Support Available from the PASA Management Core
Support for Application
During your proposal development, statisticians from the PASA Management Core are available to provide you support to provide new or review existing power/sample size calculations and analytic plans. If you would like the support of PASA statisticians, please contact the PASA RFA e-mail,
PASA_RFA@rti.org. Please note that any help provided is by recommendation only; and it is your choice on whether to include in your proposal.
Support for Project (pending approval of application)
PASA provides centralized management/oversight, data management and statistical staff to support PASA funded projects. Details of the support these individuals provide are listed below. Please note that this staffing and associated activities do not need to be duplicated at your site nor included in your budget as they are covered by the PASA Management Core funds. However, any site-specific needs for study management (e.g., lab oversight) or data management (e.g., data entry) should be staffed at the site and budgeted for in your proposal. Additionally, if you have analytic support from your site that you would like to incorporate, you may do so but must include this in your budget; and these individuals would be expected to work collaboratively with the existing PASA statisticians to plan, complete and/or review any conducted analyses.
- Coordinating communications and meetings between funded investigators and PASA Core team
- Tracking project progress per contractual SOW
- Reviewing and editing documents
- Site monitoring (remote and in-person) and visits as needed
- Reporting on study status for Congressionally Directed Medical Research Program (CDMRP)
Clinical Implementation Strategy (CIS)
- Facilitating meetings with potential pharmaceutical collaborators
- Coordinating development of CIS
Regulatory
- Coordinating Pre-IND meeting coordination
- Facilitating a response to FDA comments
- Submitting protocol for final FDA consideration
Protocol
- Refining study design including analytic and randomization approach
- Facilitating identification of study sites and study budget development
- Obtaining Data Safety and Monitoring Board (DSMB) approval of protocol
Data Management
- Identifying case report forms (CRFs)
Funding Consideration
- Submitting CDP, Protocol, and budget to CDMRP for study funding consideration
Protocol
- Refining study design including analytic and randomization approach
- Developing statistical analysis plan and randomization schema
- Coordinating Manual of Procedures (MOP) and Quality Assessment Plan (QAP) development
Regulatory
- Submitting protocol to ACURO (pre-clinical only)
- Tracking approvals by IACUC and ACURO (pre-clinical only)
Implementation
- Supporting file-based data transfer and storage in data repository
- Reporting of study status for protocol team and through dashboards
- Analyzing data and interpreting results
- Interpreting results and contributing to manuscript development
Protocol
- Refining study design including analytic and randomization approach
- Developing statistical analysis plan and randomization schema
- Coordinating Manual of Procedures (MOP) and Quality Management Plan (QMP) development
- Conducting site training in collaboration with PI
Regulatory
- Submitting protocol to OHRO and if applicable, FDA
- Tracking approvals by IRB, OHRO and if applicable, FDA
- Completing FDA annual reporting
Data Management
- Finalizing CRFs
- Determining required edit-checks
- Building and managing randomization and electronic data capture systems
Implementation
- Providing pharmacovigilance support
- Reporting of study status for DSMB and protocol team as well as through dashboards
- Monitoring data quality and site conduct
- Analyzing data and interpreting results
- Interpreting results and contributing to manuscript development
- Providing support listed under the relevant type of study proposed (i.e., drug discovery study, pre-clinical study, or clinical trial)
