings and communicating with clinical support staff. Content and format for the resources were informed by both clinic staff and research team members who conduct studies in clinical settings.

Access the resources here.

PaTH to Health Just-In-Time Study Results and Dissemination Training

The PaTH Clinical Research Network (CRN) designed this training explaining the benefits and limitations of observational studies, common data issues and how to manage them via the PaTH to Health Diabetes Study.

Access the resource here.